Clinical trial · Interventional
A Safety Study of SGN-CD48A in Patients With Multiple Myeloma
A Phase 1 Study of SGN-CD48A in Patients With Relapsed or Refractory Multiple Myeloma
NCT03379584CI-TRIAL-00040691terminatedPhase 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): Due to overall benefit/risk profile
Summary
Brief summary (as posted)
This study will test the safety and activity of SGN-CD48A in patients with multiple myeloma. SGN-CD48A will be given on Days 1, 8, and 15 of a 28-day cycle. Prior to protocol amendment 2, SGN-CD48A was given every 3 weeks.
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 |
|---|---|---|---|
| SGN-CD48A | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SGN-CD48A
- description
- SGN-CD48A
- interventionNames
- Drug: SGN-CD48A
Primary outcomes (3)
- measure
- Type, incidence, severity, seriousness, and relatedness of adverse events
- timeFrame
- Through 1 month following last dose
- measure
- Incidence of laboratory abnormalities
- timeFrame
- Through 1 month following last dose
- measure
- Incidence of dose limiting toxicity
- timeFrame
- Through 3 weeks following first dose
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of MM requiring systemic therapy (per the International Myeloma Working Group \[IMWG\]) * Patients must not have other therapeutic options known to provide clinical benefit in MM available to them. Prior lines of therapy must include at least a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. * Measureable disease, as defined by at least one of the following: serum M protein 0.5 g/dL or higher, urine M protein 200 mg/24 hour or higher, and serum immunoglobulin free light chain 10 mg/dL or higher and abnormal serum immunoglobulin kappa lambda free light chain ratio * Adequate hematologic, renal, and hepatic function * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Life expectancy greater than 3 months * A negative pregnancy test (for females of childbearing potential) * Patients must provide written consent Exclusion Criteria: * Pre-existing peripheral neuropathy Grade 2 or higher * History of malignancy other than MM within the past 3 years * Active cerebral/meningeal disease related to the underlying malignancy * Uncontrolled Grade 3 or higher infection * Known to be positive for HIV or hepatitis B, or known to have active hepatitis C infection * Previous allogeneic stem cell transplant * History of cerebral vascular event, unstable angina, myocardial infarction, or cardiac symptoms consistent with congestive heart failure within the last 6 months * Treatment with any known P-gp inducers/inhibitors or strong CYP3A inhibitors within 14 days prior to the first dose of study drug * Prior antitumor therapy that is not completed at least 4 weeks prior to first dose of study drug, or at least 2 weeks if progressing. Prior CAR T-cell therapy must be completed 8 weeks before first dose of study drug. * Females who are pregnant or breastfeeding
References
Publications (0)
Data not yet available
No reference posted for this study.