Histologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin LymphomaPhase 1/2NCT07439653
A Study of TORL-5-700 in Relapsed/Refractory Non Hodgkin's Lymphoma
A Phase 1/2 study testing TORL-5-700, TORL-5-700 at MTD/RP2D and TORL-5-700 at MTD/RP2D in combination with another agent in people with Histologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin Lymphoma, run by TORL Biotherapeutics, LLC at 9 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Histologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
- What is being tested?
- TORL-5-700, TORL-5-700 at MTD/RP2D and TORL-5-700 at MTD/RP2D in combination with another agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 9 sitesUnited States
- Study dates
- 31 Mar 2026to 30 Sep 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
United States9 sites, 9 recruiting
- Recruiting
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
- Recruiting
Providence Medical Foundation
Fullerton, California, 92835
- Recruiting
University of Iowa Health Care
Iowa City, Iowa, 52242
- Recruiting
Cancer and Blood Specialty Clinic, Los Alamitos
Los Alamitos, California, 90720
- Recruiting
University of California Miami, Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
- Recruiting
UCLA
Santa Monica, California, 90404
- Recruiting
Stanford University
Stanford, California, 94305
- Recruiting
Cancer Center of Kansas, Wichita
Wichita, Kansas, 67214
About this study
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
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
- Being tested
- TORL-5-700, TORL-5-700 at MTD/RP2D, TORL-5-700 at MTD/RP2D in combination with another agent
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TORL-5-700Drug
Part 1: Monotherapy Dose Escalation - TORL-5-700 Administered once every three weeks
TORL-5-700 at MTD/RP2DDrug
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 agentDrug
Part 3: Combination Evaluation - TORL-5-700 at MTD/RP2D administered every three weeks in combination with another agent
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Monotherapy Dose Escalation | Experimental | TORL-5-700 Administered once every three weeks Receives: Drug: TORL-5-700 |
| Part 2: Monotherapy Expansion | Experimental | TORL-5-700 at MTD/RP2D Administered once every three weeks Receives: Drug: TORL-5-700 at MTD/RP2D |
| Part 3: Combination Evaluation | Experimental | TORL-5-700 at MTD/RP2D Administered once every three weeks in combination with another agent Receives: Drug: TORL-5-700 at MTD/RP2D in combination with another agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety of TORL-5-700 as a monotherapy
Assessment of adverse events according to NCI-CTCAE Version 5.0
Measured: 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
Measured: 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
Measured: 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)
Measured: 21 days from the start of treatment
Determine the Recommended Phase 2 Dose (RP2D)
Determine the RP2D by assessing Protocol defined Dose Limiting Toxicities
Measured: 21 days from the start of treatment
Secondary outcomes (13)
Maximum Serum Concentration of TORL-5-700 (Cmax)
Pk assessment
Measured: though end of study treatment, an average of 5 months
Maximum Serum Concentration of TORL-5-700 (Cmax) in combination with other agents
Pk assessment
Measured: though end of study treatment, an average of 5 months
Terminal Half-life (t1/2) of Serum TORL-5-700
Pk assessment
Measured: 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
Pk assessment
Measured: 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
Pk assessment
Measured: 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
Pk assessment
Measured: though end of study treatment, an average of 5 months
Clearance (CL) of TORL-5-700
Pk assessment
Measured: though end of study treatment, an average of 5 months
Clearance (CL) of TORL-5-700 in combination with other agents
Pk assessment
Measured: though end of study treatment, an average of 5 months
Volume of distribution of TORL-5-700
PK assessment
Measured: though end of study treatment, an average of 5 months
Volume of distribution of TORL-5-700 in combination with other agents
PK assessment
Measured: though end of study treatment, an average of 5 months
Immunogenicity of TORL-5-700
Immunogenicity will be measured by incidence of treatment emergent ADAs
Measured: though end of study treatment, an average of 5 months
Immunogenicity of TORL-5-700 in combination with other agents
Immunogenicity will be measured by incidence of treatment emergent ADAs
Measured: though end of study treatment, an average of 5 months
Assess the preliminary antitumor activity of TORL-5-700 in combination with other agents
Assess the antitumor activity of TORL-5-700 in combination with other agents using Cheson (2014) disease grading criteria
Measured: though study completion, an average of 2.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start31 Mar 2026
- Primary completion31 Mar 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Histologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TORL Biotherapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439653
- Sponsor's protocol ID
- TORL5700-001
- Status last verified
- Aug 2026
- First submitted
- 10 Feb 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07439653
- Acronym / sponsor ID
- TORL5700-001
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- TORL Biotherapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2026 (actual)
- Primary completion
- 31 Mar 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Part 1: Monotherapy Dose Escalation | Experimental | Drug: TORL-5-700TORL-5-700 Administered once every three weeks |
| Part 2: Monotherapy Expansion | Experimental | Drug: TORL-5-700 at MTD/RP2DTORL-5-700 at MTD/RP2D Administered once every three weeks |
| Part 3: Combination Evaluation | Experimental | Drug: TORL-5-700 at MTD/RP2D in combination with another agentTORL-5-700 at MTD/RP2D Administered once every three weeks in combination with another agent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- T-cell lymphoma
- CLL or SL
- Burkitt lymphoma and high-grade B-cell lymphoma
- CNS involvement
- Peripheral neuropathy > Grade 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TORL-5-700Part 1: Monotherapy Dose Escalation - TORL-5-700 Administered once every three weeks | Drug | Part 1: Monotherapy Dose Escalation |
| TORL-5-700 at MTD/RP2DPart 2: Monotherapy Expansion - TORL-5-700 at Maximum tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) Administered once every three weeks | Drug | Part 2: Monotherapy Expansion |
| TORL-5-700 at MTD/RP2D in combination with another agentPart 3: Combination Evaluation - TORL-5-700 at MTD/RP2D administered every three weeks in combination with another agent | Drug | Part 3: Combination Evaluation |
Primary outcome
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
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
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
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)
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
13 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TORL-5-700, TORL-5-700 at MTD/RP2D and TORL-5-700 at MTD/RP2D in combination with another agent in people with Histologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin Lymphoma, run by TORL Biotherapeutics, LLC at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric Park, M.D. ((310) 598-5969, eric.park@torlbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety of TORL-5-700 as a monotherapy (time frame: though study completion, an average of 2.5 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.