Study of TG-1501 in Subjects With Relapsed or Refractory Lymphoma
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Lymphoma, Lymphoma |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2019 |
| Start Date: | March 2019 |
| End Date: | August 2022 |
| Contact: | TG Therapeutics Clinical Support Team |
| Email: | clinicalsupport@tgtxinc.com |
| Phone: | 212-554-4484 |
A Phase 1 Study of TG-1501 in Subjects With Relapsed or Refractory Lymphoma
Phase 1 open label, single-arm, multi-center, dose-escalation study for individuals with
relapsed or refractory classical Hodgkin's Lymphoma or B-cell Non Hodgkin's Lymphoma.
relapsed or refractory classical Hodgkin's Lymphoma or B-cell Non Hodgkin's Lymphoma.
Planned enrollment includes 3 subjects at each dose level. TG-1501 will be administered as a
60-minute IV infusion at fixed dose levels on Days 1 and 15 of every 28-day cycle or only on
Day 1 of every 28-day cycle.
60-minute IV infusion at fixed dose levels on Days 1 and 15 of every 28-day cycle or only on
Day 1 of every 28-day cycle.
Inclusion Criteria:
- Histologically confirmed relapsed or refractory classical Hodgkin lymphoma (cHL) or
B-cell non-Hodgkin lymphoma (NHL).
- Measurable disease and adequate organ function as specified in the protocol
- Life expectancy of at least 3 months
Exclusion Criteria:
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, antibody, or any other
antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint
pathways.
- Subjects receiving cancer therapy or investigational drug within 21 days of Cycle 1
Day 1.
- Prior autologous stem cell transplant within 3 months
- Active Hepatitis B or Hepatitis C
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