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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

NCT07539688 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-20

No results posted yet for this study

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.

Conditions

  • Relapsed/Refractory B-cell Lymphoma
  • Diffuse Large B-cell Lymphoma
  • Inert B-cell Lymphoma Transformed Into Large B-cell Lymphoma (Excluding Richter Transformation, THRLBCL, and BL)

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.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2029-03-01
Completion
2029-12-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07539688 on ClinicalTrials.gov