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New treatment option for Lymphoma
Official title A Study of TLN-254 in Participants With Relapsed or Refractory T-cell Lymphoma
ClinicalTrials.gov ID: NCT06733441
What this study is testing
What is TLN-254?
TLN-254 is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary purpose of this study is to evaluate the anti-tumor activity of TLN-254 monotherapy in participants with relapsed or refractory T-cell lymphoma.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age:
- At least 18 years of age at the time of signing the informed consent form (ICF). Type of Participant and Disease Characteristics:
- Cohort 1: Peripheral T-cell lymphoma (PTCL) that has relapsed after, or not responded to at least one prior systemic treatment regimen. Participants...
- Nodal T-follicular helper (TFH) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (angioimmunoblastic...
- Nodal TFH cell lymphoma, follicular type; Follicular helper T-cell lymphoma, follicular type.
You likely can't join if
- Medical Conditions:
- 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...
- Participants must not have any condition, including significant acute or chronic medical illness, active or uncontrolled infection, or the presence...
- Current or past history of central nervous system (CNS) involvement. Other Exclusions:
- Pregnant or lactating women.
- Unable to swallow tablets.
See the full eligibility criteria
- Age:
- At least 18 years of age at the time of signing the informed consent form (ICF). Type of Participant and Disease Characteristics:
- 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...
- 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
- Participant must have measurable disease at study entry.
- Freshly biopsied or archival tissue available. Diagnostic Assessments:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
- Adequate organ function. Contraception:
- Participants must accept and follow the pregnancy prevention plan.
- Medical Conditions:
- 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.
- 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...
- Current or past history of central nervous system (CNS) involvement. Other Exclusions:
- Pregnant or lactating women.
- Unable to swallow tablets.
The study team makes the final eligibility decision.
Where it's taking place
- Stanford, California, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Nashville, Tennessee, United States
- Vancouver, British Columbia, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Stanford, California, United States; St Louis, Missouri, United States; New York, New York, United States; Nashville, Tennessee, United States; Vancouver, British Columbia, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.