Status:
COMPLETED
A Study of C-CAR066 in Subjects With r/r Diffuse Large B Cell Lymphoma Who Received CD19 CAR-T Therapy
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Collaborating Sponsors:
Shanghai AbelZeta Ltd.
Conditions:
Diffuse Large B Cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of C-CAR066 in treatment of r/r DLBCL 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 18-75 years old, male or female
- Patients diagnosed with diffuse large B-cell lymphoma (DLBCL, De novo or transformed) histologically according to the 2016 WHO Classification, at least one measurable lesion(LDi≥1.5 cm)
- r/r DLBCL patients who received prior CD19 CAR-T therapy, and positive for CD20
- At least 2 weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis
- Adequate organ and bone marrow fuction
- 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 inhibitors
- 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 peripheral blood 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 :
September 29 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 8 2023
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT04316624
Start Date
September 29 2019
End Date
February 8 2023
Last Update
July 19 2023
Active Locations (1)
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1
Institute of Hematology & Blood Diseases Hospital
Tianjin, China, 300020