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NOT YET RECRUITING
NCT07539688
PHASE1

Phase I Clinical Study on the Safety and Efficacy of CY-219 CAR-T Cell Injection in the Treatment of Relapsed/Refractory B-Cell Lymphoma

Sponsor: Institute of Hematology & Blood Diseases Hospital, China

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2026-05-01

Completion Date

2029-12-01

Last Updated

2026-04-20

Healthy Volunteers

No

Interventions

DRUG

CY-219 CAR-T

Eligible 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.