Clinical trial · Interventional
P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)
Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P BCMA-101 in Subjects With Relapsed / Refractory Multiple Myeloma (MM) Followed by a Phase 2 Assessment of Response and Safety (PRIME)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Phase I portion of the study was completed. The phase II portion of the study was terminated early to focus on an Allogeneic BCMA CAR-T program.
Summary
Brief summary (as posted)
Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple cohort study; a multiple dose cycle administration cohort study; and a combination administration study of P-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in patients with relapsed / refractory MM. Followed by a Phase 2, open-label, efficacy and safety study. Rimiducid may be administered as indicated.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| P-BCMA-101 CAR-T cells | Biological | — | UNRESOLVED |
| Rimiducid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (8)
- type
- EXPERIMENTAL
- label
- Phase 1: P-BCMA-101 CAR-T cells
- description
- Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.
- interventionNames
- Biological: P-BCMA-101 CAR-T cells
- Drug: Rimiducid
- type
- EXPERIMENTAL
- label
- Phase 1 P-BCMA-101 CAR-T cells (Cohort A)
- description
- Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.
- interventionNames
- Biological: P-BCMA-101 CAR-T cells
- Drug: Rimiducid
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males or females, ≥18 years of age * Must have a confirmed diagnosis of active MM * Must have measurable MM * Must have relapsed / refractory MM, having received treatment with proteasome inhibitor and IMiD \[Phase 2: Must have relapsed / refractory MM, and refractory to last line of therapy, having received treatment with proteasome inhibitor, an IMiD, CD38 targeted therapy and undergone autologous stem cell transplant (ASCT) or not a candidate for ASCT.\] * Must have adequate hepatic, renal, cardiac and hematopoietic function Exclusion Criteria: * Is pregnant or lactating * Has inadequate venous access and/or contraindications to leukapheresis * Has active hemolytic anemia, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, disseminated intravascular coagulation, leukostasis, amyloidosis, significant autoimmune, CNS or other malignant disease * Has an active second malignancy (not disease-free for at least 5 years) in addition to MM, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma. * Has active autoimmune disease * Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy, etc. * Has an active systemic infection * Has hepatitis B or C virus, human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection, or any immunodeficiency syndrome. * Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol * Has receiving immunosuppressive or other contraindicated therapies within the excluded time frame from entry * Has CNS metastases or symptomatic CNS involvement * Has a history of having undergone allogeneic stem cell transplantation, or any other allogeneic or xenogeneic transplant, or has undergone autologous transplantation within 90 days. * Unable to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation. (Cohorts R and RP only). * History of thromboembolic disease within the past 6 months, regardless of anticoagulation (Cohorts R and RP only).
References
Publications (1)
- DERIVEDMiah KM, Hyde SC, Gill DR. Emerging gene therapies for cystic fibrosis. Expert Rev Respir Med. 2019 Aug;13(8):709-725. doi: 10.1080/17476348.2019.1634547. Epub 2019 Jun 27. PMID 31215818