Universal CAR-γδT Cell Injection in the AML Patients

NCT05388305 | Unknown

• 1 other identifier: CAR-γδT for AML
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

AML

Outcome Measures

Primary Outcomes (1)

• Safety: Incidence and severity of adverse events

  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

  First 1 month post CAR-T cells infusion

Study Arms (1)

CAR--γδT

EXPERIMENTAL

Biological: CAR--γδT cells

Interventions

CAR--γδT cells BIOLOGICAL

Biological: CAR-γδT; Drug:

CAR--γδT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The clinical diagnosis was difficult to treat recurrent acute myeloid leukemia；
• Flow cytometry (FCM) or immunohistochemistry of tumor\~ cells confirmed positive expression of CD123；
• 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:
• \) 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, China

RECRUITING

Study Officials

• Liang Huang, PhD

  Tongji Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Liang Huang, PhD

CONTACT

027-83665555

Jianqiang Li, PhD

CONTACT

008615511369555; limmune@gmail.com

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: May 19, 2022
• First Posted: May 24, 2022
• Study Start: April 20, 2022
• Primary Completion: April 30, 2023
• Study Completion: May 30, 2023
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)