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
Study ID
NCT07539688
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • CY-219 CAR-T — DRUG
    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.

Study Details

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 Dates

First listed
Apr 20, 2026
Start date
May 1, 2026
Status verified
Apr 2026
Primary completion
Mar 1, 2029
Completion
Dec 1, 2029

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: CY-219 CAR-T

Primary Outcome Measure

Safety indicators [ Time Frame: 6 months after CAR-T infusion ]

Central Contacts

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