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Recruiting NCT07439653

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

Phase I / Phase II Interventional Histologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TORL-5-700, TORL-5-700 at MTD/RP2D, TORL-5-700 at MTD/RP2D in combination with another agent.
Who it may be relevant to
Registry conditions: Histologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin Lymphoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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

Interventions

  • Drug TORL-5-700
    Part 1: Monotherapy Dose Escalation - TORL-5-700 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
  • 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

Primary outcome measures

  • 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]
Secondary outcome measures (12)
  • Maximum Serum Concentration of TORL-5-700 (Cmax) [Time frame: though end of study treatment, an average of 5 months]
  • Maximum Serum Concentration of TORL-5-700 (Cmax) in combination with other agents [Time frame: though end of study treatment, an average of 5 months]
  • Terminal Half-life (t1/2) of Serum TORL-5-700 [Time frame: though end of study treatment, an average of 5 months]
  • Terminal Half-life (t1/2) of Serum TORL-5-700 in combination with other agents [Time frame: though end of study treatment, an average of 5 months]
  • Area under the Serum Concentration -Time curve for TORL-5-700 from the time of dosing to the last measurable concentration [Time frame: though end of study treatment, an average of 5 months]
  • Area under the Serum Concentration -Time curve for TORL-5-700 from the time of dosing to the last measurable concentration in combination with other agents [Time frame: though end of study treatment, an average of 5 months]
  • Clearance (CL) of TORL-5-700 [Time frame: though end of study treatment, an average of 5 months]
  • Clearance (CL) of TORL-5-700 in combination with other agents [Time frame: though end of study treatment, an average of 5 months]
  • Volume of distribution of TORL-5-700 [Time frame: though end of study treatment, an average of 5 months]
  • Volume of distribution of TORL-5-700 in combination with other agents [Time frame: though end of study treatment, an average of 5 months]
  • Immunogenicity of TORL-5-700 [Time frame: though end of study treatment, an average of 5 months]
  • Immunogenicity of TORL-5-700 in combination with other agents [Time frame: though end of study treatment, an average of 5 months]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Sequential
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • UCLA — Santa Monica
  • Stanford University — Stanford
  • Sarah Cannon Research Institute — Nashville

Identifiers

NCT: NCT07439653 · TORL5700-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗