CERo Therapeutics Provides Clinical Update on Phase 1 Trial of CER-1236 in AML
Date: January 07, 2026 | Source: GlobeNewsWire
Summary of the Clinical Update
CERo Therapeutics Holdings, Inc. (OTCQB: CERO) announced significant progress in its ongoing Phase 1 CertainT-1 trial focused on acute myeloid leukemia (AML). Following the completion of the dose-limiting toxicity (DLT) observation period, investigators reported successful cell expansion with no instances of cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), or any treatment-related adverse events observed to date. This promising result was noted with or without lymphodepletion.
Key Findings from the CertainT-1 Trial
The second patient enrolled in the trial, who is battling myelodysplastic syndrome (MDS) that progressed to AML, received four rounds of CER-1236 treatment. Remarkably, a 61-day platelet transfusion-free interval was achieved, surpassing the commonly referenced 8-week benchmark for platelet transfusion independence in clinical studies.
This transfusion independence ended after subsequent lymphodepleting chemotherapy combined with CER-1236 treatment.
Regulatory Amendments and Future Directions
CERo has submitted an amendment to the U.S. Food and Drug Administration (FDA) to expand the CertainT-1 trial. This amendment seeks to include additional cohorts for advanced MDS and myelofibrosis (MF) patients. The company aims to enhance the depth of its clinical assessments and broaden the therapeutic applications of the CER-1236 treatment.
Insights from the Leadership Team
Dr. Robert Sikorski, M.D., Ph.D., Chief Scientific Officer of CERo, expressed enthusiasm about the findings: “The patient’s clinical course, including a platelet transfusion–free interval despite having advanced MDS/AML, is encouraging and supports continued evaluation of CER-1236 in diseases of the bone marrow.”
CERo's CEO, Chris Ehrlich, highlighted the evolution of the trial, stating, “The evolution of this trial to MDS and MF is an important milestone as we continue to dose escalate.” The company remains committed to safe and effective trial conduct while valuing participation from trial patients and the support from loyal shareholders.
Upcoming Conference Call Details
An analyst call is scheduled for today, January 7, 2026, at 5:00 PM ET, where CERo will share further details regarding the trial progress and future strategies. Interested parties can participate by calling:
- 1-844-763-8274 (domestic)
- 1-412-717-9224 (international)
Participants are encouraged to call in approximately 10 minutes before the scheduled start time. A live webcast will also be available, and a replay of the call can be accessed until March 7, 2026.
About CERo Therapeutics Holdings, Inc.
CERo is at the forefront of immunotherapy, focusing on the development of next-generation engineered T cell therapeutics for cancer treatment. Their proprietary T cell engineering approach merges innate and adaptive immunity in a unique therapeutic construct designed to enhance the body's immune response against tumors.
The firm's lead product candidate, CER-1236, targets hematologic malignancies and reflects CERo’s commitment to pioneering innovative solutions in cellular immunotherapy.
Forward-Looking Statements
This communication may contain forward-looking statements about CERo's strategies, future operations, and potential outcomes. Such statements involve risks and uncertainties, and actual results may differ from those projected.