IMM0306 in Combination With Lenalidomide vs Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IMM0306 2.0 mg/kg, Placebo, Lenalidomide 20 mg.
- Who it may be relevant to
- Registry conditions: Relapsed/Refractory Follicular Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Randomized, Double-Blind, Controlled, Multicenter, Phase III Clinical Study of IMM0306 (Amulirafusp Alfa) for Injection in Combination With Lenalidomide Versus Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma
Overview
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).
Interventions
- Drug IMM0306 2.0 mg/kg
IV infusion; - Drug Placebo
IV infusion; - Drug Lenalidomide 20 mg
orally
Primary outcome measures
- Complete remission rate(CRR) as Assessed by Investigator [Time frame: approximately 48 months]
- Progression-Free Survival (PFS) as Assessed by Investigator [Time frame: approximately 48 months]
Secondary outcome measures (7)
- Complete remission rate(CRR) as Assessed by Independent Review Committee(IRC) [Time frame: approximately 48 months]
- Progression-Free Survival (PFS) as Assessed by Independent Review Committee(IRC) [Time frame: approximately 48 months]
- Objective Response Rate (ORR) [Time frame: approximately 48 months]
- Duration of Response (DOR) [Time frame: approximately 48 months]
- Overall Survival (OS) [Time frame: approximately 60 months]
- Time to Next Anti-Lymphoma Treatment(TTNT) [Time frame: approximately 48 months]
- Adverse Event (AE) [Time frame: approximately 48 months]
Eligibility criteria
Inclusion criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- At least one measurable lesion (as per Lugano 2014 criteria).
- Histologically confirmed CD20-positive Follicular Lymphoma, Grade 1, 2, or 3a.
- Previously received at least two prior systemic regimens, including at least one line containing an anti-CD20 monoclonal antibody.
- Adequate hepatic, hematologic, and renal function.
- Expected survival at least 6 months.
Exclusion criteria
- Autologous HSCT within 100 days prior to first administration, or any prior allogeneic HSCT or solid organ transplantation.
- History of central nervous system (CNS) metastases or active CNS involvement.
- History of other malignancy within the past 5 years.
- Severe organic cardiovascular or cerebrovascular diseases.
- History of severe allergic reactions to any components of the trial drug, any macromolecular protein preparations or monoclonal antibodies.
- Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein.
- Human immunodeficiency virus (HIV) infection.
- Echocardiography examination indicating left ventricular ejection fraction (LVEF) < 55%.
- Active infection requiring systemic therapy (e.g., fungal, bacterial, viral).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Beijing Cancer Hospital — Beijing
Identifiers
NCT: NCT07355283 · IMM0306-004