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

NCT04785833 | Unknown

• 1 other identifier: PA-CART-3-17-001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

T-ALL

Outcome Measures

Primary Outcomes (1)

• DLT

  Dose-limiting toxicity

  Up to 2 years

Secondary Outcomes (3)

• Safety results

  Up to 2 years

• PK

  Up to 2 years

• PD

  Up to 2 years

Study Arms (1)

T cell injection targeting CD7 chimeric antigen receptor

EXPERIMENTAL

Drug: T cell injection targeting CD7 chimeric antigen receptor

Interventions

T cell injection targeting CD7 chimeric antigen receptor DRUG

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

T cell injection targeting CD7 chimeric antigen receptor

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The First Affiliared Hospital Of SOOCHOW University

Suzhou, Jiangsu, 215006, China

RECRUITING

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

xiaowen tang

CONTACT

13913538266; xwtang1020@163.com

huimin meng

CONTACT

18896802149; huimin.meng@persongen.com.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2021
• First Posted: March 8, 2021
• Study Start: March 4, 2021
• Primary Completion: April 30, 2022
• Study Completion: February 4, 2024
• Last Updated: March 8, 2021

Record last verified: 2021-03

Locations

CN (1)