Carisma Says FDA Grants Fast Track Designation For CT-0525 In HER2-Overexpressing Solid Tumors

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Carisma Says FDA Grants Fast Track Designation For CT-0525 In HER2-Overexpressing Solid Tumors

(RTTNews) - Biopharmaceutical company Carisma Therapeutics, Inc. (CARM) announced Tuesday that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CT-0525, an ex vivo gene-modified autologous chimeric antigen receptor-monocyte (CAR-Monocyte) cellular therapy intended to treat solid tumors that overexpress human epidermal growth factor receptor 2 (HER2).

The Phase 1 clinical trial for CT-0525 is an open-label study designed to assess the safety, tolerability, and manufacturing feasibility of CT-0525.

This trial will enroll participants with locally advanced (unresectable) or metastatic solid tumors overexpressing HER2 whose disease has progressed on standard approved therapies. The initial study design will consist of two dose escalation cohorts.

Carisma said it is looking to work closely with the FDA to accelerate the development of CT-0525. It is currently enrolling patients in the Phase 1 clinical trial and remains on track to report initial clinical data by the end of 2024.

Teg: CARM
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PERINGATAN RISIKO TINGGI: Perdagangan pertukaran mata wang asing mempunyai risiko tinggi yang mungkin tidak sesuai untuk semua jenis pelabur. Leveraj menimbulkan risiko dan kerugian tambahan. Sebelum anda memutuskan untuk berdagang pertukaran mata wang asing, pertimbangkan dengan teliti objektif pelaburan, tahap pengalaman dan toleransi risiko anda. Anda berkemungkinan kehilangan sebahagian atau semua pelaburan awal anda. Jangan melaburkan wang yang anda tidak mampu untuk kehilangan. Didik diri anda tentang risiko yang berkaitan dengan perdagangan pertukaran asing, dan dapatkan nasihat daripada penasihat bebas kewangan atau cukai jika anda mempunyai sebarang pertanyaan mengenainya. Semua data dan maklumat yang disediakan adalah semata-mata untuk tujuan maklumat, dan bukan bertujuan untuk tujuan perdagangan atau nasihat. Prestasi masa lalu tidak semestinya menunjukkan hasil masa depan.