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

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

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.

In Dose Escalation, patients with DLBCL, FL (including transformed FL), MZL, and MCL were to be enrolled per dose cohort. In Dose Expansion, additional response-evaluable patients were to be enrolled in NHL subtype-specific cohorts including DLBCL and FL to confirm the RP2D identified in Escalation. Each stage consisted of screening, baseline, treatment, and follow-up periods. During the treatment period, patients were to be treated indefinitely in 21 day cycles. The EOT assessments were to occur 28 and 60 days after the last study treatment.

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