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

NCT05172596 | Terminated Phase 2 DMC FDA Drug

• 2 other identifiers: CPHE885B122012021-003747-22
• Study Type: interventional
• Target: 146
• Locations: 14 countries
• Sites: 36

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

Conditions

Multiple Myeloma

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Overall response rate (ORR) per Independent Review Committee (IRC) in Efficacy Analysis Set

  Percentage of patients with best overall response (BOR) of either stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR) according to the International Myeloma Working Group (IMWG) criteria'

  24 Months

Secondary Outcomes (18)

• Key Secondary End point: MRD Negativity rate in Bone Marrow

  24 months

• Complete response rate (CRR)

  24 Months

• Time to response

  24 Months

• Duration of Response (DOR)

  24 Months

• Progression free survival (PFS)

  24 Months

Study Arms (1)

PHE885

EXPERIMENTAL

Patients will receive PHE885

Biological: PHE885

Interventions

PHE885 BIOLOGICAL

Intravenous (IV) infusion

PHE885

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥18 years of age at the time of informed consent form (ICF) signature
• 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)
• \. Must be refractory to the last treatment regimen (defined as progressive disease on or within 60 days measured from last dose of last regimen).
• \. 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

You may not qualify if:

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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (36)

Stanford University

Palo Alto, California, 94304, United States

Location

Emory University School of Medicine-Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

Oregon Health Sciences University

Portland, Oregon, 97239, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Fred Hutch Cancer Research

Seattle, Washington, 98109, United States

Location

Novartis Investigative Site

Camperdown, New South Wales, 2050, Australia

Location

Novartis Investigative Site

Melbourne, Victoria, 3004, Australia

Location

Novartis Investigative Site

Salvador, Estado de Bahia, 41253-190, Brazil

Location

Novartis Investigative Site

São Paulo, São Paulo, 01509-900, Brazil

Location

Novartis Investigative Site

Calgary, Alberta, T2N 5G2, Canada

Location

Novartis Investigative Site

Lille, 59037, France

Location

Novartis Investigative Site

Nantes, 44093, France

Location

Novartis Investigative Site

Paris, 75475, France

Location

Novartis Investigative Site

Poitiers, 86021, France

Location

Novartis Investigative Site

Würzburg, Bavaria, 97080, Germany

Location

Novartis Investigative Site

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Novartis Investigative Site

Hamburg, 20246, Germany

Location

Novartis Investigative Site

Heidelberg, 69120, Germany

Location

Novartis Investigative Site

Athens, 106 76, Greece

Location

Novartis Investigative Site

Thessaloniki, 570 10, Greece

Location

Novartis Investigative Site

Ramat Gan, 5265601, Israel

Location

Novartis Investigative Site

Tel Aviv, 6423906, Israel

Location

Novartis Investigative Site

Bologna, BO, 40138, Italy

Location

Novartis Investigative Site

Milan, MI, 20133, Italy

Location

Novartis Investigative Site

Nagoya, Aichi-ken, 4678602, Japan

Location

Novartis Investigative Site

Sapporo, Hokkaido, 060 8648, Japan

Location

Novartis Investigative Site

Kyoto, Kyoto, 602-8566, Japan

Location

Novartis Investigative Site

Sendai, Miyagi, 980 8574, Japan

Location

Novartis Investigative Site

Riyadh, 11211, Saudi Arabia

Location

Novartis Investigative Site

Singapore, 119074, Singapore

Location

Novartis Investigative Site

Singapore, 169608, Singapore

Location

Novartis Investigative Site

Pamplona, Navarre, 31008, Spain

Location

Novartis Investigative Site

Salamanca, 37007, Spain

Location

Novartis Investigative Site

Glasgow, Scotland, G51 4TF, United Kingdom

Location

Novartis Investigative Site

Birmingham, West Midlands, B15 2TH, United Kingdom

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: December 29, 2021
• Study Start: March 3, 2022
• Primary Completion: May 21, 2025
• Study Completion: May 21, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

GR (2); SG (2); BR (2); IT (2); US (6); ES (2); FR (4); GB (2); CA (1); IL (2); AU (2); SA (1); JP (4); DE (4)