A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for r/r FL

Phase 2

Not yet recruiting

• Conditions: Relapsed/Refractory Follicular Lymphoma
• Interventions: Drug: Mosunetuzumab; Drug: Tislelizumab

• Registration Number: NCT07031700
• Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Brief Summary

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).

Detailed Description

The study aims to enroll approximately 22 adult patients who have received at least two prior systemic therapies, including anti-CD20 monoclonal antibody treatment. The primary endpoint is the complete response rate (CR), while secondary endpoints include objective response rate (ORR), duration of response (DOR), progression-free survival (PFS), overall survival (OS), and safety assessment. The trial will be conducted at multiple centers in China, with an estimated study duration from May 2025 to May 2027.

Study Timeline

• Study First Submitted: 2025-03-11
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-12
• Last Update Submitted: 2025-06-12
• Study First Posted: 2025-06-22
• Last Update Posted: 2025-06-22
• Study Start: 2025-07-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-07-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 22

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
combination therapy of Mosunetuzumab and Tislelizumab	Mosunetuzumab	-
combination therapy of Mosunetuzumab and Tislelizumab	Tislelizumab	-

Primary Outcome Measures

Name	Time	Method
best of complete response rate (CR)	up to the end of 8/17 cycles of treatment(each cycle 21 days)	To assess the best of complete response rate (CR) at the end of treatment of Mosunetuzumab with Tislelizumab

Secondary Outcome Measures

Name	Time	Method
OS	Assessed every 3 months during follow-up, up to 2 years	Overall Survival is defined as the time from initiation of study treatment to death from any cause.
Overall Response Rate (ORR)	up to the end of 8/17 cycles of treatment(each cycle 21 days)	Objective Response Rate is defined as the proportion of subjects who achieve complete response (CR) or partial response (PR) after treatment with Mosunetuzumab and Tislelizumab, as assessed according to Lugano 2014 criteria.
Duration of Response (DoR)	up to 2 years	Duration of Response is defined as the time from the first documentation of objective response (CR or PR) to the first documentation of disease progression or death from any cause, whichever occurs first. Response will be assessed per Lugano 2014 criteria.
Progression-free survival (PFS)	Assessed every 3 months during follow-up, up to 2 years	Progression-Free Survival is defined as the time from initiation of study treatment to disease progression or death from any cause, whichever occurs first.