Status:
COMPLETED
A Study of C-CAR066 in Subjects With r/r B Cell Lymphoma Who Received CD19 CAR-T Therapy
Lead Sponsor:
Shanghai Tongji Hospital, Tongji University School of Medicine
Collaborating Sponsors:
Shanghai AbelZeta Ltd.
Conditions:
B Cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
This is a single-center, non-randomized clinical study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r B cell lymphoma who received CD19 CAR-T therapy.
Detailed Description
This study plans to enroll 10 patients to assess the safety and efficacy of C-CAR066. Subjects who meet the eligibility criteria will receive a single dose of C-CAR066 injection. The study will inclu...
Eligibility Criteria
Inclusion
- The patient volunteered to participate in the study, and signed the Informed Consent
- Age 18-70 years old, male or female
- Patients with CD20+ DLBCL (including PMBCL and tFL), FL and MCL, at least one measurable lesion (LDi≥ 1.5 cm)
- r/r lymphoma patients who received prior CD19 CAR-T therapy
- At least one week from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
- No immunosuppressive therapy was used within 1 week before C-CAR066 infusion
- No mAb treatment within 2 weeks before C-CAR066 infusion
- Adequate organ and bone marrow function
- No contraindications of apheresis
- Expected survival time \> 3 months
- ECOG scores 0-1
Exclusion
- Have a history of allergy to cellular products
- Patients with cardiac insufficiency classified as Class III or IV according to the New York Heart Association (NYHA) Heart Function Classification Standard
- A history of craniocerebral trauma, consciousness disorder, epilepsy, cerebral ischemia or hemorrhagic cerebrovascular disease
- Patients with active CNS involvement
- Patients with autoimmune disease, immunodeficiency, or other treatment requiring immunosuppressor
- Severe active infection (except simple urinary tract, bacterial pharyngitis), or currently receiving intravenous antibiotics. However, prophylactic antibiotics, antiviral and antifungal treatments are allowed
- Live vaccination within 4 weeks before apheresis
- HIV, HBV, HCV and TPPA / RPR infections, and HBV carriers
- Have a history of alcoholism, drug addiction and mental illness
- Non-sterile subjects had any of the following: a) being pregnant / lactating; or b) having a pregnancy plan during the trial; or c) having fertility without taking effective contraception
- Patients with severe fludarabine or cyclophosphamide hypersensitivity
- The patient has a history of other primary cancers, except for the following:
- Non-melanoma such as skin basal cell carcinoma cured by resection
- Cured carcinoma in situ such as cervical, bladder or breast cancer
- The investigators believe that there are other circumstances that are not suitable for the trial
Key Trial Info
Start Date :
August 20 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2022
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT04036019
Start Date
August 20 2019
End Date
June 20 2022
Last Update
May 28 2024
Active Locations (1)
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1
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, China, 200065