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

Last updated: April 6, 2023
Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Lymphoma, B-cell

Treatment

N/A

Clinical Study ID

NCT05805943
IMM0306-I
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Relapsed or refractory CD20-positive B-cell non-Hodgkin's lymphoma (B-NHL) that hasbeen 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

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/monoclonalantibodies 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 beforescreening.

Study Design

Total Participants: 154
Study Start date:
March 02, 2020
Estimated Completion Date:
May 25, 2025

Connect with a study center

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing,
    China

    Active - Recruiting

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