Not currently recruiting at University of California Health

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 UC Davis
Dates
study started
study ends around
Principal Investigator
by Brian Jonas, MD (ucdavis)

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 not yet accepting 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 University of California Health

  • Brian Jonas, MD (ucdavis)
    Professor, MED: Int Med HMCTBMT, School of Medicine. Authored (or co-authored) 101 research publications

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
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