CD20-positive B-cell Non-Hodgkin's Lymphoma
Conditions
Brief 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).
Interventions
DRUGIMM0306
IMM0306 is an bi-specific antibody
Sponsors
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity | Evaluated for DLTs during the first 28-day cycle |
| Complete response rate | up to 52 weeks |
Countries
China
Outcome results
None listed