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CER-1236

Phase 1

AML | Small molecule | Oncology |cbdMD, Inc.|Last Updated: Aug 26, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMC
Total Trials1
Total Enrollment18

FDA Designations

No designations recorded

Clinical trial landscape

CER-1236 · 1 trial · 3 indications

Phase 1 1
NCT06834282CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)AML
RECRUITING18 Analytics
PHASE1RECRUITING
CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)
AML
NCT0683428218
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Study Endpoints

Primary Endpoints

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

Escalation Period

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

Escalation Period

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

Expansion Period

Secondary Endpoints

Estimation of the objective response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD) negativity rates - (Part 1)
2 years
PK (Cmax) of CER-1236 - (Part 1)
2 years
PK (AUC) of CER-1236 - (Part 1)
2 year
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Part 1: Single Agent CER-1236EXPERIMENTALAML patient treated with a single dose of CER-1236 monotherapy
Part 2: Single Agent CER-1236EXPERIMENTALAML patient treated with a single dose of CER-1236 monotherapy

Interventions

NameTypeDescription
CER-1236DRUGan autologous chimeric engulfment receptor T-cell
CyclophosphamideDRUGLymphodepleting chemotherapy
FludarabineDRUGLymphodepleting chemotherapy
MesnaDRUGChemoprotectant
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Eligibility Criteria

Age Range18 Years to 85 Years
SexALL
Healthy VolunteersNo
Study Sites5

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 apheres...

Countries:United States
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