Universal CAR-γδT Cell Injection in the AML Patients

NCT ID: NCT05388305

Last Updated: 2022-05-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-20
• Study Completion Date: 2023-05-30

Brief Summary

To evaluate the safety of general-purpose CAR-γδT cells in patients with refractory post-transplant relapsed AML.

Detailed Description

To evaluate the efficacy and in vivo dynamics of general-purpose CAR-γδT cells in the treatment of refractory relapsed AML patients, and to explore the appropriate therapeutic dose and delivery mode.

Conditions

AML

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CAR--γδT

Group Type: EXPERIMENTAL

CAR--γδT cells

Intervention Type: BIOLOGICAL

Biological: CAR-γδT; Drug:

Interventions

CAR--γδT cells

Biological: CAR-γδT; Drug:

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• The clinical diagnosis was difficult to treat recurrent acute myeloid leukemia；
• Flow cytometry (FCM) or immunohistochemistry of tumor~ cells confirmed positive expression of CD123；
• 18 years old ≤ age ≤70 years old;
• The expected survival from the date of informed consent is more than 3 months;
• ECOG≤2;
• The functions of vital organs shall meet the following conditions:

1) EF>50%, and no obvious ECG abnormality; 2) SpO2 90% or more; 3) Cr 2.5 ULN or less; 4) ALT And AST≤5ULN, TBil≤3ULN;

• Subjects who plan to become pregnant must agree before study enrollment and after study duration of 6 months Use contraception; Inform the investigator immediately if the subject is pregnant or suspected to be pregnant;
• Subject or guardian understands and signs the informed consent.

Exclusion Criteria

• Other diseases that have not been effectively controlled, including but not limited to persistent or poorly controlled infections and diseases Congestive heart failure, unstable angina pectoris, arrhythmias, poorly controlled lung disease Or mental illness;
• Other active malignant tumors;
• Complicated with severe infection that cannot be effectively controlled;
• Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive, peripheral blood hepatitis B virus (HBV)DNA higher than the detection limit should be excluded; If hepatitis C virus (HCV) antibody positive, peripheral blood HCV RNA positive need to be eliminated; Cytomegalovirus (CMV)DNA positive; Epstein-barr virus DNA in peripheral blood was positive;
• Human immunodeficiency virus (HIV) infection or syphilis infection;
• Have a history of severe allergy to biological products (including antibiotics);
• Acute graft-versus-host reaction (GVHD) was still present one month after discontinuation of immunosuppressant therapy Allogeneic hematopoietic stem cell transplantation patients;
• Female subjects are in pregnancy and lactation;
• Active autoimmune diseases requiring systemic immunosuppression;
• Conditions that the investigator believes may increase the risk of the subject or interfere with the results of the test;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Senlang Biotechnology Inc., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Liang Huang, PhD

Role: PRINCIPAL_INVESTIGATOR

Tongji Hospital

Locations

Tongji Hospital

Wuhan, Hubei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Liang Huang, PhD

Role: CONTACT

027-83665555

Jianqiang Li, PhD

Role: CONTACT

limmune@gmail.com

008615511369555

Facility Contacts

Liang Huang, PhD&MD

Role: primary

Other Identifiers

CAR-γδT for AML

Identifier Type: -

Identifier Source: org_study_id