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RecruitingInterventionalPhase 1/Phase 2

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

NCT ID: NCT07439653Sponsor: TORL Biotherapeutics, LLCLast updated: 2026-06-11

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

Arms & interventions

  • DrugTORL-5-700

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

  • DrugTORL-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

  • DrugTORL-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

Outcome measures

Primary

  • Evaluate the safety of TORL-5-700 as a monotherapy

    Assessment of adverse events according to NCI-CTCAE Version 5.0

    Time frame: though study completion, an average of 2.5 years

  • Assess the antitumor activity of TORL-5-700 as monotherapy

    Assess the antitumor activity of TORL-5-700 using Cheson (2014) disease grading criteria

    Time frame: though study completion, an average of 2.5 years

  • Evaluate the safety of TORL-5-700 in combination with other agents

    Assessment of adverse events according to NCI-CTCAE Version 5.0

    Time frame: though study completion, an average of 2.5 years

  • Determine the Maximum Tolerated Dose (MTD)

    Determine the MTD by assessing Protocol defined Dose Limiting Toxicities (DLT)

    Time frame: 21 days from the start of treatment

  • Determine the Recommended Phase 2 Dose (RP2D)

    Determine the RP2D by assessing Protocol defined Dose Limiting Toxicities

    Time frame: 21 days from the start of treatment

Secondary

  • 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

  • Assess the preliminary antitumor activity of TORL-5-700 in combination with other agents

    Time frame: though study completion, an average of 2.5 years

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy 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 locations (3)

UCLA

Santa Monica, California, 90404

Recruiting

Stanford University

Stanford, California, 94305

Recruiting

Sarah Cannon Research Institute

Nashville, Tennessee, 37203

Recruiting