Clinical trial · Interventional
TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma
A Phase 2, Multi-center, Single-arm Study of TJ202 Combined With Dexamethasone in Subjects With Relapsed or Refractory Multiple Myeloma Who Received at Least 2 Prior Lines of Treatment
NCT03860038CI-TRIAL-00088899completedPhase 2ClinicalTrials.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 trial is a multi-center, single-arm phase 2 study to evaluate the efficacy and safety of TJ202 combined with dexamethasone in subjects with relapsed or refractory multiple myeloma (RRMM) who received at least 2 prior lines of treatment.
Conditions
Conditions (2)
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 in Relapse | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Refractory Multiple Myeloma | Multiple Myeloma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| TJ202 and Dexamethasone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- TJ202
- interventionNames
- Drug: TJ202 and Dexamethasone
Primary outcomes (1)
- measure
- Overall response rate (ORR)
- timeFrame
- end of study [ Time Frame: Approximately up to 2 years ]
- description
- defined as the proportion of subjects achieving stringent complete response (sCR), complete response (CR), very good partial response (VGPR) and partial response (PR)
Secondary outcomes (6)
- measure
- Clinical benefit rate (CBR)
- timeFrame
- end of study [ Time Frame: Approximately up to 2 years ]
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: 1. Age ≥ 18, male or female; 2. Subject must have had documented MM; 3. At screening phase, subject must have measurable disease; 4. Subject is in a state of progressive disease (PD); 5. Subject must have life expectancy of no less than 6 months; 6. Subject must have an ECOG (Eastern Cooperative Oncology Group) performance status score of 0\~2; Exclusion criteria: 1. Subject has received anti-CD38 monoclonal antibody treatment previously; 2. Subject has received CAR-T cell therapy previously; 3. Subject has previously received allogenic stem cell transplant, or subject has received autologous stem cell transplant within 3 months before administration of the study agent; 4. Primary refractory multiple myeloma (subject failed to generate any minimal response or any degree of response to any therapy); 5. Subject has received anti-myeloma treatment (radiotherapy is excluded) within 4 weeks or 5 PK half-lives of the treatment, whichever longer, before the first study agent administration.
References
Publications (0)
Data not yet available
No reference posted for this study.