CERo Therapeutics Initiates Phase 1 Trial for Novel AML Treatment
CERo Therapeutics Launches Phase 1 Clinical Trial on CER-1236
In a significant advancement for cancer treatment, CERo Therapeutics Holdings, Inc. (NASDAQ: CERO) has begun its Phase 1 clinical trial for CER-1236, specifically targeting acute myeloid leukemia (AML). With the dosing of the first patient, the company is now embarking on an important journey of evaluating this innovative therapeutic option.
Details of the Clinical Trial
This clinical study is designed as a first-in-human, multi-center approach that assesses both safety and preliminary efficacy of CER-1236. The investigation primarily focuses on AML patients who are relapsed or refractory, those who are in remission with measurable residual disease, as well as newly diagnosed patients with TP53 mutated myelodysplastic syndromes (MDS) or AML.
Trial Structure
The trial features a two-part design. The first part is a dose escalation phase to identify the highest tolerated dose and determine the recommended dose for the subsequent Phase 2. Following this, an expansion phase will aim to further evaluate the safety and efficacy of CER-1236.
Outcomes and Metrics
Primary outcome measures for this trial include monitoring the occurrence of adverse events (AEs) and serious adverse events (SAEs), along with assessing the incidence of dose-limiting toxicities. Furthermore, the trial looks to estimate overall response rates (ORR), complete responses (CR), composite complete responses (cCR), and measurable residual disease (MRD).
Insights from Leadership
Robert Sikorski, M.D., Ph.D., CERo Therapeutics’ Chief Medical Officer, celebrated this milestone, highlighting the significance of the first patient being dosed. He stated, "The completion of first-in-human dosing represents a clinical development milestone for CER-1236, a novel autologous CAR-T therapeutic candidate targeting TIM 4L. Protocol-specified evaluations of safety, pharmacodynamic, and pharmacokinetic endpoints are in progress. We look forward to communicating results as data matures.”
Ongoing Research Collaborations
The lead investigator of this trial, Dr. Abhishek Maiti from The University of Texas MD Anderson Cancer Center, collaborated closely with the CERo team on publishing noteworthy preclinical data that has garnered attention in the field. Their efforts have laid a solid foundation for the clinical trial.
Future Discussions on the Trial
As part of the ongoing development process, CERo is set to present its findings at the next American Society of Clinical Oncology Annual Meeting. Scheduled from May 30 to June 3, the conference is expected to highlight breakthroughs in the treatment of hematologic malignancies.
Company Vision
CERo Therapeutics is dedicated to pioneering the next generation of engineered T cell therapies. Their unique approach allows integration of both innate and adaptive immune system characteristics into one therapeutic construct. This is expected to facilitate a more effective immune response, targeting both hematological malignancies and solid tumors.
About CERo Therapeutics Holdings, Inc.
CERo is committed to advancing the forefront of immunotherapy by developing remarkable engineered T cell therapeutics. Their innovative cellular immunotherapy platform, which aims to eliminate cancer cells using patient-derived T cells, fosters hope for improved cancer therapy outcomes over existing treatments like CAR-T cell therapy.
Frequently Asked Questions
What is CER-1236?
CER-1236 is a novel autologous CAR-T therapeutic candidate developed by CERo Therapeutics, targeted at treating acute myeloid leukemia (AML).
Who is leading the clinical trial?
Dr. Abhishek Maiti, an assistant professor at The University of Texas MD Anderson Cancer Center, is the lead investigator for the trial.
What are the primary measures of the trial?
The primary outcome measures include the incidence of adverse events, overall response rate, and complete response rates among others.
Where will the trial's results be presented?
The results will be presented at the American Society of Clinical Oncology Annual Meeting in Chicago.
How does CERo’s approach differ from existing therapies?
CERo's approach aims to engage both innate and adaptive immunity, potentially spanning applications beyond current CAR-T therapies.
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