Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)

ImmuneOnco Biopharmaceuticals

Status and phase: Suspended; Phase 1

Conditions: B-cell Non-Hodgkin's Lymphoma

Treatments: Drug: IMM0306

Study type: Interventional

Funder types: Other

Identifiers

NCT04746131

IMM0306

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of IMM0306-02 in patients with refractory or relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL).

Enrollment: 90 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18-75 years old
• Diagnosed with B-NHL
• Relapsed after or be refractory to at least 2 line of standard therapy

Exclusion criteria

• Active central nervous system (CNS) metastases
• Positive Direct Antiglobulin Test (DAT)
• Active autoimmune disorder
• Skin disorders that do not requires hormone replacement therapy

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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90 participants in 1 patient group

IMM0306

Experimental group

Description:

IMM0306 Dose escalation: 0.1mg/kg, 0.2mg/kg, 0.4mg/kg, 0.8mg/kg,1.2mg/kg and 1.6mg/kg through intravenous administration weekly up to 52 weeks.

Treatment:

Drug: IMM0306