Ireland
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Starting soon Phase 3

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

NCT07355283 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2026-02
Last updated
2026-01-27

Condition(s) studied

Relapsed/Refractory Follicular Lymphoma

Investigational drug(s) / intervention(s)

IMM0306 2.0 mg/kg →PlaceboLenalidomide 20 mg →

IMM0306 2.0 mg/kg: IV infusion;

Placebo: IV infusion;

Lenalidomide 20 mg: orally

Study 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).

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)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing China
Official registry record

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.

View NCT07355283 on ClinicalTrials.gov ↗ ← All trials in China