Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma

Phase 1

Recruiting

• Conditions: CD20-positive B-cell Non-Hodgkin's Lymphoma
• Interventions: Drug: IMM0306

• Registration Number: NCT05805943
• Lead Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Brief Summary

This is a Phase I/II, Single-Arm, Open-Label, Multicentre Study to Evaluate the Safety and Efficacy of IMM0306 in Patients with Relapsed or Refractory B-Cell Non- Hodgkin's Lymphoma (R/R B-NHL).

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-02
• Status Verified: 2023-03
• Study First Submitted: 2023-03-24
• Study First Submitted QC: 2023-04-06
• Last Update Submitted: 2023-04-06
• Study First Posted: 2023-04-10
• Last Update Posted: 2023-04-10
• Primary Completion: 2025-05-25
• Study Completion: 2025-05-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 154

Inclusion Criteria

• Relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) that has been diagnosed, including but not limited to diffuse large B-cell lymphoma (DLBCL) Follicular lymphoma (FL), mucosal lymphoma (MALT-L), small lymphocytic lymphoma (SLL) / chronic lymphocytic leukemia (CLL).
• At least one measurable or assessable tumor lesion.
• Adequate organ and hematologic function.
• Eastern Co-operative Oncology Group (ECOG) score 0 to 2.
• All adverse events from prior treatment must be CTCAE v5.0 grade <= 1

Exclusion Criteria

• Active central nervous system (CNS) lymphoma.
• Systemic steroid therapy (dose equivalent to > 10 mg prednisone / day).
• History of severe allergic reactions to macromolecular protein preparations/monoclonal antibodies and any test drug components (CTCAE v5.0 grade >=3).
• Have evidence of severe uncontrollable active infection.
• Subjects have deep vein embolism or pulmonary embolism within 6 months before screening.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IMM0306 Monotherapy	IMM0306	Phase I dose escalation part, participants with relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) will be enrolled to receive IMM0306. The dose of IMM0306 will depend on when you join this study. About 1-6 participants will be enrolled at each dose level. Phase II dose expansion part, participants will receive IMM0306 at the recommended dose that was found in dose escalation part.

Primary Outcome Measures

Name	Time	Method
Dose-limiting toxicity	Evaluated for DLTs during the first 28-day cycle
Complete response rate	up to 52 weeks

Trial Locations

Locations (1)

Cancer Hospital Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China