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Carisma Therapeutics’ solid tumour therapy obtains FDA Fast Track status

2024-06-26

快速通道临床1期基因疗法细胞疗法

Participants with unresectable or metastatic solid tumours that overexpress HER2 will be part of the Phase I trial. Credit: Vink Fan via Shutterstock.

The US Food and Drunresectable or metastatic solid tumours Track designationHER2 Carisma Therapeutics’ CT-0525 for the treatment of solid tumours overexpressing human epidermal growth factor receptor 2 (HER2).

An ex vivo gene-modified autologous chimeric antigen receptor-monocyte cellular therapy, CT-0525 is being analysed in a Phase I clinical trial.

The opeFood and Drug Administration (FDA)s the safety, tolerability, and manufactCarisma Therapeutics tCT-0525apy.solid tumours human epidermal growth factor receptor 2 (HER2)

Participants enrolled in the trial will include those with locally advanced (unresectableCT-0525tastatic solid tumours that overexpress HER2 and have advanced following treatment with standard therapies approved presently.

The trial will also feature two dose escalation cohorts to determine the optimal dose of CT-0525.

See Also:AstraZeneca’s Tagrisso receives approval in Japan locally advanced (unresectable) or metastatic solid tumours HER2

AstraZeneca’s Truqap and Faslodex combo receives approval in EUCT-0525

With the AstraZenecaFDA Fast Track status, CT-0525 is now poiselung cancercelerated review process.

Carisma Therapeutics CMO Eugene Kennedy said: “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.

AstraZenecamitTruqap workFaslodexely with the FDA to accelerate the development of CT-0525. Currently, we are enrolling patients in the Phase I clinical trial and remain on track to report initial clinical data by the end of 2024.”

This designation is a significant milestone, intended to expedite the development and review of therapies for serious conditions with unmet medical needs.

In 2022, Carisma TheFDAeutics and Sesen BioCT-0525 a definitive merger agreement to combine businesses and create a clinical-stage biotechnology company in an all-stock deal.

Carisma Therapeuticscoverage on Pharmaceutical Technology is supported by Cytiva.CT-0525 FDA FDA malignancies CT-0525

Editorial content is independently produced anFDAollows the highest standards of joCT-0525tic integrity. Topic sponsors are not involved in the creation of editorial content.

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