Clinical trial · Interventional
A Clinical Study of 6MW3211 Injection in the Treatment of Relapsed/Refractory Lymphoma
A Phase 2, Multicenter, Non-Randomized, Open-Label, Single-Arm Study to Evaluate the Preliminary Efficacy and Safety of 6MW3211 in Patients With Relapsed or Refractory Lymphoma
NCT05446688CI-TRIAL-00059541unknownPhase 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 study is a single arm, non-randomized, open label phase 2 international, multicenter clinical trial to evaluate preliminary efficacy and safety in subjects with relapsed or refractory lymphoma.
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 |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 6MW3211 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 6MW3211
- description
- 6MW3211 injection, 45mg/kg, Q2W
- interventionNames
- Drug: 6MW3211
Primary outcomes (1)
- measure
- Objective response rate
- timeFrame
- 1 Year
- description
- Defined as the percentage of subjects who experience a best response of either CR or PR
Secondary outcomes (7)
- measure
- Complete response rate
- timeFrame
- 1 Year
- description
- Defined as the percentage of subjects who experience a best response of CR
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Voluntarily participate in the study and sign the informed consent. * Age≥18 years. * Subjects with relapsed or refractory lymphoma. * Subjects with at least one measurable tumor lesion. * ECOG 0-2. * Life expectancy≥3 months. * Adequate organ functions. Exclusion Criteria: * Subjects who had received anticancer therapy or radiotherapy within 21 days or 5 half-lives (whichever is shorter) before enrollment or received adoptive cellular immunotherapy within 12 weeks. * Subjects who had received allogeneic hematopoietic stem cell transplantation or organ transplantation or received autologous hematopoietic stem cell transplantation within 3 months. * Subjects with primary or secondary CNS lymphoma. * History of another malignancy within 3 years before the first dose of investigational drug. * History of active autoimmune diseases. * Systemic immunosuppressive therapy within 2 weeks prior to the first dose of investigational drug. * Subjects who experienced grade 3 or above immune-related adverse events (irAE) . * Documented history of uncontrolled systemic diseases. * Subjects who were allergic to any composition of investigational drug. * Major surgery within 28 days prior to first dose of investigational drug. * Subjects with active infection. * Preexisting treatment related toxicity Grade ≥ 2 (except alopecia). * Subjects with poor treatment compliance. * Use of any investigational drug or device within 28 days prior to the first dose of investigational drug. * Live vaccine was administered within 28 days prior to first dose of investigational drug. * Pregnant or lactating women.
References
Publications (0)
Data not yet available
No reference posted for this study.