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Recruiting NCT06834282

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

Phase I Interventional AML Acute Myeloid Leukemia Refractory Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CER-1236, Cyclophosphamide, Fludarabine, Mesna.
Who it may be relevant to
Registry conditions: AML, Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

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.

Interventions

  • Drug CER-1236
    an autologous chimeric engulfment receptor T-cell
  • Drug Cyclophosphamide
    Lymphodepleting chemotherapy
  • Drug Fludarabine
    Lymphodepleting chemotherapy
  • Drug Mesna
    Chemoprotectant

Primary outcome measures

  • Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 1) [Time frame: 2 year]
  • Incidence of dose-limiting toxicities (DLTs) of CER-1236 Monotherapy - (Part 1) [Time frame: 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) [Time frame: 2 years]
Secondary outcome measures (4)
  • Estimation of the objective response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD) negativity rates - (Part 1) [Time frame: 2 years]
  • PK (Cmax) of CER-1236 - (Part 1) [Time frame: 2 years]
  • PK (AUC) of CER-1236 - (Part 1) [Time frame: 2 year]
  • Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 2) [Time frame: 2 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 4 centers
  • University of California, Davis Comprehensive Cancer Center — Sacramento
  • Colorado Blood Cancer Institute — Denver
  • Sarah Cannon Research Insitute — Nashville
  • The University of Texas MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT06834282 · CER-1-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗