NCT07447726

Exploratory Clinical Study on the Safety and Efficacy of CD19X CAR-T Cell Injection in the Treatment of Relapsed/Refractory Large B-Cell Lymphoma

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 3 (estimated)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is an open-label, single-arm, prospective, exploratory clinical trial involving patients with relapsed/refractory large B-cell lymphoma, aiming to preliminarily assess the safety and efficacy of CAR-T cell infusion.

Detailed description

This study is an open-label, single-arm, prospective, exploratory clinical trial targeting patients with relapsed/refractory large B-cell lymphoma. It plans to enroll 3 participants, where the investigator will administer a dose of 1-2×10\^6 CAR cells/kg of CAR-T cell infusion and follow up to observe related data on post-treatment adverse reactions and therapeutic effects, with the aim of preliminarily evaluating the safety and efficacy of the CAR-T cell infusion.

Conditions

• Large B-Cell Lymphoma (LBCL)

Interventions

Type	Name	Description
DRUG	CD19X CAR-T	Eligible participants receive lymphodepletion pretreatment 3 to 5 days before the therapy. The recommended pretreatment regimen is fludarabine (25-30 mg/m²) and cyclophosphamide (250-300 mg/m²). Antihistamines are administered before infusion. The plan is to enroll 3 patients with relapsed/refractory large B-cell lymphoma, who will be evaluated by the investigator and treated with 1-2 × 10\^6 CAR cells/kg of CAR-T cell infusion.

Timeline

• Start date: 2026-04-05
• Primary completion: 2028-01-01
• Completion: 2028-01-01
• First posted: 2026-03-03
• Last updated: 2026-03-03