CT-0525 Gains FDA Fast Track Designation in HER2-Overexpressing Solid Tumors

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CT-0525 has received a fast track designation from the FDA for the treatment of solid tumors that overexpress HER2.

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  • The FDA has granted a fast track designation to CT-0525 for treating HER2-overexpressing solid tumors.
  • CT-0525 is an ex vivo, gene-modified, autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress HER2.
  • A phase 1 trial (NCT06254807) is now evaluating CT-0525 in patients with a HER2-overexpressing solid tumor.

CT-0525, an ex vivo, gene-modified, autologous CAR-monocyte cell therapy, has been granted a fast track designation from the FDA for the treatment of solid tumors that overexpress HER2.

An open-label, phase 1 trial is now evaluating the safety, tolerability, and manufacturing feasibility of CT-0525 in patients with locally advanced or metastatic solid tumors overexpressing HER2.

This study marks the first CAR-monocyte to be evaluated in humans in the solid tumor setting.2

Tumor cell being attacked - Generated with Google Gemini AI

Tumor cell being attacked - Generated with Google Gemini AI

"Receiving fast track designation for CT-0525 from the FDA marks a significant milestone for Carisma, highlighting the FDA's recognition of the serious and life-threatening nature of these malignancies and the potential of CT-0525 to meet this critical medical need," said Eugene P. Kennedy, MD, chief medical officer of Carisma, in a press release.1 "We are committed to working closely with the FDA to accelerate the development of CT-0525. Currently, we are enrolling patients in the phase 1 clinical trial and remain on track to report initial clinical data by the end of 2024."

In the study of CT-0525, enrollment is open to patients aged 18 years and older with locally advanced or metastatic solid tumors that overexpress HER2 and whose disease has progressed on standard approved therapies are eligible for enrollment in the study.3 Other requirements include having at least 1 measurable lesion, an ECOG performance status of 0 to 1 at screening, adequate cardiac function, adequate hepatic function, and an O2 saturation > 85%.

Two dose-escalation cohorts will make up the study. In cohort 1, 3 patients will be treated with a single intravenous (IV) administration of CT-0525 at a dose of 3 billion CAR-positive cells given on day 1. Cohort 2 will enroll 3 patients who will be given a single IV administration of CT-0525 at 10 billion CAR-positive cells, also on day 1. In May 2024, the first patient with a solid tumor overexpressing HER2 was dosed in the study.2

Evaluating the safety and tolerability of CT-0525 by estimating the frequency and severity of adverse events in patients with HER2-overexpressing solid tumors and to assess the feasibility of manufacturing CT-0525 serve as end points of the trial.

Patients are being recruited in Ohio. Further, the estimated study completion date is March 31, 2026.

REFERENCES:
1. Carisma Therapeutics granted FDA fast track designation for CT-0525 for the treatment of HER2-overexpressing solid tumors. News release. Carisma Therapeutics Inc. June 25, 2024. Accessed June 25, 2024. https://tinyurl.com/38awj695
2. Carisma Therapeutics announces first patient dosed in phase 1 clinical trial of CT-0525, a novel HER2-targeting CAR-monocyte. News release. Carisma Therapeutics Inc. May 16, 2024. Accessed June 25, 2024. https://tinyurl.com/3m886ycz
3. CAR-monocytes for the treatment of HER2 overexpressing solid tumors. ClinicalTrial.gov. Updated April 11, 2024. Accessed May 19, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT06254807
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