Clinical trial · Interventional
A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for r/r FL
A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for Relapsed/Refractory Follicular Lymphoma (r/r FL)
NCT07031700CI-TRIAL-00091245not yet recruitingPhase 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 is a multicenter, single-arm, open-label, investigator-initiated, phase II clinical trial designed to evaluate the feasibility, efficacy, and safety of Mosunetuzumab in combination with Tislelizumab in patients with relapsed/refractory follicular lymphoma (r/r FL).
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/Refractory Follicular Lymphoma | Follicular Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Mosunetuzumab | Drug | Mosunetuzumab | ALIAS |
| Tislelizumab | Drug | Tislelizumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- combination therapy of Mosunetuzumab and Tislelizumab
- interventionNames
- Drug: Mosunetuzumab
- Drug: Tislelizumab
Primary outcomes (1)
- measure
- best of complete response rate (CR)
- timeFrame
- up to the end of 8/17 cycles of treatment(each cycle 21 days)
- description
- To assess the best of complete response rate (CR) at the end of treatment of Mosunetuzumab with Tislelizumab
Secondary outcomes (4)
- measure
- Overall Response Rate (ORR)
- timeFrame
- up to the end of 8/17 cycles of treatment(each cycle 21 days)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed written informed consent. 2. Age ≥18 years. 3. Histologically confirmed relapsed/refractory follicular lymphoma (r/r FL). 4. Received at least two prior systemic therapies, including anti-CD20 monoclonal antibody therapy. 5. ECOG performance status 0-1. 6. Expected survival ≥12 weeks. 7. Measurable disease (longest diameter \>1.5 cm). 8. Adequate organ function: * Hepatic function: Total bilirubin ≤1.5×ULN; AST/ALT ≤3×ULN. * Hematologic function: ANC ≥1.5 × 10⁹/L; Platelets ≥75,000/μL; Hemoglobin ≥10.0 g/dL. * Renal function: Serum creatinine ≤1.5×ULN or CrCl ≥50 mL/min (Cockcroft-Gault formula). 9. Women of childbearing potential must have a negative serum pregnancy test and agree to use contraception. Exclusion Criteria: 1. Inability to comply with study hospitalization and restrictions. 2. Active infections (including tuberculosis) or immunocompromised status. 3. Prior history of severe hypersensitivity to similar agents. 4. CNS involvement of lymphoma. 5. Pregnant or breastfeeding women. 6. Uncontrolled comorbid conditions, including cardiovascular or autoimmune diseases. 7. Receipt of live attenuated vaccines within 4 weeks before enrollment. 8. Use of systemic immunosuppressants within 2 weeks prior to first dose. 9. History of drug or alcohol abuse in the past 12 months. 10. Any condition deemed inappropriate for study participation by the investigator.
References
Publications (0)
Data not yet available
No reference posted for this study.