CER-1236 in Patients With Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), and Myelofibrosis (MF)
Condition(s) studied
Investigational drug(s) / intervention(s)
CER-1236: an autologous chimeric engulfment receptor T-cell
Cyclophosphamide: Lymphodepleting chemotherapy
Fludarabine: Lymphodepleting chemotherapy
Mesna: Chemoprotectant
Study 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.
Eligibility
Primary outcome measure(s)
- 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
Trial sites (5)
| Facility | City | Region | Status |
|---|---|---|---|
| University of California, Davis Comprehensive Cancer Center | Sacramento | California | Recruiting |
| Colorado Blood Cancer Institute | Denver | Colorado | Recruiting |
| Sarah Cannon Research Insitute | Nashville | Tennessee | Recruiting |
| The University of Texas MD Anderson Cancer Center | Houston | Texas | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06834282 on ClinicalTrials.gov ↗ ← All trials in the USA