Lymphoma, Non-Hodgkin Clinical Trial
Official title:
A Phase I, Multicenter, Open-Label, Single-Arm, Dose-Escalation, Study to Evaluate the Safety, Tolerability, and Antitumor Activity of Continuous Intravenous Infusion of the Bispecific T-Cell Engager MEDI-538 in Adults With B-Cell Non-Hodgkin's Lymphoma Not Eligible for Curative Therapy
- Evaluate the safety and tolerability of multiple doses of MEDI-538 by continuous IV
infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible for curative
therapy.
- Determine the maximum tolerated dose of MEDI-538 administered by continuous IV
infusion.
- Evaluate the safety and tolerability of MEDI-538 at doses of 5, 10, or 15 μg/m2/24h by
continuous IV infusion for 4 or 8 weeks in adult patients with B-cell NHL not eligible
for
- Determine the MTD of MEDI-538 administered by continuous IV infusion for 4 or 8 weeks
in adult patients with B-cell NHL not eligible for curative therapy.
;
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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