CER-1236 in Patients With Acute Myeloid Leukemia (AML)

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

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-07

Study Completion Date

2029-12-31

Brief Summary

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This is a ﬁrst in human, multi center, open label, phase 1/1b study to evaluate the safety and preliminary efﬁcacy of CER-1236 in patients with relapsed/refractory (R/R), measurable residual disease (MRD) positive acute myeloid leukemia (AML), or TP53mut disease.

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Detailed Description

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CER-1236 is a first in class chimeric engulfment receptor T-cell therapy candidate that targets the Tim4 ligand.

This is a ﬁrst in human, multi center, open label, phase 1/1b study to evaluate the safety and preliminary efﬁcacy of CER-1236 in patients with relapsed/refractory (R/R), measurable residual disease (MRD) positive acute myeloid leukemia (AML), or TP53mut disease.

The study is divided into Part 1 (escalation phase) and Part 2 (expansion phase).

Part 1 (Escalation Phase): The primary objectives of Part 1 are to deﬁne the safety of different doses of CER-1236 and to deﬁne the recommended dose for Part 2 (RP2D) of CER-1236.

Part 2 (Expansion Phase): The objective of the Part 2 expansion cohort is to evaluate the safety and efﬁcacy of CER-1236 in patients with acute myeloid leukemia.

Conditions

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AML Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Multiple ascending dose and dose expansion study of CER-1236 administered as a single agent.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Intervention Type DRUG

Chemoprotectant

Interventions

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CER-1236

an autologous chimeric engulfment receptor T-cell

Intervention Type DRUG

Cyclophosphamide

Lymphodepleting chemotherapy

Intervention Type DRUG

Fludarabine

Lymphodepleting chemotherapy

Intervention Type DRUG

Mesna

Chemoprotectant

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients need to have a confirmed diagnosis of de novo or secondary AML, or myelodysplastic syndrome (MDS)/AML with 10% to 19% blasts, per the International Consensus Classification 2022 or the WHO 2022 classification.
* Absolute lymphocyte count \>0.3 x 109/L prior to apheresis.
* Eastern cooperative oncology group (ECOG) performance status 0 to 1.

Exclusion Criteria

* Prior therapy with a permanently integrated, genetically modified cell product.
* No measurable leukemia on the screening bone marrow evaluation prior to any bridging therapy.
* Active autoimmune disease or history of autoimmune disease requiring treatment within the prior 2 years. Patients with history of autoimmune thyroiditis or type 1 diabetes well controlled on replacement regimen are eligible.
* A known hypersensitivity or severe allergy to fludarabine, cyclophosphamide, or study drug components or diluents.
* Any other medical, psychological, or social condition that may interfere with study participation or compliance, or compromise patient safety in the opinion of the physician.
* Primary immunodeficiency disorder.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No