Dysautonomia International

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

Arm	Description	Assigned 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

UCLA
Santa Monica, California 90404

Stanford University
Stanford, California 94305

Sarah Cannon Research Institute
Nashville, Tennessee 37203

More Details

Status: Recruiting
Sponsor: TORL Biotherapeutics, LLC

Study Contact

Timothy Welliver, M.D.
(310) 598-5969
timothy.welliver@torlbio.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.