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

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT05748197
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ADCLEC.syn1 CAR T cells — BIOLOGICAL
    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.
  • Conditioning chemotherapy — DRUG
    Fludarabine 30 mg/m2 daily for 3 days and cyclophosphamide 500 mg/m2 daily for 3 days.

Study Details

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.

Key Dates

Start date
Apr 18, 2024
Status verified
Mar 2026
Primary completion
Apr 18, 2028
Completion
Apr 18, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ADCLEC.syn1 CAR T cells
    The dose escalation cohort size of 3 patients in each cohort will be infused with escalating doses of ADCLEC.syn1 CAR T cells to inform the RP2D. 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. After dose escalation, one or two dose levels will be selected for dose expansion cohort(s).Two to 7 days following completion of the conditioning chemotherapy, the frozen CAR T cells will be thawed and administered. Conditioning chemotherapy may occur either outpatient or inpatient, and T cell infusions will occur as inpatient. Up to approximately 12 additional patients each if two doses are selected or approximately 16 additional patients, if one dose is selected, will be treated in the dose expansion phase to determine RP2D.

Primary Outcome Measure

maximum tolerated dose (MTD) [ Time Frame: 2 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Jae Park, MD
646-608-2091
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Jae Park, MD
646-608-2091
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Jae Park, MD
646-608-2091
Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)CommackNew York11725
Jae Park, MD
646-608-2091
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Jae Park, MD
646-608-2091
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Jae Park, MD
646-608-2091
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Jae Park, MD
646-608-2091

Find similar trials in Basking Ridge, NJ

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center· New York, NY

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