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

Triphase Research and Development III

Status and phase: Completed; Phase 1

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

Treatments: Drug: TRPH-222

Study type: Interventional

Funder types: Industry

Identifiers

NCT03682796

TRPH-222-100

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

Escalation

Experimental group

Description:

Estimated to be \<31 subjects across multiple centers

Treatment:

Drug: TRPH-222

Expansion

Experimental group

Description:

Estimated to be \<121 subjects across multiple centers

Treatment:

Drug: TRPH-222