PHE885 CAR-T Therapy in Adult Participants With Relapsed and Refractory Multiple Myeloma

Active:	No
Cancer Type:	Multiple Myeloma	NCT ID:	NCT05172596
Trial Phases:	Phase II	Protocol IDs:	CPHE885B12201 (primary) NCI-2022-04181 2021-003747-22
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Novartis Pharmaceuticals Corporation
NCI Full Details:	http://clinicaltrials.gov/show/NCT05172596

Summary

This is a Phase II study to determine the efficacy and safety of PHE885, a BCMA-directed
CAR-T cell therapy, manufactured with a new process. The CAR-T cell therapy will be
investigated as a single agent in relapsed and refractory multiple myeloma

Objectives

This clinical trial employs an open label, single arm, multi-center design with primary
analysis testing overall response rate ( ORR), including one interim analysis for
futility and one interim analysis for efficacy.

The trial population includes adult patients with relapsed and refractory multiple
myeloma (MM) after failure of 3 or more lines of therapy, including failing an
immunomodulatory drug (IMiD), a proteasome inhibitor (PI) and an anti-CD38 (cluster of
differentiation 38) monoclonal antibody (mAb) and who have measurable disease at
enrollment per IMWG criteria . In addition, patients must be refractory to the last line
of therapy

The trial will enroll 90 efficacy evaluable adult patients with relapsed and refractory
MM (efficacy evaluable means participants infused with a PHE885 product at target dose
10e6 that met all release specifications).

Patients will be followed for acute and intermediate safety and efficacy within this
trial for a minimum of 2 years before being transferred to the long-term follow-up trial.
A long-term post-study follow-up for lentiviral vector safety will be offered under a
separate destination protocol for 15 years post injection per health authority
guidelines.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.