dm+d

Unassigned

New Medicines

Relapsed or refractory multiple myeloma (MM) to >2 prior treatment regimens, including an IMiD (e.g. lenalidomide or pomalidomide), a proteasome inhibitor (e.g. bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g. daratumumab)

Information

New molecular entity
Novartis
Novartis

Development and Regulatory status

None
None
Phase I Clinical Trials

Category

Autologous CD19-directed CAR-T cell therapy developed using the T-Charge platform. The manufacturing process allows for in vivo expansion providing T cells with better ability to self-renew and proliferate than first-generation CAR-T cell therapies. [1,2]
The incidence in Europe of MM is 4.5-6.0 per 100,000 per year with a mortality rate of 4.1 per 100,000 per year [5].
Relapsed or refractory multiple myeloma (MM) to >2 prior treatment regimens, including an IMiD (e.g. lenalidomide or pomalidomide), a proteasome inhibitor (e.g. bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g. daratumumab)
Intravenous infusion

Trial or other data

Dec 21Early data from multicentre PI study (NCT04318327, n=40) shows promising results in 15 pts with r/r/ MM who received a single treatment of PHE885 at two dose levels (either 2.5×106 (n=4), 5×106 (n=10) and 14.3×106 CAR-T cells (n=1)). Although the follow-up period was brief (median 3.5 months), PHE885 showed best overall response of 100% for either dose, with responses deepening over time and with 8 of 15 pts with ongoing responses at the time of data cutoff. Of the evaluable pts at 3 months, 34% (2/6) were MRD-negative by next-generation sequencing (NGS) at 10-6; 43% (3/7) were MRD-negative at 10-5. All pts experienced CRS with 2 experiencing grade ≥3 CRS. No pts experienced grade 4 or 5 CRS. All neurotoxicity events (n=4) were non-serious, grade 1-2, reversible, and temporally associated with CRS. Recruitment for this trial is ongoing with data expected 2024. [1-4]