CertainT-1CER-1236 for Acute Myeloid Leukemia Patients
CER-1236
+ Cyclophosphamide
+ Fludarabine
Hematologic Diseases+4
+ Hemic and Lymphatic Diseases
+ Leukemia
Treatment Study
Summary
Study start date: April 7, 2025
Actual date on which the first participant was enrolled.This clinical trial is focused on testing a new treatment called CER-1236 for patients with a type of blood cancer known as acute myeloid leukemia (AML), specifically those whose cancer has returned or is hard to treat. The study is particularly interested in patients who have measurable residual disease or a genetic mutation called TP53mut. The goal is to see if CER-1236, which is a special type of cell therapy that targets a specific protein involved in the cancer, is safe and effective. This research is crucial because current treatment options for these patients are limited, and finding new, effective therapies can significantly improve outcomes. The study is conducted in two parts. In the first part, different doses of CER-1236 are given to patients to determine which dose is safe and should be used in the second part. The treatment involves using the patient's own modified immune cells, which are then reintroduced to their body to attack the cancer cells. The study checks how safe the treatment is and whether it works to control the cancer. This involves closely monitoring participants for any side effects and assessing the impact of the therapy on their disease. This approach helps ensure that the treatment is not only effective but also safe for the patients involved.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.18 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 85 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 4 locations
Colorado Blood Cancer Institute
Denver, United StatesOpen Colorado Blood Cancer Institute in Google MapsSarah Cannon Research Insitute
Nashville, United StatesThe University of Texas MD Anderson Cancer Center
Houston, United StatesUniversity of California, Davis Comprehensive Cancer Center
Sacramento, United States