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CAR T-cell Therapy

UCART123v1.2 for Acute Myeloid Leukemia (AMELI-01 Trial)

Phase 1

Recruiting

Led By Gail Roboz, Dr

Research Sponsored by Cellectis S.A.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with CD123+ blast cells (verified by flow cytometry)

Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of ≤1

Must not have

Previous investigation gene or cell therapy (including CAR)

Patients with acute promyelocytic leukemia (APL) or central nervous system (CNS) Leukemia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new treatment for leukemia that targets the CD123 protein. The purpose is to find the maximum tolerated dose and to see if it is effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include immune system reactions, infusion-related responses, impact on blood counts leading to increased infection risk or bleeding problems, fatigue, fever, and potential harm to organs like liver or kidneys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My leukemia cells test positive for CD123.

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

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My AML has returned or didn't respond to treatment, with more than 5% of my bone marrow cells being cancerous.

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My organs, including my bone marrow, kidneys, liver, lungs, and heart, are functioning well.

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My AML has returned or didn't respond to treatment, with more than 5% of my bone marrow cells being blasts.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had gene or cell therapy before.

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

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I do not have any active or uncontrolled infections.

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I have had more than one stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events (AE)/serious adverse events (SAE)/Dose Limiting Toxicities (DLT) [Safety and Tolerability]

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment1 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

0 / 9Eligibility criteria met