RecruitingPhase 1Phase 2NCT07439653

A Study of TORL-5-700 in Relapsed/Refractory Non Hodgkin's Lymphoma

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


Sponsor

TORL Biotherapeutics, LLC

Enrollment

155 participants

Start Date

Mar 31, 2026

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGTORL-5-700

Part 1: Monotherapy Dose Escalation - TORL-5-700 Administered once every three weeks

DRUGTORL-5-700 at MTD/RP2D

Part 2: Monotherapy Expansion - TORL-5-700 at Maximum tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) Administered once every three weeks

DRUGTORL-5-700 at MTD/RP2D in combination with another agent

Part 3: Combination Evaluation - TORL-5-700 at MTD/RP2D administered every three weeks in combination with another agent


Locations(3)

UCLA

Santa Monica, California, United States

Stanford University

Stanford, California, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07439653