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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: TLN-254 Single Agent | Experimental |
| |
| Cohort 2: TLN-254 Single Agent | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLN-254 | Drug | TLN-254 will be administered orally at a specified dose on specified days depending on treatment allocation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Objective Response | Up to 2 years | |
| Percentage of Participants With CR | Up to 2 years | |
| Percentage of Participants With PR | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Up to 2 years | |
| Number of Participants With Severity of TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0 |
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Inclusion 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 brentuximab vedotin treatment.
Cohort 2: Relapsed/refractory CTCL which has relapsed after, or not responded to at least two prior systemic treatments.
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.
Exclusion Criteria:
Medical Conditions:
Other Exclusions:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Treeline Clinical Operations | Contact | 857-228-0050 | clinicaloperations@treeline.bio |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Institute | Recruiting | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D012008 | Recurrence |
| D016410 | Lymphoma, T-Cell, Cutaneous |
| D016411 | Lymphoma, T-Cell, Peripheral |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| TLN-254 | Drug | TLN-254 will be administered orally at a specified dose on specified days. |
|
| Up to 2 years |
| Plasma concentrations of TLN-254 | Day 1 of Cycle 1 and Day 1 of each even numbered Cycle for up to 2 years (Each Cycle length =28 days) |
| Duration of Response (DOR) | Up to 2 years |
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63110 | United States |
|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
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| Sarah Cannon Research Institute | Recruiting | Nashville | Tennessee | 37203 | United States |
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| British Columbia Cancer Agency | Recruiting | Vancouver | British Columbia | Canada |
|
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |