This is a first-in-human study to evaluate the feasibility, safety and preliminary antitumor efficacy of autologous T cells genetically engineered with a novel B-cell Maturation Antigen (BCMA)-specific chimeric antigen receptor (CAR) and manufactured with a new process. CAR-T cells will be investigated as a single agent in relapsed/refractory multiple myeloma.
This trial is currently open and accepting patients.
The following criteria is a partial list of reasons why patients may be eligible to participate in this clinical trial. Further evaluation with a medical professional is required.
Enrollment: 46 patients (estimated)View More
December 13, 2021
PHE885, an investigational, autologous BCMA-directed CAR-T cell therapy developed using the T-Charge platform, demonstrated promising results in patients with relapsed or refractory multiple myeloma in a first-in-human Phase I, multicenter, dose-escalation study. Fifteen patients were evaluated for efficacy and safety and the fixed doses received were 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, PHE885 shows encouraging initial clinical activity with a best overall response of 100% for patients receiving the 5×106 or 14.3×106 CAR-T cell dose, with responses deepening over time. With a median follow-up of 3.5 months, eight of 15 patients had ongoing responses at the time of data cutoff. Of the evaluable patients at three months post administration, 34% (2/6) were MRD-negative by next-generation sequencing (NGS) at 10-6; 43% (3/7) were MRD-negative at 10-5.
All patients experienced CRS with two patients experiencing grade ≥3 CRS. No patients experienced grade 4 or 5 CRS. All neurotoxicity events (n=4) were nonserious, grade 1-2, reversible, and temporally associated with CRS.
View all clinical trial locations sorted by state.
If you are interested in keeping an eye on this trial, you can add it to your list of favorite trials. We'll send you alerts when this trial is updated.
You can explore trial locations from around the US and connect directly with a trial coordinator.Find Nearby Locations
You can print an overview of this trial to take in to your next appointment. Your doctor can help you understand if this trial may be right for you.
Still need help? Send us a message