BMS-986393

P3, N=440, Not yet recruiting, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

P2, N=150, Recruiting, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Not yet recruiting --> Recruiting

P2, N=150, Not yet recruiting, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

P1, N=111, Recruiting, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company | Not yet recruiting --> Recruiting

P1, N=180, Active, not recruiting, Juno Therapeutics, a Subsidiary of Celgene | Recruiting --> Active, not recruiting

P1, N=111, Not yet recruiting, Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

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.

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.

Dose escalation of BMS-986393 from 25 through 450 × 10 6 CAR T cells has not exceeded the MTD at the time of data cutoff. Observed CRS was mostly G1/2. ICANS-type neurotoxicity was infrequent, low-grade, and reversible.

After screening and leukapheresis, pts received bridging therapy if needed, then lymphodepleting chemotherapy (fludarabine 30 mg/m2 + cyclophosphamide 300 mg/m2 daily for 3 days) followed by a single infusion of BMS-986393... At all tested dose levels, BMS-986393 demonstrated a favorable safety profile; both CRS and neurotoxicity were low-grade, and neurotoxicity was infrequent and short-lived. Dose escalation is ongoing; MTD has not been exceeded. Preliminary efficacy appeared promising; antitumor responses were observed, including pts with CR who were MRD-negative at month 3.