Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion
Natalie Galanina, MD

Description

Summary

This is a Phase 1, multi-center, open-label study of TRPH-222 monotherapy in subjects with relapsed and/or refractory B-cell NHL. The study will be conducted in two Stages: Dose-Escalation, Dose-Expansion.

Official Title

Phase 1, Multicenter, Open-Label Study of the Antibody-Drug Conjugate TRPH-222 in Subjects With Relapsed and/or Refractory B-Cell Lymphoma

Keywords

Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoma, Mantle-Cell Lymphoma, Marginal Zone Lymphoma, Large B-Cell, Diffuse Lymphoma, Follicular Antibody-Drug Conjugate ADC CD22 SMARTag™ technology TRPH-222 Immunoconjugates Escalation Expansion

Eligibility

You can join if…

Open to people ages 18 years and up

  • Age ≥ 18 years at the time of signing the informed consent
  • Histologically confirmed (2016 WHO lymphoma classification) B-cell NHL that is DLBCL, FL (including transformed FL), MZL, or MCL
  • Relapsed and/or refractory NHL requiring systemic therapy and have failed, are intolerant to, or are considered ineligible for standard of care anticancer treatments that are known to be potentially curative. Subjects must not be current candidates for HSCT. Participants who refuse standard treatments may also be considered provided that documentation is provided that the subject has been made aware of all therapeutic options
  • Eastern Cooperative Oncology Group (ECOG) status 0-2

You CAN'T join if...

  • Presence of a leukemic phase of the lymphoma
  • "Double hit" or "triple hit" germinal center B cell lymphoma
  • Previous solid organ allograft (except for corneal transplant)
  • Peripheral neuropathy > NCI-CTCAE Grade 1
  • Significant organ dysfunction that would preclude study participation
  • Significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias
  • Any other serious active disease or co-morbid medical condition, according to the Investigator's decision or Medical Monitor, that will substantially increase the risk associated with the subject's participation in the study

Locations

  • University of California San Diego accepting new patients
    San Diego California 92093 United States
  • Banner MD Anderson accepting new patients
    Gilbert Arizona 85234 United States

Lead Scientist

  • Natalie Galanina, MD
    Assistant Clinical Professor, Medicine. Authored (or co-authored) 11 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Triphase Research and Development III Corp.
ID
NCT03682796
Phase
Phase 1
Study Type
Interventional
Last Updated