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

NCT ID: NCT07031700

Last Updated: 2025-06-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-07-30

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.

Conditions

Relapsed/Refractory Follicular Lymphoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

combination therapy of Mosunetuzumab and Tislelizumab

Group Type: EXPERIMENTAL

Mosunetuzumab

Intervention Type: DRUG

• Cycle 1: Day 1: 1 mg; Day 8: 2 mg; Day 15: 30 mg
• Cycles 2-8: 30 mg every 3 weeks
• Cycles 9-17: 30 mg every 3 weeks (if applicable） A treatment cycle is 21 days. Patients achieving complete remission (CR) by cycle 8 will stop treatment, while those with partial response (PR) or stable disease (SD) may continue up to 17 cycles or until disease progression or intolerable toxicity occurs.

Tislelizumab

Intervention Type: DRUG

\- Cycles 2-8: 200 mg IV every 3 weeks

Interventions

Mosunetuzumab

• Cycle 1: Day 1: 1 mg; Day 8: 2 mg; Day 15: 30 mg
• Cycles 2-8: 30 mg every 3 weeks
• Cycles 9-17: 30 mg every 3 weeks (if applicable） A treatment cycle is 21 days. Patients achieving complete remission (CR) by cycle 8 will stop treatment, while those with partial response (PR) or stable disease (SD) may continue up to 17 cycles or until disease progression or intolerable toxicity occurs.

Intervention Type: DRUG

Tislelizumab

\- Cycles 2-8: 200 mg IV every 3 weeks

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tianjin Medical University Cancer Institute and Hospital

OTHER

Sponsor Role: lead

Responsible Party

Huilai Zhang

Director of lymphoma department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Huilai Zhang

Role: CONTACT

huilaizhangtz@163.com

+86-18622221228

Other Identifiers

FL-RR-MOS01

Identifier Type: -

Identifier Source: org_study_id