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

February 23, 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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

155

Phase

  • 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

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

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
Intervention / Treatment
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

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

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

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 (Estimated)

January 30, 2026

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

September 30, 2029

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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