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

ImmuneOnco Biopharmaceuticals

Status and phase: Not yet enrolling; Phase 3

Conditions: Relapsed/Refractory Follicular Lymphoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07355283

IMM0306-004

Details and patient eligibility

About

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).

Enrollment: 198 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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198 participants in 2 patient groups, including a placebo group

IMM0306 in combination with lenalidomide

Experimental group

Description:

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.

Treatment:

Drug: IMM0306 2.0 mg/kg

Drug: Lenalidomide 20 mg

Placebo in combination with lenalidomide

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo

Drug: Lenalidomide 20 mg