To hear about similar clinical trials, please enter your email below
Trial Title:
Study of IMM0306 in Patients With Relapsed or Refractory CD20-positive B-cell Non-Hodgkin's Lymphoma
NCT ID:
NCT05805943
Condition:
CD20-positive B-cell Non-Hodgkin's Lymphoma
Conditions: Official terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
IMM0306
Description:
IMM0306 is an bi-specific antibody
Arm group label:
IMM0306 Monotherapy
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).
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Cancer Hospital Chinese Academy of Medical Sciences
Address:
City:
Beijing
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuankai Shi
Phone:
010-87788268
Start date:
March 2, 2020
Completion date:
May 25, 2025
Lead sponsor:
Agency:
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Agency class:
Other
Source:
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05805943
