NCT04219319

LCAR-T2C CAR-T Cells in Relapsed or Refractory CD4+ T-cell Lymphoma

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 Patiens

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This is an open, dose escalation/dose extension study of LCAR-T2C CAR-T cells administrered 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.

Conditions

• CD4+ T Lymphocyte Tumor (T Cell Lymphoma and T Cell Leukemia)

Interventions

Type	Name	Description
DRUG	Efficacy of LCAR-T2C CAR-T cells	CD4-directed CAR-T cells administered with lymphodepletion, and to obtain the preliminary efficacy results in subjects who have been diagnosed with relapsed or refractory CD4 positive T lymphocyte tumor

Timeline

• Start date: 2021-12-15
• Primary completion: 2022-07-20
• Completion: 2022-07-20
• First posted: 2020-01-07
• Last updated: 2022-08-16

Locations

3 sites across 1 country: China