CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)

NCT06834282 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: CER-1-1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Acute Myeloid Leukemia; Refractory Acute Myeloid Leukemia; AML

Keywords

Relapsed Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (3)

• Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 1)

  Escalation Period

  2 year

• Incidence of dose-limiting toxicities (DLTs) of CER-1236 Monotherapy - (Part 1)

  Escalation Period

  28 days

• Estimation of the objective response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD) negativity rates - (Part 2)

  Expansion Period

  2 years

Secondary Outcomes (4)

• Estimation of the objective response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD) negativity rates - (Part 1)

  2 years

• PK (Cmax) of CER-1236 - (Part 1)

  2 years

• PK (AUC) of CER-1236 - (Part 1)

  2 year

• Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 2)

  2 years

Study Arms (2)

Part 1: Single Agent CER-1236

EXPERIMENTAL

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

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

Part 2: Single Agent CER-1236

EXPERIMENTAL

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

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

Interventions

CER-1236 DRUG

an autologous chimeric engulfment receptor T-cell

Part 1: Single Agent CER-1236; Part 2: Single Agent CER-1236

Cyclophosphamide DRUG

Lymphodepleting chemotherapy

Part 1: Single Agent CER-1236; Part 2: Single Agent CER-1236

Fludarabine DRUG

Lymphodepleting chemotherapy

Part 1: Single Agent CER-1236; Part 2: Single Agent CER-1236

Mesna DRUG

Chemoprotectant

Part 1: Single Agent CER-1236; Part 2: Single Agent CER-1236

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CERo Therapeutics Holdings, Inc.: lead

Study Sites (4)

University of California, Davis Comprehensive Cancer Center

Sacramento, California, 95817, United States

NOT YET RECRUITING

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

RECRUITING

Sarah Cannon Research Insitute

Nashville, Tennessee, 37203, United States

RECRUITING

The University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cyclophosphamide; fludarabine; Mesna

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: April 7, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)