Non-Hodgkin's Lymphoma Clinical Trial
Official title:
Phase I Study of the Administration of T Lymphocytes Expressing the CD30 Chimeric Antigen Receptor for Relapsed CD30+ Hodgkin's Lymphoma and CD30+ Non-Hodgkin's Lymphoma (CART CD30)
Verified date | March 2023 |
Source | UNC Lineberger Comprehensive Cancer Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 diseases caused by germs or toxic substances. They work by binding those germs 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 with germs. Both antibodies and T cells have been used to treat patients with cancers: they both have shown promise, but have not been strong enough to cure most patients. Investigators hope that both will work better together. Investigators have found from previous research that they can put a new gene into T cells that will make them recognize cancer cells and kill them. Investigators now want to see if they can attach a gene to T cells that will help them do a better job at recognizing and killing lymphoma cells. The new gene that investigators will put in T cells 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 receptor-activated T cells seem to kill some of the tumor, but they don't last very long and so their chances of fighting the cancer are unknown.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 4, 2022 |
Est. primary completion date | January 28, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | INCLUSION CRITERIA Procurement Inclusion Criteria: Referred patients will initially be consented for procurement of blood for generation of the transduced ATL. Eligibility criteria at this stage include: - Diagnosis of recurrent CD30+ HL or CD30+ NHL, or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory CD30+ HL or CD30+ NHL with a treatment plan that will include high dose therapy and stem cell transplantation - CD30 positive tumor (result can be pending at this time) - Hgb > 8.0 - Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. - Karnofsky or Lansky score greater than 60% Procurement Exclusion Criteria - Active infection with HIV, HTLV, HBV, HCV (can be pending at this time). Treatment Inclusion Criteria: Diagnosis - CD30+ HL or CD30+ NHL: 1. During the Dose Escalation Phase: only adult patients with active disease failing standard therapy 2. After Dose Escalation: any patient (children or adults) newly diagnosed, unable to receive or complete standard therapy OR diagnosis of relapsed/refractory CD30+ HL or CD30+ NHL with a treatment plan that will include high dose therapy and autologous stem cell transplantation. (During dose escalation: only adult patients (age 18 and older; After Dose Escalation: any patient (children ages 0-17 or adults) - CD30 positive tumor - Bilirubin 1.5 times or less than upper limit of normal. - AST 3 times or less than upper limit of normal. - Serum creatinine 1.5 times or less than upper limit of normal. - Pulse oximetry of > 90% on room air - Karnofsky or Lansky score of > 60%. - Available autologous T cells with 15% or more expression of CD30CAR determined by flow-cytometry. - Recovered from acute toxic effects of all prior chemotherapy at least one week and 30 days from prior chemotherapy before entering this study - Adequate pulmonary function with FEV1, FVC and DLCO greater than or equal to 50% of expected corrected for hemoglobin. - Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom. - Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form. EXCLUSION CRITERIA: Procurement Exclusion Criteria: - Active infection with HIV, HTLV, HBV, HCV (can be pending at this time). Treatment Exclusion Criteria: - Currently receiving any investigational agents or received any tumor vaccines within the previous six weeks. - Received anti-CD30 antibody-based therapy within the previous 4 weeks. - History of hypersensitivity reactions to murine protein-containing products. - Pregnant or lactating. - Tumor in a location where enlargement could cause airway obstruction. - Current use of systemic corticosteroids. |
Country | Name | City | State |
---|---|---|---|
United States | University of North Carolina Chapel Hill | Chapel Hill | North Carolina |
United States | Houston Methodist Hospital | Houston | Texas |
United States | Texas Children's Hospital | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
UNC Lineberger Comprehensive Cancer Center | Baylor College of Medicine, Center for Cell and Gene Therapy, Baylor College of Medicine, The Methodist Hospital Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants with adverse events as a measure of safety and tolerability of escalating doses of autologous activated T lymphocytes | To evaluate the safety of escalating doses of autologous activated T lymphocytes (ATL), genetically modified to express an artificial chimeric antigen receptor (CAR) that targets the CD30 molecule (CAR.CD30) and also contains the CD28 endodomain, in patients with CD30+ refractory/relapsed Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL). | 6 weeks | |
Secondary | Measure the survival of CAR.CD30 in vivo | To measure the survival of CAR.CD30 transduced ATL in vivo. | 15 years | |
Secondary | Measure the response of the subjects tumor to the CAR.CD30 transduced ATL | To measure the anti-tumor effects of CAR.CD30 transduced ATL in patients with CD30+ refractory/relapsed Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL). | 15 years |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT03844048 -
An Extension Study of Venetoclax for Subjects Who Have Completed a Prior Venetoclax Clinical Trial
|
Phase 3 | |
Completed |
NCT01878890 -
Phase I Dose Escalation Trial of Efavirenz in Solid Tumours or Non-Hodgkin Lymphoma in Therapeutic Failure.
|
Phase 1 | |
Completed |
NCT04152148 -
A Phase I Clinical Trial of BAT4306F on Safety, Tolerability and Pharmacokinetics for Patients
|
Phase 1 | |
Recruiting |
NCT05096234 -
18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma
|
Phase 2 | |
Recruiting |
NCT05191225 -
Ultrafast Truxima Infusion in Non-Hodgkin's Lymphoma: Txagorapid Study
|
Phase 4 | |
Recruiting |
NCT05623982 -
Phase Ib/II Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT03664635 -
MB-CART20.1 Lymphoma
|
Phase 1/Phase 2 | |
Recruiting |
NCT02356159 -
Study of Palifermin (Kepivance) in Persons Undergoing Unrelated Donor Allogeneic Hematopoietic Cell Transplantation
|
Phase 1/Phase 2 | |
Terminated |
NCT01699581 -
Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant
|
Phase 2 | |
Completed |
NCT01763398 -
Analysis of the Risk Factors for the Neutropenic Fever in the High Risk NHL Patients for Developing Febrile Neutropenia Who Received 3-weekly CHOP-like Chemotherapy With Primary G-CSF Prophylaxis; Prospective Multicenter Observation Study
|
N/A | |
Completed |
NCT01205503 -
Trial of Mesna to Prevent Doxorubicin-induced Plasma Protein Oxidation and Tumor Necrosis Factor Alpha (TNF-α) Release
|
Phase 2 | |
Completed |
NCT00969462 -
Doxorubicin Pharmacokinetics and Response in Non Hodgkin's Lymphoma
|
Phase 4 | |
Completed |
NCT00975975 -
Basiliximab #2: In-Vivo Activated T-Cell Depletion to Prevent Graft-Versus_Host Disease (GVHD) After Nonmyeloablative Allotransplantation for the Treatment of Blood Cancer
|
Phase 2 | |
Completed |
NCT00659425 -
CAT-8015 in Children, Adolescents and Young Adults With Acute Lymphoblastic Leukemia or Non-Hodgkin's Lymphoma
|
Phase 1 | |
Completed |
NCT00533728 -
Safety of Soluble Beta-Glucan (SBG) in Treatment of Patients With Non-Hodgkin's Lymphoma
|
Phase 1 | |
Completed |
NCT00608907 -
An Open-Label Study to Assess the Effect of CYP3A4 Induction on the Pharmacokinetics of VELCADE (Bortezomib)
|
Phase 1 | |
Terminated |
NCT00475332 -
Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar
|
Phase 2 | |
Withdrawn |
NCT00577161 -
Fludarabine, Pixantrone and Rituximab vs Fludarabine and Rituximab forRelapsed or Refractory Indolent NHL
|
Phase 3 | |
Completed |
NCT00430352 -
MAXIMA Study: A Study of Maintenance Therapy With MabThera (Rituximab) in Patients With Non-Hodgkin's Lymphoma.
|
Phase 4 | |
Completed |
NCT00581646 -
Study of Psychosexual Impact of Cancer-Related Infertility in Women: Third Party Reproductive Assistance
|
N/A |