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Universal CAR-γδT Cell Injection in the AML Patients

Sponsor
Hebei Senlang Biotechnology Inc., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05388305
Collaborator
(none)
30
Enrollment
1
Location
1
Arm
13.3
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: CAR--γδT cells
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Study of Universal CAR-γδT Cell Injection in the Treatment of Refractory and Relapsed AML Patients
Actual Study Start Date :
Apr 20, 2022
Anticipated Primary Completion Date :
Apr 30, 2023
Anticipated Study Completion Date :
May 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: CAR--γδT

Biological: CAR--γδT cells
Biological: CAR-γδT; Drug:

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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;
  2. 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;

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tongji Hospital Wuhan Hubei China

Sponsors and Collaborators

  • Hebei Senlang Biotechnology Inc., Ltd.

Investigators

  • Principal Investigator: Liang Huang, PhD, Tongji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hebei Senlang Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier:
NCT05388305
Other Study ID Numbers:
  • CAR-γδT for AML
First Posted:
May 24, 2022
Last Update Posted:
May 26, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of May 26, 2022