NCT07031700Not yet recruitingPhase 2
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)
Source: ClinicalTrials.gov · Last updated 22 Jun 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (estimated)
- First submitted
- 11 Mar 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Tianjin Medical University Cancer Institute and Hospital
- Diseases
- Follicular lymphoma
- NCT number
- NCT07031700
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 22
- From 1 Jul 2025 to the primary completion date, 30 Jun 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior history of severe hypersensitivity to similar agents.
- Receipt of live attenuated vaccines within 4 weeks before enrollment.
- Use of systemic immunosuppressants within 2 weeks prior to first dose.
Other illness
- Active infections (including tuberculosis) or immunocompromised status.
- Uncontrolled comorbid conditions, including cardiovascular or autoimmune diseases.
- History of drug or alcohol abuse in the past 12 months.
- Any condition deemed inappropriate for study participation by the investigator.
Other
- Inability to comply with study hospitalization and restrictions.
- CNS involvement of lymphoma.
- Pregnant or breastfeeding women.
Who the study is looking for
- Signed written informed consent.
- Age ≥18 years.
- Histologically confirmed relapsed/refractory follicular lymphoma (r/r FL).
- Received at least two prior systemic therapies, including anti-CD20 monoclonal antibody therapy.
- ECOG performance status 0-1.
- Expected survival ≥12 weeks.
- Measurable disease (longest diameter \>1.5 cm).
- 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).
- Women of childbearing potential must have a negative serum pregnancy test and agree to use contraception.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.