Clinical trial NCT06834282: CER-1236 in Patients With Acute Myeloid Leukemia (AML)
Official title: Phase 1/1b First-in-human Study of Autologous Chimeric Engulfment Receptor T-Cell CER-1236 in Patients With Acute Myeloid Leukemia (CertainT-1)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: AML
Acute Myeloid Leukemia
Refractory Acute Myeloid Leukemia
Keywords: Relapsed Acute Myeloid Leukemia
Lead sponsor: CERo Therapeutics Holdings, Inc.
Sponsor class: INDUSTRY
First posted: 2025-02-19
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multiple ascending dose and dose expansion study of CER-1236 administered as a single agent.
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 1)
timeFrame: 2 year
measure: Incidence of dose-limiting toxicities (DLTs) of CER-1236 Monotherapy - (Part 1)
timeFrame: 28 days
measure: Estimation of the objective response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD) negativity rates - (Part 2)
timeFrame: 2 years
Secondary outcomes:
measure: Estimation of the objective response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD) negativity rates - (Part 1)
timeFrame: 2 years
measure: PK (Cmax) of CER-1236 - (Part 1)
timeFrame: 2 years
measure: PK (AUC) of CER-1236 - (Part 1)
timeFrame: 2 year
measure: Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 2)
timeFrame: 2 years
Other outcomes:
Locations:
city: Denver
country: United States
facility: Colorado Blood Cancer Institute
state: Colorado
city: Houston
country: United States
facility: The University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
References: