Clinical trial · Interventional
Study to Assess Allogeneic Anti-CD38 A2 Dimeric Antigen Receptor T Cells in Relapsed or Refractory Multiple Myeloma
A Phase 1b, Open-Label Study of the Safety and Efficacy of Allogeneic Anti-CD38 A2 Dimeric Antigen Receptor (DAR)-T Cells in Patients With Relapsed or Refractory Multiple Myeloma
NCT05007418CI-TRIAL-00063245unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a phase 1b, open-label, dose-escalation study of STI-1492 administered by a single intravenous infusion in subjects with relapsed or refractory multiple myeloma.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| STI-1492 | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- STI-1492
- description
- Four dosing cohorts will be evaluated: Cohort 1 (1 × 10\^5 donor DAR-T cells/kg); Cohort 2 (5 × 10\^5 donor DAR-T cells/kg); Cohort 3 (1 × 10\^6 donor DAR-T cells/kg); Cohort 4 (3 × 10\^6 donor DAR-T cells/kg) where STI-1492 will be administered intravenously once.
- interventionNames
- Biological: STI-1492
Primary outcomes (1)
- measure
- Safety of STI-1492
- timeFrame
- Baseline through study completion at up to approximately 54 months
- description
- Safety as assessed by incidence of adverse events, SAEs, DLTs, neurotoxicity, cytokine release syndrome, host rejection, and laboratory abnormalities
Secondary outcomes (3)
- measure
- Overall response and duration
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must have relapsed or refractory multiple myeloma (RRMM) after having received prior lines of anti-myeloma treatments. * Measurable disease as defined by one of the following: abnormal serum or M-protein levels; abnormal serum free light chain (FLC) assay; ≥ 30% clonal plasma cells in the bone marrow aspirate or biopsy sample * Evidence of cell membrane CD38 expression as determined by immunohistochemistry (IHC) analysis ofbone marrow biopsy or extramedullary plasmacytoma * Pulse oximetry ≥ 92% on room air * Have a life expectancy ≥ 12 weeks * Be willing and able to comply with the study schedule and all study requirements * Willing to follow contraception guidelines Exclusion Criteria: * Previous treatment with any systemic therapy for multiple myeloma within 14 days prior to start of study dose * Treatment with any cellular therapy within 8 weeks prior to start of study dose * Have any unresolved toxicity ≥ Grade 2 from previous anticancer therapies * A history of brain metastasis or spinal cord compression * Has an ECOG performance status (PS) ≥ 3 * Has received allogeneic hematopoietic stem cell transplantation (HSCT) within 6 months, has active graft-versus-host disease (GvHD) following transplant, or is currently receiving immunosuppressive therapy following transplant * Has any clinically significant low baseline lab results for hemoglobin, platelet counts, and neutrophil counts at screening unless resulting from underlying RRMM * Has any clinically significant elevated baseline lab results for serum creatinine, AST or β2 microglobulin * Abnormal INR or aPTT, unless on a stable dose of an anticoagulant * Has known HIV or acquired immunodeficiency syndrome-related illness, acute or history of chronic hepatitis B or C * Is currently pregnant or breast feeding or planning on either during the study. * Has an active bacterial, viral, or fungal infection * Has active plasma cell leukemia * Has extramedullary plasmacytoma(s) * Has any significant medical condition, abnormality, or psychiatric illness that would prevent study participation * Has left ventricular ejection fraction (LVEF) \< 40% * Has second primary malignancies (SPMs) in addition to multiple myeloma if the SPM has required therapy within the last 3 years or is not in complete remission * Has any additional clinical history of the CNS or cardiovascular disease that would place the patient at an unacceptable risk if the patient participates in the study
References
Publications (0)
Data not yet available
No reference posted for this study.