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

NCT07355283 | Not Yet Recruiting Phase 3

• 1 other identifier: IMM0306-004
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Relapsed/Refractory Follicular Lymphoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Secondary Outcomes (7)

• Complete remission rate(CRR) as Assessed by Independent Review Committee(IRC)

  approximately 48 months

• Progression-Free Survival (PFS) as Assessed by Independent Review Committee(IRC)

  approximately 48 months

• Objective Response Rate (ORR)

  approximately 48 months

• Duration of Response (DOR)

  approximately 48 months

• Overall Survival (OS)

  approximately 60 months

Study Arms (2)

IMM0306 in combination with lenalidomide

EXPERIMENTAL

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: IMM0306 2.0 mg/kg; Drug: Lenalidomide 20 mg

Placebo in combination with lenalidomide

PLACEBO COMPARATOR

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: Placebo; Drug: Lenalidomide 20 mg

Interventions

IMM0306 2.0 mg/kg DRUG

IV infusion;

Also known as: Amulirafusp Alfa

IMM0306 in combination with lenalidomide

Placebo DRUG

IV infusion;

Placebo in combination with lenalidomide

Lenalidomide 20 mg DRUG

orally

IMM0306 in combination with lenalidomide; Placebo in combination with lenalidomide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• ImmuneOnco Biopharmaceuticals (Shanghai) Inc.: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

Location

MeSH Terms

Conditions

Lymphoma, Follicular

Interventions

Lenalidomide

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Yuqin Song, Professor

CONTACT

010-88196118; SongYQ_VIP@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2026
• First Posted: January 21, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): October 1, 2030
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)