A Multicenter Clinical Study on the Safety and Effectiveness of CAR-T in the Treatment of Relapsed/Refractory Hodgkin's Lymphoma

Hodgkin's Lymphoma Clinical Trial

Official title:

A Multicenter Clinical Study on the Safety and Effectiveness of CAR-T in the Treatment of Relapsed/Refractory Hodgkin's Lymphoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04665063
• Other study ID #: 2020103
• Status: Recruiting
• Phase: N/A
• Start date: October 22, 2020
• Est. completion date: October 21, 2025

Study information

• Verified date: October 2020
• Source: Hebei Senlang Biotechnology Inc., Ltd.
• Contact: Jianqiang Li, PhD & MD
• Phone: 008615511369555
• Email: limmune[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is a multi-center, non-randomized, single-arm, open clinical trial.

Description:

A single car consists of scFv, hinge region, transmembrane region, costimulatory domain and zeta subunit of CD3.Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 21, 2025
• Est. primary completion date: October 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the visits, treatment plans, laboratory inspections, and other requirements of the research as specified in the test procedure;

2. Hodgkin lymphoma patients who are judged to be relapsed/refractory by clinical diagnosis, relapse or refractory are defined as:

1. Primary resistance to standard treatment regimens;

2. Or PD occurs after standard treatment with at least second-line standard treatment plan;

3. Or the last treatment effect is SD and the duration does not exceed 6 months;

4. Or after anti-PD-1 monoclonal antibody treatment is ineffective or relapses;

5. Patients who have PD after autologous hematopoietic stem cell transplantation or confirmed recurrence by biopsy within 12 months, or patients who undergo salvage treatment after autologous hematopoietic stem cell transplantation have no remission or relapse after treatment.

3. According to RECIST version 1.1 , there should be at least one measurable tumor;

4. Subjects whose physical status scored by the Eastern Cooperative Oncology Group (ECOG) is 0~2;

5. 14 years old = age = 75 years old, both male and female;

6. Immunohistochemistry or flow cytometry detects tumor cells as CD30 or CD19/CD22/CD79 positive;

7. The estimated survival period from the date of signing the informed consent form is greater than 3 months;

8. Laboratory examinations meet the following conditions: hemoglobin =80g/L, platelet count =50 × 109/L, absolute neutrophil count (ANC) =1.0 × 109/L, if the investigator believes that the above inspection value is below the lower limit It is caused by tumor invading bone marrow and can be included in the group after consultation with the sponsor;

9. The main organ functions need to meet the following conditions: serum creatinine =1.5 ULN, AST (aspartate aminotransferase)/ALT (alanine aminotransferase)/ALP (alkaline phosphatase) =2.5 ULN, total bilirubin =1.5 ULN, left Ventricular ejection fraction (LVEF) =50%, and minimum lung function reserve (dyspnea is not higher than level 1 and blood oxygen saturation is greater than 92% under indoor conditions).

Exclusion Criteria:

1. Severe cardiac insufficiency, left ventricular ejection fraction <50%;

2. There is a history of severe lung dysfunction diseases;

3. The patient has had other malignant tumors in the past 5 years, except for skin basal cell carcinoma, breast carcinoma in situ and cervical carcinoma in situ that have undergone radical treatment;

4. Combined with severe or persistent infection and cannot be effectively controlled; Severe infection: Refers to sepsis or uncontrolled infection of the infected foci, and can be included in the group after infection is controlled

5. Combined metabolic diseases (except diabetes);

6. Combined with severe autoimmune disease or innate immune deficiency;

7. Untreated active hepatitis (hepatitis B, defined as hepatitis B virus surface antigen [HBsAg] test results are positive, HBV-DNA = 500 IU/ml and abnormal liver function; hepatitis C, defined as hepatitis C antibody [ HCV-Ab] positive, HCV-RNA higher than the detection limit of the analysis method and abnormal liver function) or combined with hepatitis B and C co-infection;

8. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection;

9. A history of severe allergies to biological products (including antibiotics);

10. Participate in any other clinical drug trials at the same time within one month;

11. There are other serious physical or mental illnesses or laboratory abnormalities that may increase the risk of participating in the research, or interfere with the results of the research, and patients who the researcher believes are not suitable for participating in this research.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin's Lymphoma
• Lymphoma

Intervention

Biological:
• Auto CAR-T
Biological: Auto CAR-T

Drug:
• Cyclophosphamide,Fludarabine
Drug: Cyclophosphamide,Fludarabine

Procedure:
• Leukapheresis
Leukapheresis

Locations

Country	Name	City	State
China	Hematology Department, Hebei Medical University Fourth Hospital	Shijiazhuang	Hebei

Sponsors (2)

Lead Sponsor	Collaborator
Hebei Senlang Biotechnology Inc., Ltd.	Hebei Medical University Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence and severity of adverse events	To evaluate the possible adverse events occurred within first one month after CAR-T infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity	first one month after CAR-T infusion
Primary	Efficacy: Remission Rate	Remission Rate including complete remission (CR), partial remission (PR), objective response (ORR = CR + PR), disease stability (SD), disease progression (PD) and and unresponsive (NR)	3 months post CAR-T cells infusion
Secondary	Efficacy:duration of response (DOR)	duration of response (DOR)	24 months after CAR-T infusion
Secondary	Efficacy: progression-free survival (PFS)	progression-free survival (PFS) time	24 months after CAR-T infusion