Study of LUCAR-20S in Patients With R/R NHL

Status Recruiting

Clinical Trial Summary

An open label, single arm Phase I study to evaluate the safety, tolerability, and pharmacokinetics of LUCAR-20S CAR-T cells in relapsed or refractory CD20+ diffuse large B-cell, follicular, mantle cell and small lymphocytic lymphoma.

Clinical Trial Description

This study is an open, dose escalation/dose regimen finding study to assess the safety and pharmacokinetics of donor-derived CD20-directed CAR-T cells administered with lymphodepletion, and to obtain the preliminary efficacy results in subjects who have been diagnosed with relapsed or refractory CD20 positive diffuse large B-cell lymphoma, follicular lymphoma, mantle cell lymphoma or small lymphocytic lymphoma. The allo-CAR-T cells will be infused in single-dose. Using an accelerated titration design combined with BOIN design using live CAR-positive T cells at a starting dose of 0.17×106/kg(range 0.12 to 0.22×106/kg), 6 dose groups [0.17×106/kg(range 0.12~0.22×106/kg), 30×106, 90×106, 300×106, 600×106 and 900×106 live CAR positive T cells were evaluated to determine MTD or RP2D for LUCAR-20S cells. In the medium group, 0.17×106/kg(range 0.12~0.22×106/kg), 30×106, 90×106 live CAR positive T cells; The BOIN phase dose group consisted of 300×106, 600×106 and 900×106 live CAR positive T cells. To avoid exposing more subjects to the invalid dose group, DLT was first explored by accelerated titration after the trial began. There were about 24 subjects at this stage. In the dose expansion phase, more subjects were enrolled at established MTD or RP2D doses to further evaluate the safety, tolerability, and anti-tumor efficacy of LUCAR-20S cell therapy at these doses. About 10 subjects were enrolled at this stage. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04994587
Study type	Interventional
Source	Beijing Boren Hospital
Contact	Kai Hu, MD/PhD
Phone	+8615010390336
Email	xiaohu7079@sina.com
Status	Recruiting
Phase	Phase 1
Start date	December 1, 2020
Completion date	January 21, 2023

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