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

AML Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04796441
• Other study ID #: CAR-?dT cell for AML
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2020
• Est. completion date: February 16, 2022

Study information

• Verified date: March 2021
• Source: Hebei Senlang Biotechnology Inc., Ltd.
• Contact: Peihua MD Lu, PhD
• Phone: 008618611636172
• Email: peihua_lu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: February 16, 2022
• Est. primary completion date: December 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 65 Years

Eligibility

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;

Related Conditions & MeSH terms

• AML

Intervention

Biological:
• CAR-?dT
Biological: CAR-?dT; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;

Locations

Country	Name	City	State
China	Hebei yanda Ludaopei Hospital	Yanda	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Senlang Biotechnology Inc., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Incidence and severity of adverse events	To evaluate the possible adverse events occurred within first one month after CAR-?dT infusion, including the incidence and severity of symptoms such as cytokine release syndrome and neurotoxicity	First 1 month post CAR-T cells infusion
Primary	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	duration of response (DOR)	duration of response (DOR)	24 months post CAR-T cells infusion
Secondary	Efficacy: progression-free survival (PFS)	progression-free survival (PFS) time	24 months post CAR-T cells infusion
Secondary	CAR-T proliferation	the copy number of CAR- ?dT cells in the genomes of PBMC by qPCR method	3 months post CAR-T cells infusion
Secondary	Cytokine release	Cytokine( IL-6,IL-10,IFN-?,TNF-a ) concentration (pg/mL) by flow cytometry method	First 1 month post CAR-T cells infusion