CD7 CAR-T in the Treatment of CD7 Positive Refractory Relapsed Acute Leukemia

A Prospective, Open, Single-arm Clinical Study on the Efficacy and Safety of CD7 CAR-T in the Treatment of CD7-positive Refractory Relapsed Acute Leukemia

Patients with acute leukemia derived from T lymphocytes have the characteristics of high expression of CD7 antigen, such as acute T lymphocyte leukemia (T-ALL).CAR-T therapy is to genetically modify the patient's T lymphocytes to target and eliminate tumor cells in a major histocompatibility complex-independent manner. CAR-T cells are costimulatory molecules that include single-chain antibodies (scFv) that recognize tumor-specific antigens, hinge regions, transmembrane regions, intracellular signaling regions (immunoreceptor tyrosine activation motif ITAM), and intracellular signaling regions. The chimeric antigen receptor of CD28 or CD137(4-1BB) conduction domain is expressed in a lentiviral vector, and the vector is transfected into autologous T cells, so that the modified CAR-T cells have targeting and specificity Recognizes and kills cancer cells expressing tumor antigens, and can proliferate and activate in vivo, but has no effect on cells that do not express the antigen

Study Overview

• Status: Recruiting
• Conditions: T-ALL
• Intervention / Treatment: Drug: T cell injection targeting CD7 chimeric antigen receptor

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: xiaowen tang; Phone Number: 13913538266; Email: xwtang1020@163.com
• Study Contact Backup: Name: huimin meng; Phone Number: 18896802149; Email: huimin.meng@persongen.com.cn

Study Locations

• China
  • Jiangsu
    • Suzhou, Jiangsu, China, 215006
      • Recruiting
      • The First Affiliared Hospital Of SOOCHOW University
      • Contact: xiaowen tang; Phone Number: 13913538266; Email: xwtang1020@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 12-65
• Sign informed consent
• Expected survival time ≥ 3 months
• CD7 positive refractory and relapsed acute leukemia
• Karnofsky score≥60
• ECOG score ≤ 2
• Have not received other immunotherapy within 3 months
• The CD7 expression rate on the surface of leukemia cells detected by flow cytometry is greater than 30%

Exclusion Criteria:

• Uncontrolled active infection
• Active viral hepatitis B or C
• HIV test positive
• Congenital immunodeficiency patients
• Pregnant and breastfeeding patients
• Patients with central nervous system tumors or central nervous system leukemia
• The patient and/or family members do not agree to the treatment plan

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: T cell injection targeting CD7 chimeric antigen receptor	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DLT	Dose-limiting toxicity	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety results	Number of adverse events	Up to 2 years
PK	The maximum concentration (Cmax）	Up to 2 years
PD	Absolute value of CD7 Positive Cells in peripheral blood at each time point	Up to 2 years

Collaborators and Investigators

• Sponsor: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
• Collaborators: The First Affiliated Hospital of Soochow University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 4, 2021
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): February 4, 2024

Study Registration Dates

• First Submitted: March 3, 2021
• First Submitted That Met QC Criteria: March 3, 2021
• First Posted (Actual): March 8, 2021

Study Record Updates

• Last Update Posted (Actual): March 8, 2021
• Last Update Submitted That Met QC Criteria: March 3, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Leukemia
• Other Study ID Numbers: PA-CART-3-17-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No