PHE885 CAR-T Therapy in Adult Participants With Relapsed and Refractory Multiple Myeloma
*The trial information contained on this page was imported from ClinicalTrials.gov. Click here to view this trial on ClinicalTrials.gov.
- Full Title:
- A Phase 2 Study of PHE885, B-cell Maturation Antigen (BCMA)- Directed CAR-T Cells in Adult Participants With Relapsed and Refractory Multiple Myeloma.
- Myeloma stage or condition:
- Multiple Myeloma
- Study phase:
- Phase 2
- Summary/Purpose:
- 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.
- Treatments:
- Biological : PHE885
Intravenous (IV) infusion
- Study Arms:
- Experimental : PHE885
Patients will receive PHE885
- Study Type:
- Interventional
- Study Design:
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Treatment
- Masking: None (Open Label)
- Recruitment status:
- Recruiting
- 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
-
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.
- Locations / Centres:
-
Novartis Investigative Site, Calgary, Alberta – Active, not recruiting
- Contacts:
- Name: Novartis Pharmaceuticals
Phone: 1-888-669-6682
Email: [email protected]
- Publications:
- ???
- First posted:
- 2021-12-29
- Actual start date:
- March 7, 2022
- Last updated:
- 2024-05-02
- Estimated enrollment:
- 136
- Estimated completion date:
- 2025-12-16
- Estimated primary completion date:
- 2025-12-16
- Condition:
- Multiple Myeloma
- Gender:
- All
- Ages:
- 18 Years-N/A
- Accepts healthy volunteers:
- No
- Listed location countries:
- Australia
- Brazil
- Canada
- France
- Germany
- Greece
- Israel
- Italy
- Japan
- Saudi Arabia
- Singapore
- Spain
- United Kingdom
- United States
- NCT number:
- NCT05172596
- Other study ID numbers:
- CPHE885B12201
- Has Data monitoring committee:
- Yes
- U.S. FDA-regulated product:
- Yes
- IPD Sharing Statement :
- ???
- Responsible party:
-
Sponsor
- Study sponsor:
- lead_sponsor
Novartis Pharmaceuticals
Industry
- Collaborators:
- ???
- Investigators:
- Novartis Pharmaceuticals Novartis Pharmaceuticals
- Protocol Registration and Results System:
- ???
- Verification date:
- 2024-05-01