Study of TRPH-222 in Patients With Relapsed and/or Refractory B-Cell Lymphoma

• Status: Recruiting
• Trial end date: 2022-08-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Triphase Research and Development III Corp.

Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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