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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2021-11-17

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Escalation

Estimated to be \<31 subjects across multiple centers

Group Type EXPERIMENTAL

TRPH-222

Intervention Type DRUG

administered by IV, 21-day Cycle

Expansion

Estimated to be \<121 subjects across multiple centers

Group Type EXPERIMENTAL

TRPH-222

Intervention Type DRUG

administered by IV, 21-day Cycle

Interventions

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TRPH-222

administered by IV, 21-day Cycle

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No