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

Completed · Phase 1

Conditions studied: Lymphoma, Lymphoma, B-Cell, Lymphoma, Non-Hodgkin, Lymphoma, Mantle-Cell, Lymphoma, Marginal Zone, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular

In brief

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.

Key facts

Study ID

NCT03682796

Run by

Triphase Research and Development III Corp.

People needed

32

Starts

2018-10-15

Expected to finish

2021-11-17

Last updated by the study team

2022-05-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify 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

Where it is running

• Banner MD Anderson — Gilbert, Arizona, United States
• Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States
• Ohio State University Comprehensive Cancer Center — Columbus, Ohio, United States
• Abramson Cancer Center of the University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Sarah Cannon Research Institute at Tennessee Oncology — Nashville, Tennessee, United States
• Princess Margaret Cancer Centre — Toronto, Ontario, Canada
• Jewish General Hospital — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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