CD123+CLL-1 CAR-T Sequential Infusion With CD7 CAR-T and Bridging to Allo-HSCT for Relapsed/Refra… (NCT07201727) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
CD123+CLL-1 CAR-T Sequential Infusion With CD7 CAR-T and Bridging to Allo-HSCT for Relapsed/Refractory Acute Myeloid Leukemia
10 participantsStarted 2025-09-30
Plain-language summary
This study is a single-arm, open-label, prospective clinical trial, with patients suffering from refractory and relapsed acute myeloid leukemia as the subjects. It plans to enroll 10 cases to evaluate the safety and efficacy of sequential CD123+CLL-1 CAR-T cells followed by CD7 CAR-T cells treatment.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
Patients must meet all of the following criteria:
* Patients are clinically diagnosed with relapsed or refractory acute myeloid leukemiaï¼›
* Tumor cells are confirmed to be CD123 or CLL-1 positive by flow cytometry (FCM) or immunohistochemistry, with a positivity rate of no less than 80%ï¼›
* Patients aged 18 to 75 years (inclusive)ï¼›
* The expected survival time is more than 3 months from the date of signing the informed consent;
* KPS≥80 points;
* The functions of vital organs need to meet the following conditions: ①LVEF\>50%,and electrocardiogram is normal; ② Oxygen saturation ≥90%;③ SCr≤2.5ULN;④ALT and AST≤5ULN,TBil≤3ULN;
* Subjects intending to conceive must agree to use contraception prior to study enrollment and for six months post-study. In the event of pregnancy or suspected pregnancy, they should promptly notify the investigator.
* The subject or guardian understands and signs the Informed Consent Form (ICF).
Exclusion Criteria:
Any of the following conditions will not be eligible for enrolment in this study:
* Within one - year prior to signing the informed consent form, there is a history of heart failure of New York Heart Association (NYHA) class ≥ III, or myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris, or other cardiac diseases with prominent clinical symptoms, or the QTc interval is \> 480 ms during screening (the QTc interval is calculated by the Fridericia formula);
* Those with active GvHD or t…
What they're measuring
1
Monitor and record adverse events
Timeframe: From CAR - T cell infusion to 2 years later.
Trial details
NCT IDNCT07201727
SponsorInstitute of Hematology & Blood Diseases Hospital, China