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NCT Number: NCT07355283

IMM0306 in Combination With Lenalidomide vs 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).

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Key information

Conditions

Relapsed/Refractory Follicular Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing Cancer Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

IMM0306 2.0 mg/kg

Drug

IV infusion;

Other names: Amulirafusp Alfa

Placebo

Drug

IV infusion;

Lenalidomide 20 mg

Drug

orally

Primary outcomes

  1. Complete remission rate(CRR) as Assessed by Investigator

    Time frame: 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).

  2. Progression-Free Survival (PFS) as Assessed by Investigator

    Time frame: 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.

Secondary outcomes

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

    Time frame: approximately 48 months

    CRR is defined as the percentage of participants who achieve a CR determined per Lugano 2014 criteria.

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

    Time frame: 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.

  3. Objective Response Rate (ORR)

    Time frame: approximately 48 months

    ORR is defined as the proportion of the analysis population achieving CR, PR(Partial Response).

  4. Duration of Response (DOR)

    Time frame: approximately 48 months

    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.

  5. Overall Survival (OS)

    Time frame: approximately 60 months

    OS is defined as the time from randomization to death due to any cause.

  6. Time to Next Anti-Lymphoma Treatment(TTNT)

    Time frame: approximately 48 months

    TTNT is defined as the number of days from randomization to the date of next anti-lymphoma treatment.

  7. Adverse Event (AE)

    Time frame: approximately 48 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuqin Song, Professor

CONTACT

[email protected]

010-88196118

Sponsors and collaborators

Lead sponsor

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jan 21, 2026
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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