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NCT05748197 · ClinicalTrials.gov registry record · Phase 1
A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia
A Phase 1 study of Acute Myeloid Leukemia, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 7
- Study locations
NCT05748197: Recruiting Phase 1 study of Acute Myeloid Leukemia, sponsored by Memorial Sloan Kettering Cancer Center.
NCT05748197 is a Phase 1 study of Acute Myeloid Leukemia that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 40 participants, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (66% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05748197, a Phase 1 study of Acute Myeloid Leukemia, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
Dose escalation of ADCLEC.syn1 CAR T cells will follow Bayesian optimal interval (BOIN) design to inform dose-escalation decisions and potential maximum tolerated dose (MTD) estimation. Patients will be enrolled in cohorts of 3.
Conditions Studied
Interventions
- BIOLOGICAL ADCLEC.syn1 CAR T cells
- DRUG Conditioning chemotherapy
Study Locations (7)
New York
- Memorial Sloan Kettering Cancer Commack - Suffolk (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2024-04-18 |
| Est. Completion | 2028-04-18 |
| Phase | Phase 1 |
What NCT05748197 shows while recruiting
NCT05748197 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 116-participant average among 306 other Acute Myeloid Leukemia trials with a reported enrollment target (66% lower).
The record links to 1 condition, with Acute Myeloid Leukemia appearing as the primary indexed condition, and to 2 interventions - of which ADCLEC.syn1 CAR T cells is the first listed.
NCT05748197 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT05748197 about?
NCT05748197 is a clinical study titled "A Study of ADCLEC.syn1 in People With Acute Myeloid Leukemia". 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 i...
What is the current status of trial NCT05748197?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2024-04-18. Estimated completion is 2028-04-18.
What conditions does trial NCT05748197 study?
This clinical trial studies the following conditions: Acute Myeloid Leukemia.
What interventions are being tested in trial NCT05748197?
The interventions under investigation include: ADCLEC.syn1 CAR T cells (BIOLOGICAL), Conditioning chemotherapy (DRUG).
Who is sponsoring clinical trial NCT05748197?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05748197 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05748197's enrollment target sits among peer trials
40 170th of 306 higher than 128 of 306 other Acute Myeloid Leukemia trials
participants (enrollment target), bucketed by value
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