Trials / Recruiting
RecruitingNCT06017258
A Study of CD371-YSNVZIL-18 CAR T Cells in People With Acute Myeloid Leukemia
Phase I Trial of CLEc12a (CD371) Targeted ArmoRed Immune Effector Cells in Patients With Relapsed/Refractory Acute Myeloid Leukemia (CLEAR-AML)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- Sponsor
- Memorial Sloan Kettering Cancer Center · Academic / Other
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to find out whether CD371-YSNVZ-IL18 CAR T cells are safe, and to look for the highest dose of CD371-YSNVZ-IL18 CAR T cells that cause few or mild side effects in participants.
Conditions
- Refractory Acute Myeloid Leukemia
- Relapsed Acute Myeloid Leukemia
- Acute Myeloid Leukemia
- Acute Myeloid Leukemia, in Relapse
- Acute Myeloid Leukemia Refractory
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | CD371-specific/YSNVz/I-18 CAR T cells | Cohorts will be infused with escalating doses of CD371-specific/YSNVz/IL-18 CAR T cells with lymphodepleting chemotherapy (LDC) to establish the maximum tolerated dose (MTD). There is a third, lower dose level (step-down dose) available for dose de-escalation in the event of severe toxicity at the first planned dose level. |
Timeline
- Start date
- 2023-08-22
- Primary completion
- 2026-08-22
- Completion
- 2026-08-22
- First posted
- 2023-08-30
- Last updated
- 2026-02-19
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06017258. Inclusion in this directory is not an endorsement.