A Phase 1/2, First-in-Human, Open-Label, Multicenter Study of TORL-5-700 as a Monotherapy and in Combination for Participants With Relapsed or Refractory Non-Hodgkin Lymphoma

TORL Biotherapeutics, LLC

Summary

A Phase 1/2 study to evaluate safety, tolerability, and anticancer activity of TORL-5-700 as a monotherapy and in combination in R/R NHL

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

Inclusion Criteria: * Confirmed B-NHL, including but not limited to de novo DLBCL; FL, Grades 1 to 3A; MCL; transformed lymphoma (tFL, RT) and FL Grade 3B; MZL and MALT. * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2. * At least 1 measurable lesion per Lugano criteria. * Tumor tissue is available. * Adequate organ function Exclusion Criteria: * T-cell lymphoma * CLL or SL * Burkitt lymphoma and high-grade B-cell lymphoma * CNS involvement * Peripheral neuropathy \> Grade 2 * Uncontrolled medical conditions * Viral infections

Interventions

Drug
TORL-5-700
Part 1: Monotherapy Dose Escalation - TORL-5-700 Administered once every three weeks
Drug
TORL-5-700 at MTD/RP2D

Locations (6)

Providence Medical Foundation
Fullerton, California
UCLA
Santa Monica, California
Stanford University
Stanford, California
University of Iowa Health Care
Iowa City, Iowa
Sarah Cannon Research Institute
Nashville, Tennessee
University of Texas Southwestern Medical Center
Dallas, Texas