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Spots Global Cancer Trial Database for LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T Lymphocyte Tumor

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Trial Identification

Brief Title: LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T Lymphocyte Tumor

Official Title: A Phase I, Multicenter Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T Lymphocyte Tumor Patients

Study ID: NCT04973527

Study Description

Brief Summary: This is a multicenter phase I clinical study evaluating the safety, tolerability, and efficacy of LCAR-T2C cell agents targeting CD4 in patients with relapsed/refractory CD4-positive T lymphocytic tumors. Thirty-three subjects will be enrolled. Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 5 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 300 mg/m2( body surface area) for 3 days. hen this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 to dose 2 (dl-2): 1.5×106 , to dose 3 (dl-3): 5×106 to dose 4 (dl-4): 10.0×106. Below the lowest dose was reinfused at the PI's discretion.

Detailed Description: This is an open, dose escalation/dose extension study of LCAR-T2C CAR-T cells administered to patients with T lymphocyte tumor. The aim of the study is to evaluate the safety, tolerability, and efficacy of LCAR-T2C CAR-T cells. The auto-CAR-T cells will be infused in single-dose.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Beijing Boren Hospital, Beijing, Beijing, China

Beijing Boren Hospital, Beijing, Beijing, China

Contact Details

Name: Kai Hu, MD/PhD

Affiliation: Beijing Boren Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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