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Clinical Study of Universal CAR-γδT Cell Injection in the Treatment of Patients With Relapsed AML After Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04796441
Recruitment Status : Recruiting
First Posted : March 12, 2021
Last Update Posted : March 12, 2021
Sponsor:
Information provided by (Responsible Party):
Hebei Senlang Biotechnology Inc., Ltd.

Study Description
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Brief Summary:
This is an open single-arm clinical study aimed at evaluating the efficacy and safety of universal γδT cell injection in the treatment of patients with relapsed AML after transplantation

Condition or disease Intervention/treatment Phase
AML Biological: CAR-γδT Not Applicable

Detailed Description:

Main purpose: To evaluate the safety and effectiveness of universal CAR-γδT cell injection in the treatment of patients with relapsed AML after transplantation

Secondary purpose: to investigate the in vivo dynamics characteristics of universal CAR-γδT cells after infusion and explore reasonable therapeutic doses through climbing tests in different dose groups.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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 Patients With Relapsed AML After Transplantation
Actual Study Start Date : December 16, 2020
Estimated Primary Completion Date : December 16, 2021
Estimated Study Completion Date : February 16, 2022
Arms and Interventions
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Arm Intervention/treatment
Experimental: CAR--γδT
Patients will be treated with CAR--γδT cells
 Biological: CAR-γδT
Biological: CAR-γδT; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;
Other Name: CD19 CAR-T


Outcome Measures
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Primary Outcome Measures :
  1. Safety: Incidence and severity of adverse events [ Time Frame: 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

  2. Efficacy: Remission Rate [ Time Frame: 3 months post CAR-T cells infusion ]
    Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)


Secondary Outcome Measures :
  1. duration of response (DOR) [ Time Frame: 24 months post CAR-T cells infusion ]
    duration of response (DOR)

  2. Efficacy: progression-free survival (PFS) [ Time Frame: 24 months post CAR-T cells infusion ]
    progression-free survival (PFS) time

  3. CAR-T proliferation [ Time Frame: 3 months post CAR-T cells infusion ]
    the copy number of CAR- γδT cells in the genomes of PBMC by qPCR method

  4. Cytokine release [ Time Frame: First 1 month post CAR-T cells infusion ]
    Cytokine( IL-6,IL-10,IFN-γ,TNF-α ) concentration (pg/mL) by flow cytometry method


Eligibility Criteria
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Ages Eligible for Study:   2 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with clinically diagnosed recurrence of AML after receiving transplant therapy;
  2. Flow cytometry (FCM) or immunohistochemical detection of tumor cells confirmed CD123 positive;
  3. Age ≥2 years old and <65 years old;
  4. Survival is expected to be greater than 3 months from the date of signing of the informed consent;
  5. KPS 80 points or more;
  6. 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; 7. 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; 8. Subject or guardian understands and signs the informed consent;

Exclusion Criteria:

  • 1. 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; 2. Other active malignant tumors; 3. Complicated with severe infection that cannot be effectively controlled; 4. Active hepatitis B (HBVDNA) or HCV RNA [HCVRNA] test was positive); 5. Human immunodeficiency virus (HIV) infection or syphilis infection; 6. Have a history of severe allergy to biological products (including antibiotics); 7. Acute graft-versus-host reaction (GVHD) was still present one month after discontinuation of immunosuppressant therapy Allogeneic hematopoietic stem cell transplantation patients; 8. Female subjects are in pregnancy and lactation; 9. Active autoimmune diseases requiring systemic immunosuppression; 10. Conditions that the investigator believes may increase the risk of the subject or interfere with the results of the test;
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04796441


Contacts
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Contact: Peihua MD Lu, PhD 008618611636172 peihua_lu@126.com
Contact: Jianqiang MD Li, PhD 008615511369555 limmune@gmail.com

Locations
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China, Hebei
Hebei yanda Ludaopei Hospital Recruiting
Yanda, Hebei, China
Contact: Peihua MD Lu, PhD    008618611636172    peihua_lu@126.com   
Sponsors and Collaborators
Hebei Senlang Biotechnology Inc., Ltd.
Investigators
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Principal Investigator: Peihua MD Lu, PhD Hebei Yanda Ludaopei Hospital
More Information
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Responsible Party: Hebei Senlang Biotechnology Inc., Ltd.
ClinicalTrials.gov Identifier: NCT04796441    
Other Study ID Numbers: CAR-γδT cell for AML
First Posted: March 12, 2021    Key Record Dates
Last Update Posted: March 12, 2021
Last Verified: March 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hebei Senlang Biotechnology Inc., Ltd.:
AML γδT CAR-