Clinical trial · Interventional
Study of ACTR087 in Combination With SEA-BCMA in Subjects With Relapsed or Refractory Multiple Myeloma
A Phase 1 Study of ACTR087, an Autologous T Cell Product, in Combination With SEA-BCMA, a Monoclonal Antibody, in Subjects With Relapsed or Refractory Multiple Myeloma
NCT03266692CI-TRIAL-00044317terminatedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Business reasons
Summary
Brief summary (as posted)
This is a phase 1, multi-center, single-arm, open-label study evaluating the safety, tolerability, and anti-myeloma activity of ACTR087 (an autologous T cell product) in combination with SEA-BCMA (a monoclonal antibody) in subjects with relapsed or refractory Multiple Myeloma.
Conditions
Conditions (3)
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 |
| Multiple Myeloma in Relapse | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ACTR087 | Biological | — | UNRESOLVED |
| SEA-BCMA | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ACTR087 in combination with SEA-BCMA
- interventionNames
- Biological: ACTR087
- Biological: SEA-BCMA
Primary outcomes (2)
- measure
- Safety and tolerability of ACTR087 in combination with SEA-BCMA
- timeFrame
- 28 days
- description
- Composite outcome measure assessed by committee review of dose limiting toxicities (DLTs), incidence and severity of AEs and clinically significant abnormalities of laboratory values
- measure
- Determination of recommended Phase 2 dosing regimen
- timeFrame
- 52 weeks
- description
- Review of DLTs, Maximum tolerated contour (MTC), incidence and severity of AEs and clinically significant abnormalities of laboratory values
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Signed written informed consent obtained prior to study procedures * Histologically- or cytologically-confirmed relapsed or refractory multiple myeloma (MM) with measurable disease * Must have received at least 3 prior lines of therapy to include treatment with a proteasome inhibitor (eg, bortezomib, carfilzomib, or ixazomib) and an immunomodulatory agent (eg, lenalidomide, pomalidomide) unless double-refractory to both; and a hematopoietic stem cell transplant (HSCT), for those subjects considered HSCT-eligible. * Quantitative serum IgG levels for subjects with IgG MM must not exceed the institutional upper limit of normal (ULN) * ECOG 0 or 1 * Life expectancy of at least 6 months * Absolute neutrophil (ANC) count greater than 1000/ µL * Platelet count greater than 50,000/µL * Estimated GFR \>30mL/min/1.73m2 Exclusion Criteria: * Known active central nervous system (CNS) involvement by MM * Systemic rheumatic or autoimmune diseases or acute or chronic infections * Uncontrolled thromboembolic events or recent severe hemorrhage * Subjects who are currently using more than 5mg/day of prednisone (or an equivalent glucocorticoid exceeding physiologic replacement levels) * Prior treatment as follows: * T cell-directed antibody therapy (eg. Alemtuzumab, anti-thymocyte globulin) within 6 months of enrollment * Any prior myeloma-directed therapy including cytotoxic chemotherapy, biologic therapy, or radiotherapy within 2 weeks of enrollment * Any mAb or other protein therapeutic containing Fc-domains within 4 weeks of enrollment * Experimental agents within 3 half-lives prior to enrollment, unless progression is documented on therapy * Prior BCMA-directed investigational agents at any time * Prior cell or gene therapy, excluding transfers of genetically unmodified autologous cells (eg. Hematopoietic stem cell transplantation), at any time; or prior allogeneic HSCT at any time * Pregnant or breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.