RecruitingRecruiting
A Study of TORL-5-700 in Relapsed/Refractory Non Hodgkin's Lymphoma
NCT07439653 · TORL Biotherapeutics, LLC
In plain English
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Official title
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
About this study
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 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
Study design
Enrollment target: 155 participants
Allocation: non_randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-03-31
Estimated completion: 2029-09-30
Last updated: 2026-08-24
Interventions
Drug: TORL-5-700Drug: TORL-5-700 at MTD/RP2DDrug: TORL-5-700 at MTD/RP2D in combination with another agent
Primary outcomes
- • Evaluate the safety of TORL-5-700 as a monotherapy (though study completion, an average of 2.5 years)
- • Assess the antitumor activity of TORL-5-700 as monotherapy (though study completion, an average of 2.5 years)
- • Evaluate the safety of TORL-5-700 in combination with other agents (though study completion, an average of 2.5 years)
Sponsor
TORL Biotherapeutics, LLC · industry
Contacts & investigators
ContactEric Park, M.D. · contact · eric.park@torlbio.com · (310) 598-5969
All locations (6)
Providence Medical FoundationRecruiting
Fullerton, California, United States
UCLARecruiting
Santa Monica, California, United States
Stanford UniversityRecruiting
Stanford, California, United States
University of Iowa Health CareRecruiting
Iowa City, Iowa, United States
Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States