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

ConditionsAMLAcute Myeloid LeukemiaRefractory Acute Myeloid Leukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-85
SponsorCERo Therapeutics Holdings, Inc.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • CER-1236

    Drug

    an autologous chimeric engulfment receptor T-cell

  • Cyclophosphamide

    Drug

    Lymphodepleting chemotherapy

  • Fludarabine

    Drug

    Lymphodepleting chemotherapy

  • Mesna

    Drug

    Chemoprotectant

Treatment groups

18 Participants
are divided into 2 treatment groups
Group A: Part 1: Single Agent CER-1236Experimental treatment 4 interventions
Group B: Part 2: Single Agent CER-1236Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 1)

Escalation Period

Time frame
2 year
2

Incidence of dose-limiting toxicities (DLTs) of CER-1236 Monotherapy - (Part 1)

Escalation Period

Time frame
28 days
3

Estimation of the objective response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD) negativity rates - (Part 2)

Expansion Period

Time frame
2 years

Secondary outcomes

1

Estimation of the objective response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD) negativity rates - (Part 1)

Escalation Period

Time frame
2 years
2

PK (Cmax) of CER-1236 - (Part 1)

Escalation Period

Time frame
2 years
3

PK (AUC) of CER-1236 - (Part 1)

Escalation Period

Time frame
2 year
4

Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 2)

Expansion Period

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

CERo Therapeutics Holdings, Inc.

Lead sponsor

Source ClinicalTrials.gov
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