This study is a randomized, controlled, double-blind, multicenter, phase III clinical study to evaluate the efficacy of IMM0306 (Amulirafusp Alfa)in combination with lenalidomide versus placebo in combination with lenalidomide in patients with Relapsed/Refractory Follicular lymphoma. Primary endpoints are Complete Remission Rate (CRR) and Progression-Free Survival (PFS).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
2. At least one measurable lesion (as per Lugano 2014 criteria).
3. Histologically confirmed CD20-positive Follicular Lymphoma, Grade 1, 2, or 3a.
4. Previously received at least two prior systemic regimens, including at least one line containing an anti-CD20 monoclonal antibody.
5. Adequate hepatic, hematologic, and renal function.
6. Expected survival at least 6 months.
Exclusion Criteria:
1. Autologous HSCT within 100 days prior to first administration, or any prior allogeneic HSCT or solid organ transplantation.
2. History of central nervous system (CNS) metastases or active CNS involvement.
3. History of other malignancy within the past 5 years.
4. Severe organic cardiovascular or cerebrovascular diseases.
5. History of severe allergic reactions to any components of the trial drug, any macromolecular protein preparations or monoclonal antibodies.
6. Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein.
7. Human immunodeficiency virus (HIV) infection.
8. Echocardiography examination indicating left ventricular ejection fraction (LVEF) \< 55%.
9. Active infection requiring systemic therapy (e.g., fungal, bacterial, viral).
Primary outcome measure(s)
Complete remission rate(CRR) as Assessed by Investigator — approximately 48 months CRR is defined as the percentage of participants who achieve a CR(Complete Response) determined per Lugano 2014 criteria (2014 Lugano Revised Response Criteria for Malignant Lymphoma).
Progression-Free Survival (PFS) as Assessed by Investigator — approximately 48 months PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.
Trial sites (1)
Facility
City
Region
Status
Beijing Cancer Hospital
Beijing
China
More ImmuneOnco Biopharmaceuticals (Shanghai) Inc. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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