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Testing a new CAR T cell therapy for acute myeloid leukemia

A Phase I Study of ADCLEC.syn1 CAR T Cells in Adult Patients With Relapsed or Refractory Acute Myeloid Leukemia

Phase 1 Interventional Memorial Sloan Kettering Cancer Center · NCT05748197

This study is testing a new CAR T cell therapy to see if it can safely help adults with relapsed or hard-to-treat acute myeloid leukemia.

Quick facts

PhasePhase 1
Study typeInterventional
Enrollment40 (estimated)
Ages18 Years and up
SexAll
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionsCAR T, chemotherapy, prednisone
Locations7 sites (Basking Ridge, New Jersey and 6 other locations)
Trial IDNCT05748197 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety of ADCLEC.syn1 CAR T cells in adults with relapsed or refractory acute myeloid leukemia (AML). Researchers will determine the highest dose of these CAR T cells that results in few or mild side effects. Once the optimal dose is established, it will be tested for effectiveness in treating participants' AML. The study involves conditioning chemotherapy prior to the administration of the CAR T cells.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with relapsed or refractory AML who have a suitable stem cell donor.

Not a fit: Patients with AML who are not relapsed or refractory, or those with an ECOG performance status greater than 1, may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat AML.

How similar studies have performed: Other studies using CAR T cell therapies have shown promise in treating various hematologic malignancies, indicating potential success for this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age ≥18 years of age at the time of signing informed consent.
2. Patients must have R/R AML. The following disease status will be eligible for the study:

   a. Refractory AML is defined as failure to achieve a CR, CRh or CRi after one of the following regimens: i. At least one course of standard intensive induction chemotherapy (e.g., 7+3, MEC, HiDAC, etc.) or hypomethylating agent (HMA) or low dose cytarabine-based combination regimen including but not limited to venetoclax (e.g. venetoclax in combination with azacytidine, decitabine or cytarabine) ii. Four cycles of HMA monotherapy b. Relapsed AML is defined the appearance of ≥5% blasts in the bone marrow or peripheral blood at any time after achieving a CR, CRh, or CRi.
3. ECOG performance status 0 or 1.
4. Subjects must have a suitable stem cell donor identified who may donate cells in the event that the subject needs to undergo an allogeneic HSCT for rescue from prolonged marrow aplasia.

   Donor may be from related or unrelated matched source, haplo or cord, and must be found to be suitable according to the institution's standard criteria.
5. Adequate organ function defined as:

   1. Serum creatinine \<2.0 mg/100 mL.
   2. Total bilirubin \<2.0 mg/100 mL, unless benign congenital hyperbilirubinemia or due to leukemia organ involvement
   3. AST and/or ALT ≤5 × ULN, unless considered due to leukemic organ involvement.

Exclusion Criteria:

1. Diagnosis of acute promyelocytic leukemia.
2. Radiologically-detected or symptomatic CNS disease or CNS 3 disease (i.e., presence of ≥5/µL WBCs in CSF). Subjects with adequately treated CNS leukemia are eligible.
3. Oxygen saturation \<90% on room air.
4. Patients with prior allogeneic HSCT are allowed as long as HSCT occurred \> 3 months of signing ICF and without ongoing requirement for systemic graft-versus-host therapy.
5. Treatment with clofarabine or cladribine within 3 months prior to leukapheresis
6. The following medications are excluded:

   1. Steroids: Therapeutic doses of corticosteroids (greater than 10mg daily of prednisone or its equivalent) within 7 days of leukapheresis or 72 hours prior to CAR T cell infusion.
   2. Chemotherapy: Bridging chemotherapy including venetoclax must be discontinued at least 1 week prior to administration of conditioning chemotherapy, but FDA-approved oral targeted therapies such as IDH1/2, FLT3, and menin inhibitiors as well as hydroxyurea can be continued until at least 24 hours prior to the start of conditioning chemotherapy
7. Clinically significant cardiovascular disease, including stroke or myocardial infarction within 6 months prior to first study medication; or the presence of unstable angina or congestive heart failure of New York Heart Association Grade 2 or higher; or cardiac ejection fraction \<40%.
8. Uncontrolled clinically significant infections such as ongoing fever for 48 hours, persistent bacteremia or requiring new supplemental oxygen.
9. Positive serologic test results for HIV.
10. Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+.
11. Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR.
12. Active second malignancy that requires systemic treatments, with the exception of malignancy treated with curative intent and without evidence of disease for \>2 years before screening.
13. Live vaccine within 4 weeks prior to leukapheresis
14. Pregnant or lactating/breastfeeding women
15. Any prior or ongoing condition/issue that in the opinion of the investigator would make the patient ineligible for study

Where this trial is running

Basking Ridge, New Jersey and 6 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Acute Myeloid LeukemiaRelapsedRefractoryADCLEC.syn1 CAR T cellsCyclophosphamideFludarabine23-002
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.