P1, N=180, Active, not recruiting, Juno Therapeutics, a Subsidiary of Celgene | Trial completion date: Jun 2025 --> Dec 2025 | Trial primary completion date: Jun 2025 --> Dec 2025
5 months ago
Trial completion date • Trial primary completion date
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cyclophosphamide • bendamustine • fludarabine IV • arlocabtagene autoleucel (BMS-986393)
P2, N=150, Recruiting, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Trial completion date: Jun 2030 --> Jun 2032 | Trial primary completion date: Oct 2026 --> Jun 2027
11 months ago
Trial completion date • Trial primary completion date
In this first-in-human study, BMS-986393 showed a manageable safety profile and deep and durable responses, including MRD negativity, at all tested dose levels, including in pts refractory to prior BCMA-directed therapies. CRS and ICANS-type neurotoxicity were mostly low-grade, with increased G ≥ 3 events at the 300 and 450 × 106 CAR T‑cell doses. On-target off-tumor TRAEs, all G1/2, occurred in a minority of pts.
2 years ago
P1 data • IO biomarker
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GPRC5D (G Protein-Coupled Receptor Class C Group 5 Member D)
As of data cutoff, dose escalation of BMS-986393 from 25–450 × 10⁶ CAR T cells did not exceed MTD. CRS was mostly G1/2. ICANS-type neurotoxicity was infrequent, low-grade and reversible.
2 years ago
P1 data • CAR T-Cell Therapy • IO biomarker
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GPRC5D (G Protein-Coupled Receptor Class C Group 5 Member D)