Study Evaluating Safety and Efficacy of UCART123v1.2 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-19

Study Completion Date

2025-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Relapsed/Refractory Acute Myeloid Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dose Escalation

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

Group Type EXPERIMENTAL

UCART123v1.2

Intervention Type BIOLOGICAL

Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor Biological/vaccine: CLLS52 A monoclonal antibody that recognizes the CD52 antigen Other Names: Alemtuzumab

Interventions

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UCART123v1.2

Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor Biological/vaccine: CLLS52 A monoclonal antibody that recognizes the CD52 antigen Other Names: Alemtuzumab

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients with relapsed or primary refractory AML (as defined in World Health Organization \[WHO\] criteria) with ≥5% bone marrow blasts
* Patients with CD123+ blast cells (verified by flow cytometry)
* Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of ≤1
* Adequate organ function, including bone marrow, renal, hepatic, pulmonary, and cardiac function based on the last assessment performed within screening period
* (Dose-escalation) Identified donor and transplant strategy prior to lymphodepletion (LD)
* Other criteria may apply

Exclusion Criteria

* Patients with acute promyelocytic leukemia (APL) or central nervous system (CNS) Leukemia
* Previous investigation gene or cell therapy (including CAR)
* \> 1 prior allogeneic stem cell transplantations (SCTs)
* Prior treatment with rituximab or other anti-cluster of differentiation 20 (anti-CD20) therapy within 3 months
* Any known active or uncontrolled infection
* Other criteria may apply

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No