Recruiting
Phase 1
Phase 2

TORL-5-700

Sponsor:

TORL Biotherapeutics, LLC

Code:

NCT07439653

Conditions

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

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

TORL-5-700

TORL-5-700 at MTD/RP2D

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

Study Details

Brief 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

Conditions

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

Study ID

NCT07439653

Start date

Mar 31, 2026

Status verified date

Aug, 2026

Completion date

Sep 30, 2029

Anticipated

Primary completion date

Mar 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

155 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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

experimental: Part 3: Combination Evaluation

TORL-5-700 at MTD/RP2D Administered once every three weeks in combination with another agent

Interventions

TORL-5-700

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

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

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

Primary outcome measure

  • Evaluate the safety of TORL-5-700 as a monotherapy [ Time Frame: though study completion, an average of 2.5 years ]
  • Assess the antitumor activity of TORL-5-700 as monotherapy [ Time Frame: though study completion, an average of 2.5 years ]
  • Evaluate the safety of TORL-5-700 in combination with other agents [ Time Frame: though study completion, an average of 2.5 years ]
  • Determine the Maximum Tolerated Dose (MTD) [ Time Frame: 21 days from the start of treatment ]
  • Determine the Recommended Phase 2 Dose (RP2D) [ Time Frame: 21 days from the start of treatment ]

Central Contacts and Locations

Central contacts

Eric Park, M.D.

(310) 598-5969eric.park@torlbio.com

Locations

Providence Medical Foundation

Recruiting

Fullerton, California, United States, 92835

Cancer and Blood Specialty Clinic, Los Alamitos

Recruiting

Los Alamitos, California, United States, 90720

UCLA

Recruiting

Santa Monica, California, United States, 90404

Stanford University

Recruiting

Stanford, California, United States, 94305

University of California Miami, Sylvester Comprehensive Cancer Center

Recruiting

Miami, Florida, United States, 33136

University of Iowa Health Care

Recruiting

Iowa City, Iowa, United States, 52242

Cancer Center of Kansas, Wichita

Recruiting

Wichita, Kansas, United States, 67214

Sarah Cannon Research Institute

Recruiting

Nashville, Tennessee, United States, 37203

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

More Information

Sponsor

TORL Biotherapeutics, LLC

Last update posted

Sep 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by TORL Biotherapeutics, LLC on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.