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

Purpose

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

Condition

  • Histologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Part 1: Monotherapy Dose Escalation 		TORL-5-700 Administered once every three weeks
  • Drug: TORL-5-700
    Part 1: Monotherapy Dose Escalation - TORL-5-700 Administered once every three weeks
Experimental
Part 2: Monotherapy Expansion 		TORL-5-700 at MTD/RP2D Administered once every three weeks
  • Drug: TORL-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
Experimental
Part 3: Combination Evaluation 		TORL-5-700 at MTD/RP2D Administered once every three weeks in combination with another agent
  • Drug: TORL-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

Recruiting Locations

Providence Medical Foundation
Fullerton, California 92835

UCLA
Santa Monica, California 90404

Stanford University
Stanford, California 94305

University of Iowa Health Care
Iowa City, Iowa 52242

Sarah Cannon Research Institute
Nashville, Tennessee 37203

University of Texas Southwestern Medical Center
Dallas, Texas 75390

More Details

Status
Recruiting
Sponsor
TORL Biotherapeutics, LLC

Study Contact

Eric Park, M.D.
(310) 598-5969
eric.park@torlbio.com