NCT07355283Not yet recruitingPhase 3
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
Source: ClinicalTrials.gov · Last updated 27 Jan 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 198 (estimated)
- First submitted
- 12 Jan 2026
- Start date
- 1 Feb 2026
- Primary completion date
- 31 Jul 2028
- Lead sponsor
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Diseases
- Follicular lymphoma
- NCT number
- NCT07355283
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 198
- From 1 Feb 2026 to the primary completion date, 31 Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Autologous HSCT within 100 days prior to first administration, or any prior allogeneic HSCT or solid organ transplantation.
- Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein.
Other illness
- 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.
- Human immunodeficiency virus (HIV) infection.
- Active infection requiring systemic therapy (e.g., fungal, bacterial, viral).
Lab values
- Echocardiography examination indicating left ventricular ejection fraction (LVEF) \< 55%.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Cancer Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.