Universal CAR-γδT Cell Injection in the AML Patients

Not Applicable

• Conditions: AML
• Interventions: Biological: CAR--γδT cells

• Registration Number: NCT05388305
• Lead Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

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.

Study Timeline

• Study Start: 2022-04-20
• Status Verified: 2022-05
• Study First Submitted: 2022-05-19
• Study First Submitted QC: 2022-05-19
• Study First Posted: 2022-05-24
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-26
• Primary Completion: 2023-04-30
• Study Completion: 2023-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CAR--γδT	CAR--γδT cells	-

Primary Outcome Measures

Name	Time	Method
Safety: Incidence and severity of adverse events	First 1 month post CAR-T cells infusion	To evaluate the possible adverse events occurred within first one month after CAR-γδT infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity

Trial Locations

Locations (1)

Tongji Hospital; 🇨🇳 Wuhan, Hubei, China