This study is an open-label, single-arm, prospective clinical trial involving patients with relapsed/refractory B-cell lymphoma, aimed at evaluating the safety and efficacy of CAR-T cell infusion.
1. The participant has given consent and signed the informed consent form, and is willing and able to comply with the planned visits, research treatments, laboratory tests, and other trial procedures;
Anti-CD20 monoclonal antibody;
Combination chemotherapy containing anthracyclines.
3. Age 18 or older, both men and women are eligible;
1. Severe heart failure or left ventricular ejection fraction <50%;
2. History of severe pulmonary function impairment;
3. Concurrent other malignant tumors in the progressive stage;
4. Concurrent severe infection that cannot be effectively controlled;
Single group
CY-219 CAR-T
DrugEligible participants should receive preconditioning 5 to 3 days before CAR-T cell infusion. The recommended preconditioning regimen is fludarabine (30 mg/m²/day, for 3 consecutive days) and cyclophosphamide (300 mg/m²/day, for 3 consecutive days) (Flu/Cy). Thirty minutes before infusion, prophylactic medication for allergic reactions should be administered: 25 mg of promethazine hydrochloride or 12.5 mg of diphenhydramine, either intramuscularly or orally. A '3+3' dose-escalation study design will be used, aiming to recruit 9-18 subjects with relapsed/refractory B-cell lymphoma.
Safety indicators
Six months after CAR-T infusion, analyze the recorded possible adverse reactions, mainly including the number of cases, incidence, and severity of immune-related toxicities such as cytokine release syndrome, immune effector cell-associated neurotoxicity, hematologic toxicity, and organ toxicity. The incidence of DLT.
Efficacy indicators
Tumor objective response rate (ORR) at 3 months follow-up after treatment.
Efficacy indicators
Complete remission (CR) rate at 3 months post-treatment follow-up
Efficacy indicators
Overall survival (OS) at 3 months post-treatment follow-up
Efficacy indicators
Progression-free survival (PFS) at 3 months after treatment follow-up
CAR-T single-cell phenotype and clonal characteristics
CY-219 CAR-T cell infusion product and the in vivo CAR-T single-cell phenotype, clonal characteristics of research participants, as well as other indicators of interest to researchers, such as cytokine profiles.
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This trial is not recruiting at the moment. You can still explore other options:
