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.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
an autologous chimeric engulfment receptor T-cell
Lymphodepleting chemotherapy
Lymphodepleting chemotherapy
University of California, Davis Comprehensive Cancer Center
Sacramento, California, United States
RECRUITINGColorado Blood Cancer Institute
Denver, Colorado, United States
RECRUITINGSarah Cannon Research Insitute
Nashville, Tennessee, United States
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 1)
Escalation Period
Time frame: 2 year
Incidence of dose-limiting toxicities (DLTs) of CER-1236 Monotherapy - (Part 1)
Escalation Period
Time frame: 28 days
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
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
PK (Cmax) of CER-1236 - (Part 1)
Escalation Period
Time frame: 2 years
PK (AUC) of CER-1236 - (Part 1)
Escalation Period
Time frame: 2 year
Incidence of adverse events (AEs) and serious adverse events (SAEs) - (Part 2)
Expansion Period
Time frame: 2 years
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Chemoprotectant
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGFred Hutchinson Cancer Center
Seattle, Washington, United States
NOT_YET_RECRUITING