RECRUITING

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

Conditions

Acute Myeloid Leukemia Relapsed Refractory ADCLEC.syn1 CAR T cells Cyclophosphamide Fludarabine 23-002

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-18

Study Completion:2028-04-18

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05748197

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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: 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. 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.	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: Should be stopped one week prior to leukapheresis or starting conditioning chemotherapy. Hydroxyurea for cytoreduction can be administered up to 72 hours before leukapheresis or CAR T cell infusion. 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. Previous treatment with CAR therapy 10. Positive serologic test results for HIV. 11. Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+. 12. Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR. 13. 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. 14. Live vaccine within 4 weeks prior to leukapheresis 15. Pregnant or lactating/breastfeeding women 16. Any prior or ongoing condition/issue that in the opinion of the investigator would make the patient ineligible for study

Inclusion Criteria

Exclusion 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:
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.
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.

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: Should be stopped one week prior to leukapheresis or starting conditioning chemotherapy. Hydroxyurea for cytoreduction can be administered up to 72 hours before leukapheresis or CAR T cell infusion.
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. Previous treatment with CAR therapy
10. Positive serologic test results for HIV.
11. Acute or chronic HBV infection as assessed by serologic (HBVsAg) or PCR results, defined as HBVsAg+, HBVcAb+, HBV PCR+. 12. Acute or chronic HCV infection as assessed by serologic (HCV ab) or PCR results, defined as HCV Ab+ with reflex to positive HCV PCR.
13. 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.
14. Live vaccine within 4 weeks prior to leukapheresis 15. Pregnant or lactating/breastfeeding women 16. Any prior or ongoing condition/issue that in the opinion of the investigator would make the patient ineligible for study

Contacts and Locations

Study Contact

Jae Park, MD

CONTACT

646-608-2091

parkj6@mskcc.org

Mark Geyer, MD

CONTACT

646-608-3745

Principal Investigator

Jae Park, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (Limited Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (Limited Protocol Activities)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Jae Park, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-18

Study Completion Date2028-04-18

Study Record Updates

Study Start Date2024-04-18

Study Completion Date2028-04-18

Terms related to this study

Keywords Provided by Researchers

Relapsed
Refractory
ADCLEC.syn1 CAR T cells
Cyclophosphamide
Fludarabine
23-002

Additional Relevant MeSH Terms

Acute Myeloid Leukemia