Multiple Myeloma Clinical Trial

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

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

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Full 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.

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Eligibility Criteria

Inclusion Criteria:

≥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, treatment-a-promising-new-option-for-relapsed-multiple-myeloma/" >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.

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

136

Study ID:

NCT05172596

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 38 Locations for this study

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Stanford University .
Palo Alto California, 94304, United States
Emory University School of Medicine/Winship Cancer Institute
Atlanta Georgia, 30322, United States
Dana Farber Cancer Institute Main Site
Boston Massachusetts, 02215, United States
Oregon Health Sciences University .
Portland Oregon, 97239, United States
Thomas Jefferson University .
Philadelphia Pennsylvania, 19107, United States
Fred Hutch Cancer Research
Seattle Washington, 98109, United States
Novartis Investigative Site
VIC Melbourne, 3004, Australia
Novartis Investigative Site
Camperdown New South Wales, 2050, Australia
Novartis Investigative Site
Salvador BA, 41253, Brazil
Novartis Investigative Site
Sao Paulo SP, 01323, Brazil
Novartis Investigative Site
São Paulo SP, 01509, Brazil
Novartis Investigative Site
Calgary Alberta, T2N 4, Canada
Novartis Investigative Site
Lille , 59037, France
Novartis Investigative Site
Nantes Cedex 1 , 44093, France
Novartis Investigative Site
Paris 10 , 75475, France
Novartis Investigative Site
Poitiers , 86021, France
Novartis Investigative Site
Hamburg , 20246, Germany
Novartis Investigative Site
Heidelberg , 69120, Germany
Novartis Investigative Site
Koeln , 50937, Germany
Novartis Investigative Site
Wuerzburg , 97080, Germany
Novartis Investigative Site
Thessaloniki GR, 570 1, Greece
Novartis Investigative Site
Athens , 106 7, Greece
Novartis Investigative Site
Ramat Gan , 52621, Israel
Novartis Investigative Site
Tel Aviv , 64239, Israel
Novartis Investigative Site
Bologna BO, 40138, Italy
Novartis Investigative Site
Milano MI, 20133, Italy
Novartis Investigative Site
Nagoya-city Aichi, 467-8, Japan
Novartis Investigative Site
Sapporo city Hokkaido, 060 8, Japan
Novartis Investigative Site
Kyoto-city Kyoto, 602-8, Japan
Novartis Investigative Site
Sendai city Miyagi, 980 8, Japan
Novartis Investigative Site
Riyadh , 11211, Saudi Arabia
Novartis Investigative Site
Singapore , 11922, Singapore
Novartis Investigative Site
Singapore , 16960, Singapore
Novartis Investigative Site
Salamanca Castilla Y Leon, 37007, Spain
Novartis Investigative Site
Pamplona Navarra, 31008, Spain
Novartis Investigative Site
Birmingham , B15 2, United Kingdom
Novartis Investigative Site
Glasgow , G51 4, United Kingdom
Novartis Investigative Site
Manchester , M20 4, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Myeloma

Phase:

Phase 2

Estimated Enrollment:

136

Study ID:

NCT05172596

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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