FDA clears IND for Calidi's CLD-101 Phase 1b/2 trial in high-grade glioma

Calidi Biotherapeutics, Inc.

FDA cleared Northwestern University's IND for CLD-101, a stem cell-based oncolytic virus therapy for high-grade glioma.
Phase 1b/2 trial will evaluate safety/feasibility of multiple doses in newly diagnosed patients; expected to start Q1 2025.
Prior Phase 1 trial showed median overall survival 18.4 months and no dose-limiting toxicity (Lancet Oncology 2021).
Additional Phase 1 trial in recurrent high-grade glioma at City of Hope with interim data expected H1 2025.

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