IMM0306 in Combination With Lenalidomide vs Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma

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

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Relapsed/Refractory Follicular Lymphoma
• Intervention / Treatment: Drug: Lenalidomide 20 mg; Drug: Placebo; Drug: IMM0306 2.0 mg/kg

• Study Type: Interventional
• Enrollment (Estimated): 198
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yuqin Song, Professor; Phone Number: 010-88196118; Email: SongYQ_VIP@163.com

Study Locations

• China
  • Beijing, China
    • Beijing Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo in combination with lenalidomide; One treatment cycle consists of 4 weeks (28 days). Placebo will be administered once weekly, and lenalidomide will be administered from Day 1 to Day 21 of each cycle.	Drug: Lenalidomide 20 mg; orally; Drug: Placebo; IV infusion;
Experimental: IMM0306 in combination with lenalidomide; One treatment cycle consists of 4 weeks (28 days). IMM0306 (Amulirafusp Alfa) will be administered once weekly, and lenalidomide will be administered from Day 1 to Day 21 of each cycle.	Drug: Lenalidomide 20 mg; orally; Drug: IMM0306 2.0 mg/kg; IV infusion; Other Names: Amulirafusp Alfa

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) as Assessed by Investigator	PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.	approximately 48 months
Complete remission rate(CRR) as Assessed by Investigator	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).	approximately 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-Free Survival (PFS) as Assessed by Independent Review Committee(IRC)	PFS is defined as the time from randomization to the first documented disease progression or death due to any cause, whichever occurs first.	approximately 48 months
Duration of Response (DOR)	DOR is defined as the time from the first documented evidence of complete response or partial response until disease progression or death due to any cause, whichever occurs first.	approximately 48 months
Overall Survival (OS)	OS is defined as the time from randomization to death due to any cause.	approximately 60 months
Time to Next Anti-Lymphoma Treatment(TTNT)	TTNT is defined as the number of days from randomization to the date of next anti-lymphoma treatment.	approximately 48 months
Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant temporally associated with the use of study intervention, whether or not considered related to the study intervention.	approximately 48 months
Complete remission rate(CRR) as Assessed by Independent Review Committee(IRC)	CRR is defined as the percentage of participants who achieve a CR determined per Lugano 2014 criteria.	approximately 48 months
Objective Response Rate (ORR)	ORR is defined as the proportion of the analysis population achieving CR, PR(Partial Response).	approximately 48 months

Collaborators and Investigators

• Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): October 1, 2030

Study Registration Dates

• First Submitted: January 12, 2026
• First Submitted That Met QC Criteria: January 12, 2026
• First Posted (Actual): January 21, 2026

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Immune System Diseases; Neoplasms by Histologic Type; Lymphatic Diseases; Lymphoproliferative Disorders; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Hemic and Lymphatic Diseases; Lymphoma, Follicular; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Carboxylic Acids; Piperidines; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Piperidones; Isoindoles; Lenalidomide
• Other Study ID Numbers: IMM0306-004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No