MedTrace Logo

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

NCT04480788 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2021-01-06

No results posted yet for this study

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

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

Sponsors & Collaborators

  • The First Affiliated Hospital of Zhengzhou University

    collaborator OTHER

  • PersonGen BioTherapeutics (Suzhou) Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-24
Primary Completion
2022-08-01
Completion
2022-08-31

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 NCT04480788 on ClinicalTrials.gov