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

NCT ID: NCT05172596

Last Updated: 2025-11-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2025-05-21

Brief 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

Detailed Description

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.

Conditions

Multiple Myeloma

Keywords

Multiple myeloma; B-cell maturation antigen; BCMA; BCMA-directed; chimeric antigen receptor; CAR-T; PHE885

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PHE885

Patients will receive PHE885

Group Type: EXPERIMENTAL

PHE885

Intervention Type: BIOLOGICAL

Intravenous (IV) infusion

Interventions

PHE885

Intravenous (IV) infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. ≥18 years of age at the time of informed consent form (ICF) signature

2. Adult patients after failure of three or more lines of therapy including an IMiD (e.g., lenalidomide or pomalidomide), a proteasome inhibitor (e.g., bortezomib, carfilzomib), and an approved anti-CD38 antibody (e.g., daratumumab, isatuximab), and who have documented evidence of disease progression (IMWG criteria) 3, Must have received ≥2 consecutive cycles of treatment for at least three prior regimens unless deemed refractory to that regimen (i.e., progressive disease as the best response)

4. Must be refractory to the last treatment regimen (defined as progressive disease on or within 60 days measured from last dose of last regimen).

5. Measurable disease at enrollment as defined by the protocol 6. Eastern Cooperative Oncology Group (ECOG) performance status that is either 0 or 1 at screening 7. Must have a leukapheresis material of non-mobilized cells accepted for manufacturing

Exclusion Criteria

1.Prior administration of a genetically modified cellular product including prior BCMA CAR-T therapy. 2.Participants who have received prior BCMA -directed bi-specific antibodies or anti-BCMA antibody drug conjugate.

3. Prior autologous SCT within 3 month or allogenic SCT within 6 months prior to signing informed consent.

4.Plasma cell (PC) leukemia and other plasmacytoid disorders, other than MM 5.POEMS syndrome 6.Active central nervous system (CNS) involvement by malignancy 7.Patients with active neurological autoimmune or inflammatory disorders 8.Inadequate cardiac, renal, hepatic or hematologic function as defined in the protocol.

Other protocol-defined Inclusion/Exclusion may apply.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Stanford University

Palo Alto, California, United States

Emory University School of Medicine-Winship Cancer Institute

Atlanta, Georgia, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Oregon Health Sciences University

Portland, Oregon, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Fred Hutch Cancer Research

Seattle, Washington, United States

Novartis Investigative Site

Camperdown, New South Wales, Australia

Novartis Investigative Site

Melbourne, Victoria, Australia

Novartis Investigative Site

Salvador, Estado de Bahia, Brazil

Novartis Investigative Site

São Paulo, São Paulo, Brazil

Novartis Investigative Site

Calgary, Alberta, Canada

Novartis Investigative Site

Lille, , France

Novartis Investigative Site

Nantes, , France

Novartis Investigative Site

Paris, , France

Novartis Investigative Site

Poitiers, , France

Novartis Investigative Site

Würzburg, Bavaria, Germany

Novartis Investigative Site

Cologne, North Rhine-Westphalia, Germany

Novartis Investigative Site

Hamburg, , Germany

Novartis Investigative Site

Heidelberg, , Germany

Novartis Investigative Site

Athens, , Greece

Novartis Investigative Site

Thessaloniki, , Greece

Novartis Investigative Site

Ramat Gan, , Israel

Novartis Investigative Site

Tel Aviv, , Israel

Novartis Investigative Site

Bologna, BO, Italy

Novartis Investigative Site

Milan, MI, Italy

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Kyoto, Kyoto, Japan

Novartis Investigative Site

Sendai, Miyagi, Japan

Novartis Investigative Site

Riyadh, , Saudi Arabia

Novartis Investigative Site

Singapore, , Singapore

Novartis Investigative Site

Singapore, , Singapore

Novartis Investigative Site

Salamanca, Castille and León, Spain

Novartis Investigative Site

Pamplona, Navarre, Spain

Novartis Investigative Site

Glasgow, Scotland, United Kingdom

Novartis Investigative Site

Birmingham, , United Kingdom

Countries

United States; Australia; Brazil; Canada; France; Germany; Greece; Israel; Italy; Japan; Saudi Arabia; Singapore; Spain; United Kingdom

Other Identifiers

2021-003747-22

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CPHE885B12201

Identifier Type: -

Identifier Source: org_study_id