Phase 1/1b First-in-human Study of Autologous Chimeric Engulfment Receptor T-Cell CER-1236 in Patients With Acute Myeloid Leukemia (CertainT-1)
Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:
• 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.
Locations
United States
Colorado
Colorado Blood Cancer Institute
RECRUITING
Denver
Tennessee
Sarah Cannon Research Insitute
RECRUITING
Nashville
Texas
The University of Texas MD Anderson Cancer Center
RECRUITING
Houston
Time Frame
Start Date: 2025-04-07
Estimated Completion Date: 2029-12-31
Participants
Target number of participants: 18
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: CERo Therapeutics Holdings, Inc.