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

ImmuneOnco Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: CD20-positive B-cell Non-Hodgkin's Lymphoma

Treatments: Drug: IMM0306

Study type: Interventional

Funder types: Other

Identifiers

NCT05805943

IMM0306-I

Details and patient eligibility

About

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).

Enrollment: 154 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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154 participants in 1 patient group

IMM0306 Monotherapy

Experimental group

Description:

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.

Treatment:

Drug: IMM0306