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NCT Number: NCT07439653

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

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

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Key information

Conditions

Histologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, B-Cell Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

UCLA, Santa Monica, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TORL-5-700

Drug

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

TORL-5-700 at MTD/RP2D

Drug

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

Drug

Part 3: Combination Evaluation - TORL-5-700 at MTD/RP2D administered every three weeks in combination with another agent

Primary outcomes

  1. Evaluate the safety of TORL-5-700 as a monotherapy

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

    Assessment of adverse events according to NCI-CTCAE Version 5.0

  2. Assess the antitumor activity of TORL-5-700 as monotherapy

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

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

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

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

    Assessment of adverse events according to NCI-CTCAE Version 5.0

  4. Determine the Maximum Tolerated Dose (MTD)

    Time frame: 21 days from the start of treatment

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

  5. Determine the Recommended Phase 2 Dose (RP2D)

    Time frame: 21 days from the start of treatment

    Determine the RP2D by assessing Protocol defined Dose Limiting Toxicities

Secondary outcomes

  1. Maximum Serum Concentration of TORL-5-700 (Cmax)

    Time frame: though end of study treatment, an average of 5 months

    Pk assessment

  2. 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

    Pk assessment

  3. Terminal Half-life (t1/2) of Serum TORL-5-700

    Time frame: though end of study treatment, an average of 5 months

    Pk assessment

  4. 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

    Pk assessment

  5. 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

    Pk assessment

  6. 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

    Pk assessment

  7. Clearance (CL) of TORL-5-700

    Time frame: though end of study treatment, an average of 5 months

    Pk assessment

  8. Clearance (CL) of TORL-5-700 in combination with other agents

    Time frame: though end of study treatment, an average of 5 months

    Pk assessment

  9. Volume of distribution of TORL-5-700

    Time frame: though end of study treatment, an average of 5 months

    PK assessment

  10. Volume of distribution of TORL-5-700 in combination with other agents

    Time frame: though end of study treatment, an average of 5 months

    PK assessment

  11. Immunogenicity of TORL-5-700

    Time frame: though end of study treatment, an average of 5 months

    Immunogenicity will be measured by incidence of treatment emergent ADAs

  12. Immunogenicity of TORL-5-700 in combination with other agents

    Time frame: though end of study treatment, an average of 5 months

    Immunogenicity will be measured by incidence of treatment emergent ADAs

  13. 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

    Assess the antitumor activity of TORL-5-700 in combination with other agents using Cheson (2014) disease grading criteria

Study contacts

Contact information is provided by the study sponsor or research team.

Timothy Welliver, M.D.

CONTACT

[email protected]

(310) 598-5969

Sponsors and collaborators

Lead sponsor

TORL Biotherapeutics, LLC

Industry

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Feb 27, 2026
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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