CER-1236 in Patients With Acute Myeloid Leukemia (AML) (CertainT-1)

CERo Therapeutics Holdings, Inc.

Status and phase: Enrolling; Phase 1

Conditions: AML; Refractory Acute Myeloid Leukemia; Acute Myeloid Leukemia

Treatments: Drug: Cyclophosphamide; Drug: CER-1236; Drug: Mesna; Drug: Fludarabine

Study type: Interventional

Funder types: Industry

Identifiers

NCT06834282

CER-1-1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Part 1: Single Agent CER-1236

Experimental group

Description:

AML patient treated with a single dose of CER-1236 monotherapy

Treatment:

Drug: Fludarabine

Drug: Mesna

Drug: CER-1236

Drug: Cyclophosphamide

Part 2: Single Agent CER-1236

Experimental group

Description:

AML patient treated with a single dose of CER-1236 monotherapy

Treatment:

Drug: Fludarabine

Drug: Mesna

Drug: CER-1236

Drug: Cyclophosphamide