FDA Clears IND for CT-0525 in Solid Tumors Overexpressing HER2


CT-0525 is an ex vivo gene-modified autologous CAR-monocyte cellular therapy being evaluated for the treatment of HER2-overexpressing solid tumors.

  • CT-0525 is the first chimeric antigen receptor (CAR)-Monocyte manufacturing platform to be assessed in humans in the solid tumor space.

  • Preclinical data of CT-0525 showed reduced tumor growth with the platform across multiple solid tumor models.

  • A phase 1 study evaluating the platform plans to begin in the coming months.

The FDA has cleared the investigational new drug (IND) application for CT-0525, an ex vivo gene-modified autologous CAR-monocyte cellular therapy for the treatment of HER2–overexpressing solid tumors.1

With this notification given by the FDA, a study may proceed. A phase 1 study plans to begin in the coming months with the first patient expected to be treated in the first half of 2024.

"Clearance of the IND for CT-0525 is a significant milestone in Carisma's mission to develop innovative myeloid cell therapies for metastatic solid tumors," said Steven Kelly, president and chief executive officer of Carisma, in a press release. “Through this phase 1 study, we aim to advance our understanding of safety, tolerability, manufacturing feasibility, and mechanism of action of CT-0525."

With the CAR-Monocyte manufacturing platform, there is the ability to manufacture up to 10 billion cells from a single apheresis. It utilizes a rapid, single-day manufacturing process which can potentially reduce the cost of goods and manufacturing turnaround time associated with this autologous cell therapy.

CT-0525 is the first CAR-Monocyte to be evaluated in humans with solid tumors. Pre-clinical data of CT-0525 therapy were presented at the Society for Immunotherapy of Cancer's Annual Meeting in November 2022 and showed that with the platform, tumor growth was reduced across multiple preclinical solid tumor models.

The planned phase 1 study will evaluate the safety, tolerability, and the manufacturing feasibility of CT-0525 in patients with locally advanced or metastatic solid tumors overexpressing HER2. Patients must have disease that progressed on standard approved therapies, and the trial will include 2 cohorts.

In cohort 1, patients will receive up to 3 billion CAR-positive cells via intravenous (IV) administration. Cohort 2 will be given IV administration of CT-0525 of up to 10 billion CAR-positive cells.

"CT-0525 is the first CAR-Monocyte to be evaluated in the solid tumor setting. With a CAR-Monocyte's in vivo persistence, ability to differentiate into pro-inflammatory CAR macrophages, and multi-modal antitumor mechanism of action, along with its high cell yield, CT-0525 has the potential to improve the treatment paradigm for patients with HER2 overexpressing metastatic solid tumors," said Michael Klichinsky, PharmD, PhD, co-founder and chief scientific officer at Carisma, in a press release. "We look forward to the clinical development of CT-0525."

Carisma Therapeutics announces FDA clearance of IND application for CT-0525, a novel HER2-targeting CAR-monocyte. News release. Carisma Therapeutics Inc. November 28, 2023. Accessed November 28, 2023. https://tinyurl.com/ycxkbfbt
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