Clinical trial NCT05388305: Universal CAR-γδT Cell Injection in the AML Patients
Official title: Clinical Study of Universal CAR-γδT Cell Injection in the Treatment of Refractory and Relapsed AML Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: AML
Lead sponsor: Hebei Senlang Biotechnology Inc., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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; 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.

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;

Primary outcomes:
measure: Safety: Incidence and severity of adverse events
timeFrame: First 1 month post CAR-T cells infusion
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Liang Huang, PhD
role: PRINCIPAL_INVESTIGATOR
References: