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

June 9, 2026 updated by: TORL Biotherapeutics, LLC

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
155

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Recruiting
        • UCLA
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Part 1: Monotherapy Dose Escalation
TORL-5-700 Administered once every three weeks
Drug: TORL-5-700
Part 1: Monotherapy Dose Escalation - TORL-5-700 Administered once every three weeks
Experimental: Part 2: Monotherapy Expansion
TORL-5-700 at MTD/RP2D 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
Experimental: Part 3: Combination Evaluation
TORL-5-700 at MTD/RP2D Administered once every three weeks in combination with another agent
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
Assess the antitumor activity of TORL-5-700 using Cheson (2014) disease grading criteria
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
Assessment of adverse events according to NCI-CTCAE Version 5.0
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 MTD by assessing Protocol defined Dose Limiting Toxicities (DLT)
21 days from the start of treatment
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
21 days from the start of treatment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Maximum Serum Concentration of TORL-5-700 (Cmax)
Time Frame: though end of study treatment, an average of 5 months
Pk assessment
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
Pk assessment
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
Pk assessment
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
Pk assessment
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
Pk assessment
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
Pk assessment
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
Pk assessment
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
Pk assessment
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
PK assessment
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
PK assessment
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 will be measured by incidence of treatment emergent ADAs
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
Immunogenicity will be measured by incidence of treatment emergent ADAs
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
Assess the antitumor activity of TORL-5-700 in combination with other agents using Cheson (2014) disease grading criteria
though study completion, an average of 2.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
TORL Biotherapeutics, LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TORL5700-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

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Locations

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