CAR-T Cell Therapy for Multiple Myeloma

Recruiting in Palo Alto (17 mi)

+12 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Novartis Pharmaceuticals

No Placebo Group

Trial Summary

What is the purpose of this trial?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 multiple myeloma

Eligibility Criteria

This trial is for adults with Multiple Myeloma who've had at least two prior treatments, including specific drugs like IMiDs and proteasome inhibitors. They should have a performance status of 0 or 1 if previously treated, or up to 2 if newly diagnosed after standard therapy. Participants must not have had any genetic cell therapies before, nor certain cancer treatments close to joining the study.

Inclusion Criteria

You have a condition that can be measured according to the study's guidelines.

My leukapheresis material is approved for use.

My blood test results are within normal ranges.

+4 more

Exclusion Criteria

I have previously received a genetic cell therapy but not BCMA-directed bi-specific antibodies or ADC.

I haven't had chemotherapy or other cancer treatments except for LD chemotherapy in the last 2 weeks.

I have had my own stem cell transplant within the last 6 weeks or have never had a stem cell transplant from a donor.

+2 more

Participant Groups

The trial tests PHE885, a new type of CAR-T cell therapy targeting BCMA on myeloma cells. It's a first-in-human study assessing how safe it is and its initial effectiveness against multiple myeloma as a single agent treatment.

2Treatment groups

Experimental Treatment

Group I: PHE885 (Part B)Experimental Treatment1 Intervention

Newly diagnosed multiple myeloma (NDMM) patients will receive PHE885.

Group II: PHE885 (Part A)Experimental Treatment1 Intervention

Relapsed and/or refractory multiple myeloma (r/r MM) patients will receive PHE885.