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

Part of paid clinical trials in Sacramento, California.

Sponsor
CERo Therapeutics Holdings, Inc.
Study ID
NCT06834282
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Apr 7, 2025
Status verified
Mar 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2029

Study Design

Enrollment
18 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Single Agent CER-1236
    AML patient treated with a single dose of CER-1236 monotherapy
  • Experimental: Part 2: Single Agent CER-1236
    AML patient treated with a single dose of CER-1236 monotherapy

Primary Outcome Measure

Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 1) [ Time Frame: 2 year ]

Locations (4)

FacilityCityStateZIPSite coordinators
University of California, Davis Comprehensive Cancer CenterSacramentoCalifornia95817
Brian Jonas, MD
[email protected]
916-382-6970
Alpha Stem Cell Clinic
[email protected]
916-734-
Brian Jonas, MD (PRINCIPAL_INVESTIGATOR)
Colorado Blood Cancer InstituteDenverColorado80218
Maris Michael, MD
[email protected]
Michael Maris, MD (PRINCIPAL_INVESTIGATOR)
Sarah Cannon Research InsituteNashvilleTennessee37203
AskSarah Help Line Have Cancer Questions? askSARAH | Sarah Cannon
844-482-4812
The University of Texas MD Anderson Cancer CenterHoustonTexas77030
Abhishek Maiti, MD
[email protected]
713-745-3228
Abhishek Maiti, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Sacramento, CA

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
University of California, Davis Comprehensive Cancer Center· Sacramento, CAColorado Blood Cancer Institute· Denver, COSarah Cannon Research Insitute· Nashville, TNThe University of Texas MD Anderson Cancer Center· Houston, TX

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