- CERo Therapeutics Holdings (CERO, Financial) is set to present its lead program, CER-1236, at the ASCO 2025 Annual Meeting.
- The Phase 1/1b clinical trial of CER-1236 targets acute myeloid leukemia patients with relapsed/refractory disease or TP53 mutations.
- Primary outcome measures for the trial include adverse events, dose-limited toxicities, and overall response rate.
CERo Therapeutics Holdings, Inc. (CERO), an innovative company focused on immunotherapy, has announced its participation in the upcoming American Society of Clinical Oncology (ASCO) 2025 Annual Meeting. The event is scheduled to take place in Chicago from May 30 to June 3, 2025. During the meeting, CERo will present a poster titled 'First-in-human study of autologous chimeric engulfment receptor T-cell CER-1236 targeting TIM-4-L in acute myeloid leukemia (CertainT-1)'.
The company is initiating a Phase 1/1b clinical trial to assess the safety and early efficacy of CER-1236, its novel immunotherapy drug for acute myeloid leukemia. This trial is specifically designed for patients with relapsed or refractory leukemia, those with measurable residual disease, or those possessing TP53 gene mutations.
The clinical trial will proceed in two phases. The first phase will involve dose escalation to determine the highest tolerable dose, followed by an expansion phase to evaluate the treatment's safety and efficacy. The primary outcomes to be measured in the trial include the incidence of adverse events (AEs) and serious adverse events (SAEs), dose-limited toxicities, overall response rate (ORR), complete response (CR), composite complete response (cCR), and measurable residual disease (MRD). Secondary outcomes will focus on pharmacokinetics (PK).
Chris Ehrlich, CEO of CERo Therapeutics, expressed anticipation for discussing the study protocol at ASCO, highlighting that CER-1236 leverages a unique approach by employing the patient's immune system to target cancer, potentially transforming current cancer therapy methodologies.
