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

a study on Acute Myeloid Leukemia Leukemia Myelodysplastic Syndrome

Summary

Eligibility
for people ages 18-85 (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
study ends around
Principal Investigator
by Brian Jonas, MD

Description

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.

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)

Details

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.

Keywords

AML, Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia, Relapsed Acute Myeloid Leukemia, Leukemia, Myeloid, Acute, Cyclophosphamide, fludarabine, Mesna, CER-1236, Single Agent CER-1236

Eligibility

You can join if…

Open to people ages 18-85

  • 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 CAN'T join 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.

Locations

  • University of California, Davis Comprehensive Cancer Center accepting new patients
    Sacramento California 95817 United States
  • Colorado Blood Cancer Institute accepting new patients
    Denver Colorado 80218 United States
  • The University of Texas MD Anderson Cancer Center accepting new patients
    Houston Texas 77030 United States
  • Sarah Cannon Research Insitute accepting new patients
    Nashville Tennessee 37203 United States

Lead Scientist at UC Davis

  • Brian Jonas, MD
    Professor, MED: Int Med HMCTBMT, School of Medicine. Authored (or co-authored) 108 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
CERo Therapeutics Holdings, Inc.
ID
NCT06834282
Phase
Phase 1 research study
Study Type
Interventional
Participants
Expecting 18 study participants
Last Updated
Contact us about this trial