Lymphoma Clinical Trial
Official title:
Phase Ib/II Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor (CAR) for Relapsed/Refractory CD30+ Hodgkin's Lymphoma and CD30+ Non-Hodgkin's Lymphoma
The body has different ways of fighting infection and disease. No single way seems perfect for fighting cancer. This research study combines two different ways of fighting disease: antibodies and T cells. Antibodies are proteins that protect the body from disease caused by bacteria or toxic substances. Antibodies work by binding those bacteria or substances, which stops them from growing and causing bad effects. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including tumor cells or cells that are infected. Both antibodies and T cells have been used to treat patients with cancers. They both have shown promise, but neither alone has been sufficient to cure most patients. This study is designed to combine both T cells and antibodies to create a more effective treatment called autologous T lymphocyte chimeric antigen receptor cells targeted against the CD30 antigen (ATLCAR.CD30) administration. In previous studies, it has been shown that a new gene can be put into T cells that will increase their ability to recognize and kill cancer cells. The new gene that is put in the T cells in this study makes an antibody called anti-CD30. This antibody sticks to lymphoma cells because of a substance on the outside of the cells called CD30. Anti-CD30 antibodies have been used to treat people with lymphoma, but have not been strong enough to cure most patients. For this study, the anti-CD30 antibody has been changed so that instead of floating free in the blood it is now joined to the T cells. When an antibody is joined to a T cell in this way it is called a chimeric receptor. These CD30 chimeric (combination) receptor-activated T cells seem to kill some of the tumor, but they do not last very long in the body and so their chances of fighting the cancer are unknown. The purpose of this research study is to establish a safe dose of ATLCAR.CD30 cells to infuse after lymphodepleting chemotherapy and to estimate the number patients whose cancer does not progress for two years after ATLCAR.CD30 administration. This study will also look at other effects of ATLCAR.CD30 cells, including their effect on the patient's cancer.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | August 26, 2040 |
| Est. primary completion date | August 26, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 3 Years and older |
| Eligibility | Inclusion Criteria Prior to Cell Procurement Informed consent explained to, understood by and signed by the subject or legal guardian for pediatric subjects; subject and/or legal guradian given a copy of informed consent form for procurement Ages 3 to 17 years of age for pediatric subjects (weight must be =10kg), and for adults ages =18 years of age Diagnosis of recurrent HL or NHL in subjects who have failed >2 prior treatment regimens. Subjects relapsed after autologous or allogeneic stem cell transplant are eligible for this study. CD30+ disease (result can be pending at the time of cell procurement, but must be confirmed prior to treatment with ATLCAR.CD30 cells). NOTE: CD30+ disease requires documented CD30 expression by immunohistochemistry based on the institutional hematopathology standard. Karnofsky or Lansky score of >60% (Karnofsky for =16 years old and Lansky for <16 years old) Evidence of adequate organ function as defined by: - Hemoglobin = 8.0 g/dL (transfusion independent for 2 weeks prior to enrollment) - Total bilirubin = 1.5 × ULN, unless attributed to Gilbert's Syndrome - AST = 3 × ULN - Serum creatinine = 1.5 × ULN - For subjects <18 years old use the following table for serum creatinine requirements: Maximum Serum Creatinine (mg/dL) Age (years) Male Female 3 to <6 =0.8 =0.8 6 to <10 =1.0 =1.0 10 to <13 =1.2 =1.2 13 to <16 =1.5 =1.4 =16 and <18 =1.7 =1.4 Negative serum pregnancy test in females within 72 hours prior to procurement or documentation that the subject is post-menopausal or premenarchal. Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for >1 year. • Postmenopausal status must be confirmed with documentation of absence of menses for >1 year. Exclusion Criteria Prior to Cell Procurement Pregnant or lactating Tumor in a location where enlargement could cause airway obstruction Must not have an Active infection with human immunodeficiency virus (HIV), Hepatitis B Virus (HBV))or, Hepatitis C virus (HCV) (can be pending at the time of cell procurement; only subjects meeting the criteria as so described will be infused). Note: To meet eligibility subjects are required to have negative HIV antibody, negative for Hepatitis B surface antigen and negative for HCV antibody or viral load. Inclusion Criteria Prior to Lymphodepletion Informed consent explained to, understood by and signed by the subject or legal guardian for pediatric subjects; subject and/or legal guradian given a copy of informed consent form. CD30+ disease (result can be pending at the time of cell procurement, but must be confirmed prior to lymphodepletion); Note: CD30+ disease requires documented CD30 expression by immunohistochemistry based on the institutional hematopathology standard. Prior to administration of lymphodepletion: - Absolute neutrophil count (ANC) is > 1.0 × 10^9/L - Platelet count > 75 × 10^9/L - For Grade 4 neutropenia, Grade =3 febrile neutropenia, or Grade 4 thrombocytopenia, hold bendamustine until toxicity resolve to Grade =2 For WOCBP negative serum pregnancy test within 72 hours prior to lymphodepletion. Imaging results from within 7 days (30 days in subjects with cutaneous T cell lymphoma) prior to lymphodepletion. Subjects who have received bridging chemotherapy must have imaging performed at least 3 weeks after most recent therapy (imaging does not need to be repeated if it is within 7 days prior to lymphodepletion). Karnofsky or Lansky score of >60% (Karnofsky for pediatric subjects =16 years old and Lansky for <16 years old). Available autologous transduced activated T cells that meet the Certificate of Analysis (CofA) acceptance criteria. Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year. Exclusion Criteria Prior to Lymphodepletion Received any investigational agents or received any tumor vaccines within the previous six weeks prior to cell infusion. Received anti-CD30 antibody-based therapy within the previous 4 weeks prior to cell infusion. Received chemotherapy within the previous 3 weeks prior to lymphodepletion. Subject has rapidly progressive disease, per treating oncologist's discretion. Subject is not a good candidate for CAR T cell therapy, per treating oncologist's discretion. Pregnant or lactating. Tumor in a location where enlargement could cause airway obstruction. Current use of systemic corticosteroids at doses equivalent of =10mg prednisone daily or its equivalent; those receiving <10mg daily may be enrolled at discretion of investigator. Inhaled steroids are allowed. For pediatric subjects, physiologic replacement hydrocortisone at doses 6-12 mg/m2/day is allowed. Equivalently dosed alternative steroids are allowed at discretion of investigator, though not to exceed 10mg prednisone per day. Inhaled steroids are allowed. Subjects on strong inhibitors of CYP1A2 (e.g., fluvoxamine, ciprofloxacin) as these may increase plasma concentrations of bendamustine, and decrease plasma concentrations of its metabolites. See http://medicine.iupui.edu/clinpharm/ddis/ for an updated list of strong inhibitors of CYP1A2. Details are given in the protocol.(This applies to subjects who receive bendamustine for lymphodepletion (required) up through 72 hours after the last dose of bendamustine.) Active infection with HIV, HBV or HCV (can be pending at the time of cell procurement; only subjects meeting the criteria as so described will be infused. Subjects are required to have negative HIV antibody or negative for Hepatitis B surface antigen and negative HCV antibody or viral load. Hepatitis B: Subjects who are positive for Hepatitis B Surface Antigen are excluded. Subjects who are Hepatitis B Surface Antigen negative but hepatitis B core Antibody positive must have their hepatitis B viral load checked. These subjects will be excluded if their viral load is positive at baseline. Subjects who are core antibody positive and viral load negative at baseline will be considered eligible if the subject has initiated an anti-HBV prophylaxis regimen prior to lymphodepletion. Inclusion Criteria Prior to Infusion of ATLCAR.CD30 Cells Evidence of adequate organ function as defined by: - Total bilirubin =1.5 × ULN, unless attributed to Gilbert's Syndrome - AST =3 × ULN - Serum creatinine =1.5 × ULN - Pulse oximetry of >90% on room air - For subjects <18 years old use following table for serum creatinine requirements: Maximum Serum Creatinine (mg/dL) Age (years) Male Female 3 to <6 =0.8 =0.8 6 to <10 =1.0 =1.0 10 to <13 =1.2 =1.2 13 to <16 =1.5 =1.4 =16 and <18 =1.7 =1.4 Karnofsky or Lansky score of >60% (Karnofsky for =16 years old and Lansky for <16 years old) Available autologous transduced activated T cells that meet the Certificate of Analysis (CofA) acceptance criteria. Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year. Exclusion Criteria Prior to Infusion of ATLCAR.CD30 Cells Received any investigational agents or received any tumor vaccines within the previous six weeks prior to cell infusion. Received anti-CD30 antibody-based therapy within the previous 4 weeks prior to cell infusion. Tumor in a location where enlargement could cause airway obstruction. Subject has rapidly progressive disease, per treating oncologist's discretion. Subject is not a good candidate for CAR T cell therapy, per treating oncologist's discretion. Current use of systemic corticosteroids at doses =10 mg prednisone daily or its equivalent; those receiving <10 mg daily may be enrolled at discretion of investigator. Inhaled steroids are allowed For pediatric subjects, physiologic replacement hydrocortisone at doses 6-12mg/m2/day is allowed. Equivalently dosed alternative steroids are allowed at discretion of investigator, though not to exceed 10mg prednisone per day. Inhaled steroids are allowed. Active infection with HIV or HCV (can be pending at the time of cell procurement; only subjects meeting the criteria as so described will be infused). Subjects are required to be negative for HIV and negative for Hepatitis B surface antigen, and negative HCV antibody or viral load. Hepatitis B: Subjects who are positive for Hepatitis B Surface Antigen are excluded. Subjects who are Hepatitis B Surface Antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked. These subjects will be excluded if their viral load is positive at baseline. Subjects who are core antibody positive and viral load negative at baseline will be considered eligible. These subjects must be receiving antiviral prophylaxis initiated prior to lymphodepletion. Eligibility Criteria Prior to Lymphodepletion for Second Infusion (Optional) Note: Subjects may receive a second infusion without prior lymphodepletion if they meet the eligibility criteria at the time of infusion, but do not meet the eligibility requirements for adequate bone marrow function and platelet counts. Karnofsky or Lansky score of >60% (Karnofsky for =16 years old and Lansky for <16 years old). WOCBP must be willing to use 2 methods of birth control or be surgically sterile , or abstain from heterosexual activity for the course of the study, or for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year. Subject must not be pregnant or lactating within 7 days of infusion. Must not have tumor in a location where enlargement could cause airway obstruction. Subjects must have imaging results confirming active disease from within 30 days prior to lymphodepletion with the exception of cutaneous lymphoma subjects who do not need to repeat scans prior to the second cell infusion if the baseline scans showed lymph nodes = 1.5cm at baseline. Must not have current use of systemic corticosteroids at doses =10 mg prednisone daily or its equivalent; those receiving <10mg daily may be enrolled at discretion of the Investigator Evidence of adequate organ function as defined by: - ANC>1.0 × 10^9/L - Platelets >75 × 10^9/L - Total bilirubin =1.5 × ULN, unless attributed to Gilbert's syndrome - AST =3 × ULN - Serum creatinine =1.5 × ULN - Pulse oximetry of > 90% on room air - For subjects <18 years old use following table for serum creatinine requirements: Maximum Serum Creatinine (mg/dL) Age (years) Male Female 3 to <6 =0.8 =0.8 6 to <10 =1.0 =1.0 10 to <13 =1.2 =1.2 13 to <16 =1.5 =1.4 =16 and <18 =1.7 =1.4 Negative serum pregnancy test within 72 hours prior to lymphodepletion or documentation that the subject is post-menopausal. Post-menopausal status must be confirmed with documentation of absence of menses for > 1 year or documentation of surgical menopause involving bilateral oophorectomy. Subject cannot be on strong inhibitors of CYP1A2 (e.g., fluvoxamine, ciprofloxacin) as these may increase plasma concentrations of bendamustine, and decrease plasma concentrations of its metabolites. See http://medicine.iupui.edu/clinpharm/ddis/ for an updated list of strong inhibitors of CYP1A2. (This applies to subjects who receive bendamustine for lymphodepletion (required) up through 72 hours after the last dose of bendamustine) Subject is a good candidate for treatment with ATLCAR.CD30 per the investigator's discretion. Eligibility Criteria Prior to Second Infusion (Optional) No evidence of uncontrolled infection or sepsis. Subject must not have undergone bridging chemotherapy (or other anti-cancer therapies, which are not mandated by the protocol) prior to the second infusion. Evidence of adequate organ function as defined by: - Total bilirubin =2 × ULN, unless attributed to Gilbert's syndrome - AST =3 × ULN - ALT =3 × ULN - Serum creatinine =1.5 × ULN - Pulse oximetry of >90% on room air - For subjects <18 years old use following table for serum creatinine requirements: Maximum Serum Creatinine (mg/dL) Age (years) Male Female 3 to <6 =0.8 =0.8 6 to <10 =1.0 =1.0 10 to <13 =1.2 =1.2 13 to <16 =1.5 =1.4 =16 and <18 =1.7 =1.4 Subject has no clinical indication of rapidly progressing disease in the opinion of the treating physician Subject is a good candidate for treatment with ATLCAR.CD30 per the investigator's discretion. If subjects have had positive hepatitis B core antibody testing at baseline, they must not have had re-activation of the Hepatitis B virus since baseline testing. Subject must not be pregnant or lactating within 7 days of infusion. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| UNC Lineberger Comprehensive Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of participants with adverse events as a measure of safety and tolerability of ATLCAR.CD30 cells to establish a safe dose after lymphodepletion with bendamustine in adult patients | Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE | 6 weeks | |
| Primary | Number of participants with adverse events as a measure of safety and tolerability of ATLCAR.CD30 cells to establish a safe dose after lymphodepletion after lymphodepletion with bendamustine and fludarabine in pediatric patients | Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE | 6 weeks | |
| Primary | 2 year progression free survival (PFS) after administration of ATLCAR.CD30 in combined adult/pediatric patients with CD30+ refractory/relapsed HL and NHL. | PFS is defined from day of ATLCAR.CD30 infusion to relapse (in patients with a documented complete response at time of cell infusion) or progression (in patients without complete response at time of cell infusion), or death as a results of any cause per the Lugano classification. | 2 years | |
| Secondary | 2 year overall survival (OS) after administration of CAR.CD30 transduced ATL following lymphodepletion with bendamustine and fludarabine in adult and pediatric patients with CD30+ relapsed/refractory HL and NHL. | Overall survival will be measured from the date of administration of CAR.CD30 transduced ATL to the date of death and will be measured in subjects receiving a combination of bendamustine and fludarabine for lymphodepletion. | 2 years | |
| Secondary | 2 year overall survival (OS) after administration of ATLCAR.CD30 transduced ATl following lymphodepletion with bendamustine in adult patients with CD30+ refractory/relapsed HL and NHL | Overall survival will be measured from the date of administration of CAR.CD30 transduced ATL to date of death and will be measured in subjects receiving bendamustine alone. | 2 years | |
| Secondary | 2 year progression free survival after administration of ATLCAR.CD30 following lymphodepletion with bendamustine in adult patients with CD30+ in adult patients with CD30+ refractory/relapsed HL and NHL. | Progression free survival is defined from day of ATLCAR.CD30 infusion to relapse (in patients with a documented complete response at time of cell infusion) or progression (in patients without complete response at time of cell infusion), or death as a result of any cause per the Lugano classification and will be measured in subjects receiving bendamustine alone. | 2 years | |
| Secondary | 2 year progression free survival after administration of ATLCAR.CD30 following lymphodepletion with bendamustine and fludarabine in adult and pediatric patients with CD30+ refractory/relapsed HL and NHL. | Progression free survival is defined from day of ATLCAR.CD30 infusion to relapse (in patients with a documented complete response at time of cell infusion) or progression (in patients without complete response at time of cell infusion), or death as a result of any cause per the Lugano classification and will be measured in subjects receiving a combination of bendamustine and fludarabine for lymphodepletion. | 2 years | |
| Secondary | Objective response rate as defined by the Lugano Classification for CAR.CD30 transduced ATL following lymphodepletion with bendamustine when administered in adult patients with CD30+ relapsed/refractory HL and NHL | The objective response rate will be defined as the rate of complete responses (CR) + partial responses (PR) as determined by the Lugano classification and will be measured in subjects receiving bendamustine alone for lymphodepletion. | 6 weeks | |
| Secondary | Objective response rate as defined by the Lugano classification for CAR.CD30 transduced ATL following lymphodepletion with bendamustine and fludarabine when administered in adult and pediatric patients with CD30+ relapsed/refractory HL and NHL. | The objective response rate will be defined as the rate of complete responses (CR) + partial responses (PR) as determined by the Lugano classification and will be measured in subjects receiving bendamustine and fludarabine for lymphodepletion. | 6 weeks | |
| Secondary | Duration of response after administration of CAR.CD30 transduced ATL following lymphodepletion with bendamustine in adult patients with CD30+ relapsed/refractory HL and NHL. | Duration of response will be defined as time from documentation of tumor response to disease progression and will be measured in subjects receiving bendamustine alone for lymphodepletion. | 15 years | |
| Secondary | Duration of response after administration of CAR.CD30 transduced ATL following lymphodepletion with bendamustine and fludarabine in adult and pediatric patients with CD30+ relapsed/refractory HL and NHL. | Duration of response will be defined as time from documentation of tumor response to disease progression and will be measured in subjects receiving a combination of bendamustine and fludarabine for lymphodepletion. | 15 years | |
| Secondary | Adverse events associated with CAR.CD30 transduced ATL when administered in adult and pediatric patients with CD30+ relapsed/refractory HL and NHL. | Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). | 6 weeks | |
| Secondary | Number of participants with adverse events as a measure of safety and tolerability of bendamustine and fludarabine as lymphodepleting agents | Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). | 6 weeks | |
| Secondary | Number of adverse events as a measure of safety and tolerability of bendamustine and fludarabine as lymphodepleting agents prior to infusion of CAR.CD30 transduced ATLs in pediatric patients. | Toxicity will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 4.0). | 6 weeks | |
| Secondary | Survival of ATLCAR.CD30 in vivo when infused after lymphodepletion with bendamustine. | Persistence of CAR.CD30 T cells in vivo will be determined by quantitative PCR and flow cytometry in peripheral blood samples and will be measured in subjects receiving bendamustine alone for lymphodepletion. | 15 years | |
| Secondary | To measure the survival of ATLCAR.CD30 in vivo when infused after lymphodepletion with bendamustine and fludarabine. | Persistence of CAR.CD30 T cells in vivo will be determined by quantitative PCR and flow cytometry in peripheral blood samples and will be measured in subjects receiving bendamustine in combination with fludarabine for lymphodepletion | 15 years | |
| Secondary | Measure patient-reported symptoms using selected symptom items from the NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) at baseline and over time in adult patients treated with CAR.CD30 T cells. | The NCI Patient Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE) is a patient-reported outcome measurement system developed to characterize the frequency, severity and interference of 78 symptomatic treatment toxicities. Each item is scored from 0 to four. | 15 years | |
| Secondary | Measure patient-reported quality of life using the PROMIS Global Health (PROMIS GHS SF v1.0-1.1) at baseline and over time in adult patients treated with CAR.CD30 T cells. | The PROMIS Global Health Short Form is a 10-item instrument representing multiple domains relating to overall health. Each item has a scale from 1 (poor) to 5 (excellent). Item 7, 8, and 10 are recoded. The global physical health score is generated by summing responses to Global03, Global06, Global07 rescored, Global08 rescored. The Global Mental Health score is generated by summing responses to Global02, Global04, Global05, Global10 Rescored. | 15 years | |
| Secondary | Measure patient reported quality of life using the PROMIS Physical Function (PROMIS Physical Function SF20a) at baseline and over time in adult patients treated with CAR.CD30 T cells. | The PROMIS Physical Function short form is a 20 item instrument that measures self-reported capability rather than actual performance of physical activities. This includes the functioning of one's upper extremities (dexterity), lower extremities (walking or mobility), and central regions (neck, back), as well as instrumental activities of daily living, such as running errands. Each item has five response options ranging in value from 1 (unable to do) to 5 (without any difficulty). To items are summed to find the overall raw score. | 15 years |
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