NCT04666168

A Multicenter Clinical Study on the Safety and Efficacy of CAR-T in the Treatment of Relapsed / Refractory Non Hodgkin's Lymphoma

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. · Industry
• Sex: All
• Age: 14 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, non randomized, single arm, open clinical trial. The selected disease was relapsed / refractory NHL, and the disease was classified into highly aggressive lymphoma, invasive lymphoma and inert lymphoma; Highly invasive NHL included Burkitt lymphoma (BL), lymphoblastic lymphoma (LBL), high-grade B-cell lymphoma, etc; Invasive NHL includes diffuse large B-cell lymphoma, mantle cell lymphoma and peripheral T-cell lymphoma; Inert NHL contains follicular lymphoma, small lymphocytic lymphoma and marginal zone lymphoma.

Detailed description

A single car consists of scFv, hinge region, transmembrane region, costimulatory domain and zeta subunit of CD3.Prior to CAR-T cell infusion, the patients will be subjected to preconditioning treatment. After CAR-T cell infusion, the patients will be evaluated for adverse reactions and efficacy.

Conditions

• Non-hodgkin's Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Auto CAR-T	Biological: Auto CAR-T
DRUG	Cyclophosphamide,Fludarabine	Drug: Cyclophosphamide,Fludarabine
PROCEDURE	Leukapheresis	Leukapheresis

Timeline

• Start date: 2020-10-22
• Primary completion: 2023-10-21
• Completion: 2025-10-21
• First posted: 2020-12-14
• Last updated: 2020-12-14

Locations

1 site across 1 country: China