Status and phase
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About
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.
Full 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 include the following sequential phases: Screening, Pre- Treatment (Cell Product Preparation, Lymphodepleting Chemotherapy), C-CAR066 infusion and Follow-up Visit.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
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:
The investigators believe that there are other circumstances that are not suitable for the trial
Primary purpose
Allocation
Interventional model
Masking
13 participants in 1 patient group
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Central trial contact
Aibin Liang, MD,Ph.D.; Ping Li, MD,Ph.D.
Data sourced from clinicaltrials.gov
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