Relapsed/Refractory Follicular Lymphoma
Conditions
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.
Interventions
DRUGMosunetuzumab
* 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.
DRUGTislelizumab
\- Cycles 2-8: 200 mg IV every 3 weeks
Sponsors
Tianjin Medical University Cancer Institute and Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Identification of candidate biomarkers associated with treatment response based on RNA-seq and/or whole exome sequencing (WES) data | 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. |
Contacts
Primary ContactHuilai Zhang
Outcome results
None listed