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

T-ALL Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04785833
• Other study ID #: PA-CART-3-17-001
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2021
• Est. completion date: February 4, 2024

Study information

• Verified date: March 2021
• Source: PersonGen BioTherapeutics (Suzhou) Co., Ltd.
• Contact: xiaowen tang
• Phone: 13913538266
• Email: xwtang1020[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 4, 2024
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Leukemia
• T-ALL

Intervention

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

Locations

Country	Name	City	State
China	The First Affiliared Hospital Of SOOCHOW University	Suzhou	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
PersonGen BioTherapeutics (Suzhou) Co., Ltd.	The First Affiliated Hospital of Soochow University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLT	Dose-limiting toxicity	Up to 2 years
Secondary	Safety results	Number of adverse events	Up to 2 years
Secondary	PK	The maximum concentration (Cmax)	Up to 2 years
Secondary	PD	Absolute value of CD7 Positive Cells in peripheral blood at each time point	Up to 2 years