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

NCT04973527 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2022-08-16

No results posted yet for this study

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.

Conditions

  • T Cell Lymphoma
  • T-cell Leukemia

Interventions

DRUG

Efficacy of LCAR-T2C CAR-T cells

CD4-directed CAR-T cells administered with lymphoid depletion, and to obtain the preliminary efficacy results in subjects who have been diagnosed with relapsed or refractory CD4 positive T lymphocyte tumor

Sponsors & Collaborators

  • Nanjing Legend Biotech Co.

    collaborator INDUSTRY

  • Beijing Boren Hospital

    lead OTHER

Principal Investigators

  • Kai Hu, MD/PhD · Beijing Boren Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-02
Primary Completion
2022-07-11
Completion
2022-07-20

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04973527 on ClinicalTrials.gov