PHE885 CAR-T Therapy in Adult Participants With Relapsed and Refractory Multiple Myeloma
- Conditions
- Multiple Myeloma
- Registration Number
- NCT05172596
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 146
Inclusion Criteria:<br><br> 1. =18 years of age at the time of informed consent form (ICF) signature<br><br> 2. Adult patients after failure of three or more lines of therapy including an IMiD<br> (e.g., lenalidomide or pomalidomide), a proteasome inhibitor (e.g., bortezomib,<br> carfilzomib), and an approved anti-CD38 antibody (e.g., daratumumab, isatuximab),<br> and who have documented evidence of disease progression (IMWG criteria) 3, Must have<br> received =2 consecutive cycles of treatment for at least three prior regimens unless<br> deemed refractory to that regimen (i.e., progressive disease as the best response)<br><br> 4. Must be refractory to the last treatment regimen (defined as progressive disease on<br> or within 60 days measured from last dose of last regimen).<br><br> 5. Measurable disease at enrollment as defined by the protocol 6. Eastern Cooperative<br> Oncology Group (ECOG) performance status that is either 0 or 1 at screening 7. Must<br> have a leukapheresis material of non-mobilized cells accepted for manufacturing<br><br>Exclusion Criteria:<br><br>1.Prior administration of a genetically modified cellular product including prior BCMA<br>CAR-T therapy. 2.Participants who have received prior BCMA -directed bi-specific<br>antibodies or anti-BCMA antibody drug conjugate.<br><br> 3. Prior autologous SCT within 3 month or allogenic SCT within 6 months prior to<br> signing informed consent.<br><br>4.Plasma cell (PC) leukemia and other plasmacytoid disorders, other than MM 5.POEMS<br>syndrome 6.Active central nervous system (CNS) involvement by malignancy 7.Patients with<br>active neurological autoimmune or inflammatory disorders 8.Inadequate cardiac, renal,<br>hepatic or hematologic function as defined in the protocol.<br><br>Other protocol-defined Inclusion/Exclusion may apply.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall response rate (ORR) per Independent Review Committee (IRC) in Efficacy Analysis Set
- Secondary Outcome Measures
Name Time Method Key Secondary End point: MRD Negativity rate in Bone Marrow;Complete response rate (CRR);Time to response;Duration of Response (DOR);Progression free survival (PFS);Time to next anti-myeloma treatment (TTNT);Overall Survival (OS);Durability of Minimal Residual Disease (MRD)negativity;Patient Reported Outcomes (PRO): EQ-5D-5L Health Questionnaire;Patient Reported Outcomes (PRO): EORTC-QLQ-C30;Patient Reported Outcomes (PRO): EORTC-QLQ-MY20;PHE885 manufacturing success rate;Manufacturing turnaround time;Transgene of PHE885 concentrations over time in peripheral blood and bone marrow;Cellular kinetics parameter: Cmax;Cellular kinetics parameter: Tmax;Cellular kinetics parameter: AUC;Immunogenicity to PHE885