Clinical trial · Interventional
A Study of QLS4131 in Patients With Recurrent or Refractory Multiple Myeloma
Phase I Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Effectiveness of QLS4131 Injection in Patients With Relapsed or Refractory Multiple Myeloma
NCT06500507CI-TRIAL-00078804not yet recruitingPhase 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)
The purpose of this study is to characterize the safety of QLS4131 injection and to determine the recommended Phase 2 dose (RP2D) and to further evaluate the efficacy and safety of QLS4131 injection in participants with relapsed or refractory multiple myeloma at the recommended Phase 2 dose.
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 |
|---|---|---|---|
| Relapsed or Refractory Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| QLS4131 Injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- QLS4131
- description
- Dose escalation and does expansion of QLS4131 injection will be evaluated.
- interventionNames
- Drug: QLS4131 Injection
Primary outcomes (2)
- measure
- Recommended Phase 2 Dose (RP2D)
- timeFrame
- Approximately 2 years
- description
- Determination of the recommended phase 2 dose (RP2D) of QLS41315 injection in patient with relapsed or refractory multiple myeloma
- measure
- Incidence of adverse events（AEs）
- timeFrame
- Up to 2 years
- description
- Assessing the incidence of adverse events (AEs) using the Common Terminology Criteria for Adverse Events (CTCAE Version 5).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years old, regardless of gender. 2. Subjects should be willing and able to comply with the study schedule and protocols. 3. Documented initial diagnosis of multiple myeloma according to International Myeloma Working Group (IMWG) diagnostic criteria. 4. Must have measurable disease as defined by the following: Serum M-protein greater than or equal to 1 g/dL; OR Urine M-protein greater than or equal to 200 mg/24 hours; OR Serum free light chain (FLC) assay; involved FLC level greater than or equal to 10 mg/dL provided the serum FLC ratio is abnormal. Exclusion Criteria: 1. Known hypersensitivity to any of the ingredients of this product. 2. Known active central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma. 3. Has any active severe mental illness, medical illness, or other symptoms/conditions that may affect treatment, compliance, or the ability to provide informed consent, as determined by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.