Print this page

Phase 1, Open-label, Dose-escalation and Expansion Study of TNB-486, a Bispecific Antibody Targeting CD19 in Subjects with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma.

Primary:
- Evaluate the safety and tolerability of TNB-486 when administered as monotherapy

- Determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D) for TNB-486 when administered as monotherapy

- Evaluate the pharmacokinetics (PK) of TNB-486 when administered as monotherapy.

Secondary:
- Evaluate the clinical activity of TNB-486 when administered as monotherapy.

- Evaluate anti-drug antibody titers for TNB-486 when administered as monotherapy

Exploratory:
- Evaluate pharmacodynamic and exploratory biomarkers and assess their association with safety, pharmacokinetics, and clinical activity.

Protocol Number: 012302
Phase: Phase I
Applicable Disease Sites: Non-Hodgkin's Lymphoma
Drugs Involved: TNB-486
Principal Investigator: Matthew Matasar
Scope: National
Therapies Involved: Chemotherapy single agent systemic
Participating Institutions:
  • Rutgers University
Inclusion & Exclusion Criteria

Please note that we have obtained the inclusion and exclusion criteria information from the National Institutes of Health’s clinical trials web site ClinicalTrials.gov. The listed criteria may not necessarily reflect recent amendments to the protocol and the current criteria.

For further information about clinical trials, please contact us at 732-235-7356.