CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF) (CertainT-1)

Phase 1/1b First-in-human Study of Autologous Chimeric Engulfment Receptor T-Cell CER-1236 in Patients With Acute Myeloid Leukemia, Myelodysplastic Syndrome, and Myelofibrosis (CertainT-1)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Myeloid Leukemia; AML; Refractory Acute Myeloid Leukemia
• Intervention / Treatment: Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Mesna; Drug: CER-1236

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Not yet recruiting
      • University of California, Davis Comprehensive Cancer Center
      • Principal Investigator: Brian Jonas, MD
      • Contact: Brian Jonas, MD; Phone Number: 916-382-6970; Email: bajonas@health.ucdavis.edu
      • Contact: Alpha Stem Cell Clinic; Phone Number: 916-734-; Email: OCRReferral@health.ucdavis.edu
  • Colorado
    • Denver, Colorado, United States, 80218
      • Recruiting
      • Colorado Blood Cancer Institute
      • Principal Investigator: Michael Maris, MD
      • Contact: Maris Michael, MD; Email: PSLMDLCBCINewClinicPatient@HCAHealthcare.com
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Recruiting
      • Sarah Cannon Research Insitute
      • Contact: AskSarah Help Line Have Cancer Questions? askSARAH | Sarah Cannon; Phone Number: 844-482-4812
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • The University of Texas MD Anderson Cancer Center
      • Principal Investigator: Abhishek Maiti, MD
      • Contact: Abhishek Maiti, MD; Phone Number: 713-745-3228; Email: amaiti@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Single Agent CER-1236; AML patient treated with a single dose of CER-1236 monotherapy	Drug: Cyclophosphamide; Lymphodepleting chemotherapy; Drug: Fludarabine; Lymphodepleting chemotherapy; Drug: Mesna; Chemoprotectant; Drug: CER-1236; an autologous chimeric engulfment receptor T-cell
Experimental: Part 2: Single Agent CER-1236; AML patient treated with a single dose of CER-1236 monotherapy	Drug: Cyclophosphamide; Lymphodepleting chemotherapy; Drug: Fludarabine; Lymphodepleting chemotherapy; Drug: Mesna; Chemoprotectant; Drug: CER-1236; an autologous chimeric engulfment receptor T-cell

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimation of the objective response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD) negativity rates - (Part 1)	Escalation Period	2 years
PK (Cmax) of CER-1236 - (Part 1)	Escalation Period	2 years
PK (AUC) of CER-1236 - (Part 1)	Escalation Period	2 year
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 2)	Expansion Period	2 years

Collaborators and Investigators

• Sponsor: CERo Therapeutics Holdings, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: February 14, 2025
• First Submitted That Met QC Criteria: February 14, 2025
• First Posted (Actual): February 19, 2025

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Relapsed Acute Myeloid Leukemia
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute; Sulfur Compounds; Organic Chemicals; Hydrocarbons, Acyclic; Hydrocarbons; Alkanes; Alkanesulfonates; Alkanesulfonic Acids; Sulfonic Acids; Sulfur Acids; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Sulfhydryl Compounds; Cyclophosphamide; Mesna; fludarabine
• Other Study ID Numbers: CER-1-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No