NCT07439653 · TORL Biotherapeutics, LLC
A Study of TORL-5-700 in Relapsed/Refractory Non Hodgkin's Lymphoma
What this study is about
A Phase 1/2 study to evaluate safety, tolerability, and anticancer activity of TORL-5-700 as a treatment given alone and in combination in R/R NHL
View original scientific description
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
Interventions
DRUG
TORL-5-700
Part 1: Monotherapy Dose Escalation - TORL-5-700 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
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
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Burkitt lymphoma and high-grade B-cell lymphoma
- CNS involvement
- Peripheral neuropathy \> Grade 2
- Uncontrolled medical conditions
- Viral infections
Where
- Fullerton, California
- Santa Monica, California
- Stanford, California
- Iowa City, Iowa
- Nashville, Tennessee
- Dallas, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 11, 2026 · Source of record for eligibility and locations