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

NCT04796441 | Unknown

• 1 other identifier: CAR-γδT cell for AML
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Conditions

AML

Keywords

AML γδT CAR-

Outcome Measures

Primary Outcomes (2)

• 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

• Efficacy: Remission Rate

  Remission Rate including complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR)

  3 months post CAR-T cells infusion

Secondary Outcomes (4)

• duration of response (DOR)

  24 months post CAR-T cells infusion

• Efficacy: progression-free survival (PFS)

  24 months post CAR-T cells infusion

• CAR-T proliferation

  3 months post CAR-T cells infusion

• Cytokine release

  First 1 month post CAR-T cells infusion

Study Arms (1)

CAR--γδT

EXPERIMENTAL

Patients will be treated with CAR--γδT cells

Biological: CAR-γδT

Interventions

CAR-γδT BIOLOGICAL

Biological: CAR-γδT; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;

Also known as: CD19 CAR-T

CAR--γδT

Eligibility Criteria

• Age: 2 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

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; 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;

Sponsors & Collaborators

• Hebei Senlang Biotechnology Inc., Ltd.: lead

Study Sites (1)

Hebei yanda Ludaopei Hospital

Yanda, Hebei, China

RECRUITING

Study Officials

• Peihua MD Lu, PhD

  Hebei Yanda Ludaopei Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peihua MD Lu, PhD

CONTACT

008618611636172; peihua_lu@126.com

Jianqiang MD 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: March 8, 2021
• First Posted: March 12, 2021
• Study Start: December 16, 2020
• Primary Completion: December 16, 2021
• Study Completion: February 16, 2022
• Last Updated: March 12, 2021

Record last verified: 2021-03

Locations

CN (1)