FDA Clears IND Application for CER-1236 in Advanced Solid Tumors

US FDA

• The FDA has cleared a second investigational new drug (IND) application for CER-1236 in advanced solid tumors.
• CER-1236 is a novel chimeric antigen receptor (CAR) T-cell therapy.
• A phase 1 trial will evaluate the agent as a potential treatment for patients with advanced solid tumors, including non–small cell lung cancer (NSCLC) and ovarian cancer.

The FDA has granted clearance for a second IND application for CER-1236 in advanced solid tumors, specifically NSCLC and ovarian cancer.¹ A second phase 1 clinical trial of the agent will be initiated.

“Following the launch of our AML trial, we are now starting a second clinical study of CER-1236 to evaluate its potential in solid tumors and bring new therapeutic options to patients with ovarian and lung cancer,” said Robert Sikorski, MD, PhD, chief medical officer of CERo, in a press release. “CER-1236 is novel: the first CAR T-cell therapy to target Tim-4L and the first with phagocytic activity programmed into a T-cell. Preclinical data suggest that this dual mechanism may help overcome key resistance barriers that have hampered solid tumor CAR T trials.”

CER-1236 is a novel CAR T-cell therapy that works by targeting Tim-4L and incorporates programmed phagocytic activity in T cells. Preclinical studies demonstrated CER-1236's antitumor activity against ovarian cancer cells with no observed toxicity. Post-infusion analyses revealed successful T-cell engraftment in lymphoid tissues without adverse effects on clinical pathology, histopathology, or in-life observations.¹

The FDA's second IND clearance for CER-1236 builds on its initial acute myeloid leukemia (AML) authorization, with phase 1 evaluation in relapsed/refractory AML remaining on schedule to dose the first patient in the first half of 2025.²

This first-in-human, multicenter, open-label, phase 1/1b study will assess the safety and preliminary efficacy of CER-1236 in patients with relapsed/refractory measurable residual disease (MRD)-positive AML. The study will consist of 2 parts: a dose-escalation phase to establish the maximum tolerated dose and recommended phase 2 dose, followed by a dose-expansion phase to further evaluate the agent’s safety and efficacy.

The primary end points of the study include incidence of adverse events and serious adverse events, incidence of dose-limiting toxicities, overall response rate, complete response, composite complete response, and MRD. Pharmacokinetics is a secondary end point of the study.

“The FDA’s collaborative role has been critical to maintaining development velocity and enabling us to operate two open trials in both hematologic and solid tumors. Taken together, this expansion reflects our belief in the therapeutic breadth and the commercial and partnering potential of CER-1236,” stated Sikorski in the press release.¹

“Of note, our team has been simultaneously progressing our phase 1 AML trial in the US.Their incredible efforts cannot be under-emphasized, and I wish to convey my gratitude to our extremely competent and efficient team. We are looking forward to sharing progress on each of our two phase 1 clinical trials in the near term,” added Chris Ehrlich, CERo chief executive officer, in the press release.

References:

1. CERo Therapeutics Holdings, Inc. Receives FDA Clearance of Second Investigational New Drug Application to Initiate Phase 1 Clinical Trial of Lead Compound CER-1236 in Solid Tumors. News release. CERo Therapeutics Holdings, Inc. March 31, 2025. Accessed March 31, 2025. https://tinyurl.com/9xjra2z8

2. CERo Therapeutics Holdings, Inc. poised to initiate enrollment of phase 1 trial of CER-1236 in AML following positive FDA review of manufacturing. News release. CERo Therapeutics Holdings, Inc. March 27, 2025. Accessed March 31, 2025. https://tinyurl.com/mr36xu7s