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

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

Status
Suspended
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04746131
Enrollment
90
Registered
2021-02-09
Start date
2021-01-15
Completion date
2024-04-11
Last updated
2022-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell Non-Hodgkin's Lymphoma

Keywords

IMM0306

Brief summary

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).

Interventions

DRUGIMM0306

IMM0306 is an bi-specific antibody

Sponsors

Worldwide Clinical Trials
CollaboratorOTHER
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Maximum Tolerated Dose (MTD) of IMM0306 as measured by incidence of DLTs (Dose Limiting Toxicity)End of Study (52 Weeks)DLT is defined as one of the following toxicities occurring during the DLT assessment for Cycle 1.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026