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The primary purpose of this study is to evaluate the safety, pharmacokinetics,, and preliminary anti-tumor activity of TLN-121 as a single agent and in combination with other anti-lymphoma therapies in patients with relapsed or refractory Non-Hodgkin Lymphomas
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Agent | Experimental |
| |
| Combination Treatment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TLN-121 | Drug | Specified dose on specified days. |
| |
| TLN-254 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants experiencing adverse events (AEs) that meet protocol-defined dose-limiting toxicity (DLT) criteria following administration of TLN-121 alone or in combination with TLN-254. | Up to 2 years | |
| Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) | Up to 2 years | |
| Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0 | Up to 2 years | |
| Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0 | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of TLN-121 | Up to 2 years | |
| Time to Maximum Plasma Concentration (Tmax) of TLN-121 | Up to 2 years | |
| Minimum Observed Plasma Concentration (Cmin) of TLN-121 |
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Inclusion Criteria:
Disease Characteristics
Participant must have measurable disease at study entry
Participants must have one of the following histologically documented hematologic malignancies:
Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (DLBCL, NOS), Follicular lymphoma (FL) grade 3b, or transformed lymphoma from FL following at least 2 prior lines of therapy.
FL grade 1-3a that requires treatment following at least 2 prior lines of therapy.
The following Peripheral T-cell lymphoma (PTCL) subtypes that have relapsed after, or not responded to at least 1 prior systemic treatment regimen:
High-Grade B-Cell Lymphoma that has relapsed after, or not responded to at least 2 prior systemic treatment regimens.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion Criteria:
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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 Medicine Cancer Center | Recruiting | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| Drug |
Specified dose on specified days. |
|
| TLN-121 | Drug | Specified dose on specified days. |
|
| Up to 2 years |
| Area Under the Plasma Concentration-Time Curve (AUC) of TLN-121 | Up to 2 years |
| Anti-tumor activity of TLN-121 and TLN-121 in combination with TLN-254 by evaluating the objective response rate (ORR) according to the Lugano response criteria for Non-Hodgkin Lymphoma | Up to 2 years |
| Anti-tumor activity of TLN-121 and TLN-121 in combination with TLN-254 by evaluating the complete response rate (CR) according to the Lugano response criteria for Non-Hodgkin Lymphoma | Up to 2 years. |
| Anti-tumor activity of TLN-121 and TLN-121 in combination with TLN-254 by evaluating the duration of response (DOR) as assessed by the time from the date of first objective response to the date of disease progression | Up to 2 years |
| The START Center for Cancer Care - Midwest | Recruiting | Grand Rapids | Michigan | 49546 | United States |
|
| Washington University School of Medicine | Recruiting | St Louis | Missouri | 63108 | United States |
|
| Memorial Sloan Kettering Cancer Center | Recruiting | New York | New York | 10065 | United States |
|
| Weill Cornell Medicine - New York Presbyterian Hospital | Recruiting | New York | New York | 10065 | United States |
|
| SCRI Oncology Partners | Recruiting | Nashville | Tennessee | 37203 | United States |
|
| The University of Texas MD Anderson Cancer Center | Recruiting | Houston | Texas | 77030 | United States |
|
| Macquarie University Hospital | Recruiting | Macquarie Park | New South Wales | 2113 | Australia |
|
| Princess Alexandra Hospital | Recruiting | Woolloongabba | Queensland | 4102 | Australia |
|
| Cabrini Health | Recruiting | Malvern | Victoria | 3144 | Australia |
|
| Peter MacCallum Cancer Centre | Recruiting | Melbourne | Victoria | Australia |
|
| Linear Clinical Research | Recruiting | Perth | Western Australia | 6009 | Australia |
|
| BC Cancer - Vancouver | Recruiting | Vancouver | British Columbia | V5Z 4E6 | 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 |