NCT04480788

CD7-CART in the Treatment of r / r CD7 Positive Hemolymph System Malignancies on Increasing Dose and Open Label Study

Early Clinical Study on Increasing Dose and Open Label of T Cell Injection Targeting CD7 Autologous Chimeric Antigen Receptor in the Treatment of Relapsed / Refractory CD7 Positive Hemolymph System Malignancies

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 9 (estimated)
• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd. · Industry
• Sex: All
• Age: 7 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

Phase I was a single arm, open label, dose increasing study to explore the safety, tolerance and Cytodynamic characteristics of the drug, and to preliminarily observe the efficacy of the study drug in relapsed / refractory CD7 Positive hematolymph system malignant tumor patients, so as to explore the clinical applicable dose of phase II. Since the activity and toxicity of cellular drugs (long-term survival drugs) do not have obvious dose dependence, and the increase of their dose may be accompanied by the increase of toxicity, rather than necessary for therapeutic effect, it is not necessarily suitable to recommend the effective dose according to the maximum tolerable dose (MTD). Therefore, this study will be based on the safety data, as well as the preliminary efficacy, efficacy and drug The end point of pharmacokinetics (ORR, the content of CD7 Positive Cells, the expansion and duration of car-t cells) were comprehensively considered to determine the recommended dose for phase II clinical trial.Main research purposes Objective to evaluate the safety and tolerability of T cell injection targeting CD7 autologous chimeric antigen receptor in the treatment of relapsed / refractory CD7 Positive hematological and lymphoid malignancies.

Conditions

• T Lymphoblastic Leukemia/Lymphoma
• Extramedullary NK-T-cell Lymphoma, Nasal Type
• Peripheral T-cell Lymphoma, Nonspecific
• Angioimmunoblastic T-cell Lymphoma
• Enteropathy-Associated T-Cell Lymphoma
• Anaplastic Large Cell Lymphoma, ALK-negative
• T-cell Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	T cell injection targeting CD7 chimeric antigen receptor	Drug name: T cell injection targeting CD7 autologous chimeric antigen receptor. Package specification: 10-50ml bag, 1-4 bags / person, which is determined according to the body weight of the subject and the effective content of cell preparation

Timeline

• Start date: 2020-11-24
• Primary completion: 2022-08-01
• Completion: 2022-08-31
• First posted: 2020-07-21
• Last updated: 2021-01-06

Locations

1 site across 1 country: China