Trial Title:
A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia
NCT ID:
NCT05748197
Condition:
Acute Myeloid Leukemia
Conditions: Official terms:
Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Conditions: Keywords:
Relapsed
Refractory
ADCLEC.syn1 CAR T cells
Cyclophosphamide
Fludarabine
23-002
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Sequential Assignment
Intervention model description:
This is a phase I, open-label, dose-escalation/dose expansion trial.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
ADCLEC.syn1 CAR T cells
Description:
There are 4 planned flat-dose levels: 25 × 10^6, 75 × 10^6 , 225 × 10^6 , and 450 × 10^6
CAR T cells and 1 de-escalation dose: 10 × 10^6 CAR T cells.
Arm group label:
ADCLEC.syn1 CAR T cells
Intervention type:
Drug
Intervention name:
Conditioning chemotherapy
Description:
Fludarabine 30 mg/m2 daily for 3 days and cyclophosphamide 500 mg/m2 daily for 3 days.
Arm group label:
ADCLEC.syn1 CAR T cells
Summary:
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.
Criteria for 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: 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jae Park, MD
Phone:
646-608-2091
Facility:
Name:
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jae Park, MD
Phone:
646-608-2091
Facility:
Name:
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jae Park, MD
Phone:
646-608-2091
Facility:
Name:
Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jae Park, MD
Phone:
646-608-2091
Facility:
Name:
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jae Park, MD
Phone:
646-608-2091
Facility:
Name:
Memorial Sloan Kettering Cancer Center
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jae Park, MD
Phone:
646-608-2091
Facility:
Name:
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jae Park, MD
Phone:
646-608-2091
Start date:
April 18, 2024
Completion date:
April 18, 2028
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
Takeda
Agency class:
Industry
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05748197
http://www.mskcc.org/mskcc/html/44.cfm
