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NOT YET RECRUITING
NCT07809139
PHASE1

A Clinical Study to Evaluate CHT101 Injection in Subjects With Relapsed/Refractory T-Cell and B-Cell Hematologic Malignancies

Sponsor: Nanjing Miracle Biotechnology Co., Ltd.

View on ClinicalTrials.gov

Summary

Primary Objective: To evaluate the safety, tolerability, and dose-limiting toxicity of anti-CD70 chimeric antigen receptor allogeneic T-cell injection (CHT101) in the treatment of CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies. Secondary Objectives: To characterize the PK profiles of CHT101; to evaluate the clinical efficacy of CHT101 for CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies. Indication: CD70-positive relapsed/refractory T-cell and B-cell hematological malignancies

Official title: A Phase I, Single-Arm, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of CHT101 Injection in Subjects With Relapsed/Refractory T-Cell and B-Cell Hematological Malignancies

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-09

Completion Date

2028-12

Last Updated

2026-09-09

Healthy Volunteers

No

Interventions

DRUG

CHT101

Single-dose and multiple-dose administration Method of Administration: Intravenous infusion Dose of Administration:3.6\*10\^9 CAR-T cells,7.2\*10\^9 CAR-T cells,10\*10\^9 CAR-T cells.

Locations (1)

Jiangxi Cancer Hospital

Nanchang, Jiangxi, China