Follicular Lymphoma Clinical Trial
Official title:
A Phase I Open-label, Multiple Dose Study of CHO-H01 Administered Intravenously as a Single Agent to Subjects With Refractory or Relapsed Follicular Lymphoma
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.
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