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

StatusNot Yet Recruiting
PhasePhase 3
Started2026-02
View on ClinicalTrials.gov ↗

Amendment history

2026-01-25
minor
Study Identification, Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v1
InterventionsIMM0306 2.0mg/kg (Drug), Lenalidomide 20 mg (Drug), Placebo (Drug)→IMM0306 2.0 mg/kg (Drug), Lenalidomide 20 mg (Drug), Placebo (Drug)
Eligibility criteria-47 characters
[...] riteria). Histologically confirmed CD20-positive Follicular lymphomaLymphoma, Grade 1, 2, or 3a. Previously received at least two prior systemic regimenregimens, including at least one line containing an anti-CD20 monocl [...] hematologic, and renal function. Expected survival at least≥ 6 months. Exclusion Criteria: Autologous HSCT within 100 da [...] s. Severe organic cardiovascular or cerebrovascular diseases, or active infection requiring systemic therapy. History of severe allergic reactions to any components of [...]
Secondary endpoints7 entries, revised
Complete remission rate(CRR) as Assessed by Independent YReviewReview Committee(IRC)
Study titlerevised
IMM0306 in Combination With Lenalidomide VSvs Placebo in Combination With Lenalidomide in Patients With Relapsed/Refractory Follicular Lymphoma
2026-01-12
minor
Original filing
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).
Trial Details
NCT Number NCT07355283
Lead Sponsor ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Conditions Relapsed/Refractory Follicular Lymphoma
Enrollment 198 participants
Start Date 2026-02
Primary Completion 2028-07 (estimated)
Study Completion 2030-10 (estimated)
Updated on ClinicalTrials.gov 2026-01-27