Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single-arm open label trial to explore the tolerability, safety, PK, PD, and anti-tumor activity of various doses and schedules of CHO-H01 administered as monotherapy in subjects with follicular lymphoma.
Groups of 6 subjects are planned for each cohort. The first 3 patients of each cohort will be evaluated to determine if it is appropriate to proceed with the additional 3 patients at that dose and schedule.
This is a single-arm open label trial to explore the tolerability, safety, PK, PD, and anti-tumor activity of various doses and schedules of CHO-H01 administered as monotherapy in subjects with follicular lymphoma. This is not an MTD study, but an evaluation of optimum biological activity.
Groups of 6 subjects are planned for each cohort. The first 3 patients of each cohort will be evaluated to determine if it is appropriate to proceed with the additional 3 patients at that dose and schedule.
Schema 1:
1 mg/kg administered on D1 of Cycle 1 and D1 of subsequent 28 day cycles. Up to 6 cycles total are planned per subject.
Schema 2-3 Details to be determined after analysis of first 3-6 patients treated on Schema 1. Doses may be either escalated or de-escalated, or modified for Cycles 2-6 relative to Cycle 1. Schedules to be explored could include multiple doses with the first cycle: D1, D8 of 28 day cycles and D1, D8, D15 of 28 days cycles. In no case will individual doses exceed 10mg/kg.
Decisions on whether to proceed with a schema and details of selected dose and schedule will be made during cohort data review meetings by a Clinical-Scientific Review Team (CSRT) comprised of the trial investigators and Medical/Clinical and Safety representatives from the Sponsor. Ad hoc members will be consulted as needed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label treatment | Experimental | Study drug (CHO-H01) administered on Day 1 of 28 day cycles up to 6 cycles total. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHO-H01 | Biological | Glyco-engineered anti-CD20 antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse drug reactions | Treatment-emergent adverse events and clinically significant laboratory values assessed for each subject and aggregated by type, frequency and severity by treatment cohort | 28 days |
| Pharmacodynamic assessment of Immune cell activation | Gene expression of immune cell activation following treatment compared to baseline | 64 days |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical response | Lugano Revised Criteria for Response | 8 weeks |
| Serum drug concentration | Serum drug concentration measured at different times following drug administration |
Not provided
Inclusion Criteria:
Adequate bone marrow function defined by: absolute neutrophil count (ANC) of ≥ 1.5 x 109/L, platelet count of ≥ 100.0 x 109/L, and hemoglobin ≥9.0 g/dL.
Adequate hepatic function defined by: serum total bilirubin < 2 mg/dl (unless resulting from hemolysis), aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 x ULN (or ≤ 5 x ULN in subjects with liver metastases).
Adequate renal function assessed by: serum creatinine within normal limits, or creatinine clearance (by Cockcroft Gault formula) ≥ 50 mL/min for subjects in whom serum creatinine may not adequately reflect renal function.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thomas Dahl, PhD | Contact | 617-818-2735 | tadahl@outlook.com | |
| Andrew Raubitschek, MD | Contact | 626-321-1659 | araubit@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Dahl, PhD | Sponsor GmbH | Study Director |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
Not provided
Not provided
3+3 sequential cohort design
Not provided
Not provided
Not provided
Not provided
| 72 hours |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |