New pill takes on tough lymphoma: early trial seeks tumor shrinkage
NCT ID NCT06733441
First seen Jun 24, 2026 · Last updated Aug 19, 2026 · Updated 4 times
Summary
This early-phase trial tests an oral drug called TLN-254 in about 50 adults with relapsed or refractory T-cell lymphoma. The main goal is to see if the drug can shrink tumors and how safe it is. Participants take the drug by mouth on a set schedule, and researchers will monitor responses and side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TLN-254 (an oral drug)
- What this could lead to
- If it works, this could point toward a new treatment option for people with T-cell lymphoma that has not responded to other therapies.
- What could go wrong
- This is an early Phase 1b trial with only 50 participants, so results are preliminary. The drug may not shrink tumors or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 50 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2024
- Expected to finish
-
Nov 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Age: 1. At least 18 years of age at the time of signing the informed consent form (ICF). Type of Participant and Disease Characteristics: 2. Cohort 1: Peripheral T-cell lymphoma (PTCL) that has relapsed after, or not responded to at least one prior systemic treatment regimen. Participants with Anaplastic large cell lymphoma (ALCL) should have received prior brentuximab vedotin treatment. * Nodal T-follicular helper (TFH) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma). * Nodal TFH cell lymphoma, follicular type; Follicular helper T-cell lymphoma, follicular type. * Nodal TFH cell lymphoma, not otherwise specified (NOS); Follicular helper T-cell lymphoma, NOS. * PTCL, NOS. * Anaplastic large-cell lymphoma, Alkaline phosphatase (ALK) positive. * Anaplastic large-cell lymphoma, ALK negative. Cohort 2: Relapsed/refractory CTCL which has relapsed after, or not responded to at least two prior systemic treatments. * Sezary syndrome * Mycosis fungoides 3. Participant must have measurable disease at study entry. 4. Freshly biopsied or archival tissue available. Diagnostic Assessments: 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2. 6. Adequate organ function. Contraception: 7. Participants must accept and follow the pregnancy prevention plan. Exclusion Criteria: Medical Conditions: 1. Participants must not have prior systemic anti-cancer treatment less than or equal to (≤) 5 half-lives or 4 weeks, allogeneic SCT≤90 days or autologous SCT ≤60 days prior to study intervention initiation. 2. Participants must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence of laboratory abnormalities, that places participants at unacceptable risk if participating in this study. 3. Current or past history of central nervous system (CNS) involvement. Other Exclusions: * Pregnant or lactating women. * Unable to swallow tablets.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
British Columbia Cancer Agency
Vancouver, British Columbia, Canada
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
-
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
-
Stanford Cancer Institute
Stanford, California, 94305, United States
-
Washington University School of Medicine
St Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Mitochondria-Targeting drug gamitrinib tested for first time in humans
- Reprogrammed immune cells target CD30-Positive lymphoma in early trial
- Can an experimental pill boost cancer immunotherapy? early trial puts HG146 to the test
- Double-Drug attack on Hard-to-Treat lymphomas
- Chemotherapy plus immunotherapy tested against rare EBV-Driven immune storm
- Can a calming drug make cord blood transplants safer?