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

NCT07031700 | Not Yet Recruiting Phase 2

• 1 other identifier: FL-RR-MOS01
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Relapsed/Refractory Follicular Lymphoma

Outcome Measures

Primary Outcomes (1)

• best of complete response rate (CR)

  To assess the best of complete response rate (CR) at the end of treatment of Mosunetuzumab with Tislelizumab

  up to the end of 8/17 cycles of treatment(each cycle 21 days)

Secondary Outcomes (4)

• Overall Response Rate (ORR)

  up to the end of 8/17 cycles of treatment(each cycle 21 days)

• Duration of Response (DoR)

  up to 2 years

• Progression-free survival (PFS)

  Assessed every 3 months during follow-up, up to 2 years

• OS

  Assessed every 3 months during follow-up, up to 2 years

Other Outcomes (1)

• Identification of candidate biomarkers associated with treatment response based on RNA-seq and/or whole exome sequencing (WES) data

  up to 2 years

Study Arms (1)

combination therapy of Mosunetuzumab and Tislelizumab

EXPERIMENTAL

Drug: Mosunetuzumab; Drug: Tislelizumab

Interventions

Mosunetuzumab 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.

combination therapy of Mosunetuzumab and Tislelizumab

Tislelizumab DRUG

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

combination therapy of Mosunetuzumab and Tislelizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to comply with study hospitalization and restrictions.
• Active infections (including tuberculosis) or immunocompromised status.
• Prior history of severe hypersensitivity to similar agents.
• CNS involvement of lymphoma.
• Pregnant or breastfeeding women.
• Uncontrolled comorbid conditions, including cardiovascular or autoimmune diseases.
• Receipt of live attenuated vaccines within 4 weeks before enrollment.
• Use of systemic immunosuppressants within 2 weeks prior to first dose.
• History of drug or alcohol abuse in the past 12 months.
• Any condition deemed inappropriate for study participation by the investigator.

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

tislelizumab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Huilai Zhang

CONTACT

+86-18622221228; huilaizhangtz@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of lymphoma department

Study Record Dates

• First Submitted: March 11, 2025
• First Posted: June 22, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): July 30, 2027
• Last Updated: June 22, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share