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NCT Number: NCT07031700

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

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).

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Key information

Conditions

Relapsed/Refractory Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Tislelizumab

Drug
  • Cycles 2-8: 200 mg IV every 3 weeks

Primary outcomes

  1. best of complete response rate (CR)

    Time frame: 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 outcomes

  1. Overall Response Rate (ORR)

    Time frame: 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.

  2. Duration of Response (DoR)

    Time frame: 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.

  3. Progression-free survival (PFS)

    Time frame: 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.

  4. OS

    Time frame: 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.

Other outcomes

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

    Time frame: up to 2 years

    Tumor and/or blood samples will be collected at baseline and during treatment. RNA sequencing (RNA-seq) and/or whole exome sequencing (WES) will be performed to identify gene expression signatures, somatic mutations, or pathway alterations that correlate with clinical response (e.g., CR/PR vs. SD/PD) to the combination therapy of Mosunetuzumab and Tislelizumab.

Study contacts

Contact information is provided by the study sponsor or research team.

Huilai Zhang

CONTACT

[email protected]

+86-18622221228

Sponsors and collaborators

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital

Other

Registry information

Official study title

A Multicenter, Single-Arm, Open-Label, Phase II Trial of Mosunetuzumab in Combination With Tislelizumab for Relapsed/Refractory Follicular Lymphoma (r/r FL)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 22, 2025
Registry last updated
Jun 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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