UCART123v1.2 for Acute Myeloid Leukemia

(AMELI-01 Trial)

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen by Gail Roboz, Dr

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: Cellectis S.A.

No Placebo Group

Trial Summary

What is the purpose of this trial?

Phase I, open-label, dose-escalation and dose-expansion study evaluating the safety and efficacy of Universal Chimeric Antigen Receptor T-cell (UCART) targeting the Cluster of Differentiation 123 (CD123) in patients with relapsed/refractory acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety and clinical activity of Universal Chimeric Antigen Receptor T-cells targeting CD123 (UCART123v1.2) and determine the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).

Eligibility Criteria

This trial is for adults with relapsed or primary refractory Acute Myeloid Leukemia (AML) who have more than 5% bone marrow blasts and CD123+ blast cells. Participants must be in good physical condition with an ECOG-PS of ≤1 and proper organ function. For the dose-escalation part, a donor and transplant strategy must be identified before starting treatment.

Inclusion Criteria

Other criteria may apply

I have a donor and transplant plan ready before starting lymphodepletion.

I can carry out all my self-care but cannot do heavy physical work.

Exclusion Criteria

I have had gene or cell therapy before.

I have acute promyelocytic leukemia or leukemia that has spread to my brain.

I have not had rituximab or similar treatments in the last 3 months.

Participant Groups

The study tests UCART123v1.2, a Universal Chimeric Antigen Receptor T-cell therapy targeting CD123 in AML patients. It's an early-phase trial to find out how safe it is, its effectiveness, and the best dosage levels.

Group I: Dose Escalation Experimental Treatment 1 Intervention

UCART123v1.2 tested at several dose levels with different lymphodepletion regimens to establish Maximum Tolerated Dose (MTD) and identify Recommended Phase 2 Dose (RP2D) Dose Expansion: UCART123v1.2 administered at the RP2D determined from the dose escalation phase

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

H. Lee Moffitt Cancer Center & Research Institute Tampa, FL

Northwestern University Chicago, IL

University of Pennsylvania - Abramson Cancer Center Philadelphia, PA

MD Anderson Cancer Center Houston, TX

More Trial Locations

Who Is Running the Clinical Trial?

Cellectis S.A. Lead Sponsor

References