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: 2026-06-11
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
ContactTimothy Welliver, M.D. · contact · timothy.welliver@torlbio.com · (310) 598-5969
All locations (3)
UCLARecruiting
Santa Monica, California, United States
Stanford UniversityRecruiting
Stanford, California, United States
Sarah Cannon Research InstituteRecruiting
Nashville, Tennessee, United States