RecruitingPhase 1

A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests ADCLEC.syn1 CAR T cells in adults with acute myeloid leukemia (AML), a blood cancer that came back or did not respond to treatment. Researchers will find the highest dose that causes few or mild side effects. They will then test that dose in a new group to see how well it treats AML.

The purpose of this study is to test the safety of ADCLEC.syn1 CAR T cells in people with relapsed or refractory AML. The researchers will try to find the highest dose of ADCLEC.syn1 CAR T cells that causes few or mild side effects in participants. Once the researchers find this dose, it will test it in a new group of participants to see if it is effective in treating their relapsed/refractory AML.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You must be at least 18 years old when you sign the consent form.
  • Your AML must have come back after treatment, with at least 5% immature cancer cells in your blood or bone marrow, or not have responded to the treatments listed in the study.
  • You must be fully active or able to walk and do light work, even if you cannot do hard physical activity.
  • You must have a suitable stem cell donor ready in case you need a transplant because your bone marrow stops making blood cells for a long time.
  • Your kidney and liver blood tests must meet the study’s limits. Some liver test exceptions apply if changes are due to leukemia or a harmless inherited condition.

Who can't join

  • You cannot have acute promyelocytic leukemia, a type of AML, or leukemia affecting the brain or spinal cord unless it has been adequately treated.
  • You cannot have a blood oxygen level below 90% while breathing room air or certain serious heart or blood vessel problems. These include a stroke or heart attack within the past 6 months.
  • A prior donor stem cell transplant must have been more than 3 months before consent. You must not still need whole-body treatment for graft-versus-host disease, when donor cells attack your body.
  • Certain medicines must be stopped before blood cell collection or study treatment. These include clofarabine or cladribine within 3 months before collection, certain steroid doses, and chemotherapy. A live vaccine within 4 weeks before collection is not allowed.
  • You cannot have a serious infection that is not controlled, a positive HIV test, or current hepatitis B or C infection based on the study’s blood tests.
  • You cannot have another active cancer needing whole-body treatment. An exception applies to cancer treated to cure it, with no signs of disease for more than 2 years before screening.
  • You cannot be pregnant or breastfeeding.
  • You cannot have another health condition or issue that the study doctor believes makes you unable to join.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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

Study sites (7)

NJ

NY