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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| combination therapy of Mosunetuzumab and Tislelizumab | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mosunetuzumab | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Response Rate (ORR) | 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. | up to the end of 8/17 cycles of treatment(each cycle 21 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Identification of candidate biomarkers associated with treatment response based on RNA-seq and/or whole exome sequencing (WES) data | 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. |
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:
Women of childbearing potential must have a negative serum pregnancy test and agree to use contraception.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Huilai Zhang | Contact | +86-18622221228 | huilaizhangtz@163.com |
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|
| Tislelizumab | Drug | - Cycles 2-8: 200 mg IV every 3 weeks |
|
| Duration of Response (DoR) |
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. |
| up to 2 years |
| Progression-free survival (PFS) | Progression-Free Survival is defined as the time from initiation of study treatment to disease progression or death from any cause, whichever occurs first. | Assessed every 3 months during follow-up, up to 2 years |
| OS | Overall Survival is defined as the time from initiation of study treatment to death from any cause. | Assessed every 3 months during follow-up, up to 2 years |
| up to 2 years |
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
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