CER-1236 in Patients With Acute Myeloid Leukemia (AML)

Description

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

AML, Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia

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Study Overview

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Study Details

Study 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.

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

CER-1236 in Patients With Acute Myeloid Leukemia (AML)

Condition
AML
Intervention / Treatment

-

Contacts and Locations

Denver

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

Houston

The University of Texas MD Anderson Cancer Center, Houston, Texas, United States, 77030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 85 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

CERo Therapeutics Holdings, Inc.,

Study Record Dates

2029-12-31