Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2026-01-02 @ 5:48 AM
Study NCT ID:
NCT07082803
Status:
RECRUITING
Last Update Posted:
2025-12-23
First Post:
2025-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-06-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2030-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-22', 'studyFirstSubmitDate': '2025-06-26', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)', 'timeFrame': 'Up to 2 years'}, {'measure': 'Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0', 'timeFrame': 'Up to 2 years'}, {'measure': 'Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0', 'timeFrame': 'Up to 2 years'}], 'secondaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax) of TLN-121', 'timeFrame': 'Up to 2 years'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of TLN-121', 'timeFrame': 'Up to 2 years'}, {'measure': 'Minimum Observed Plasma Concentration (Cmin) of TLN-121', 'timeFrame': 'Up to 2 years'}, {'measure': 'Area Under the Plasma Concentration-Time Curve (AUC) of TLN-121', 'timeFrame': 'Up to 2 years'}, {'measure': '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', 'timeFrame': 'Up to 2 years'}, {'measure': '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', 'timeFrame': 'Up to 2 years.'}, {'measure': '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', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Relapsed or Refractory Non-Hodgkin Lymphomas'], 'conditions': ['Lymphoma', 'Lymphoma, Non Hodgkin']}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nDisease Characteristics\n\n1. Participant must have measurable disease at study entry\n2. Participants must have one of the following histologically documented hematologic malignancies:\n\n 1. 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.\n 2. FL grade 1-3a that requires treatment following at least 2 prior lines of therapy.\n 3. The following Peripheral T-cell lymphoma (PTCL) subtypes that have relapsed after, or not responded to at least 1 prior systemic treatment regimen:\n\n * Nodal T-follicular helper (Tfh) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (AITL).\n * Nodal Tfh cell lymphoma, follicular type; Follicular helper T-cell lymphoma, follicular type.\n * Nodal Tfh cell lymphoma, NOS; Follicular helper T-cell lymphoma, NOS.\n3. High-Grade B-Cell Lymphoma that has relapsed after, or not responded to at least 2 prior systemic treatment regimens.\n4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n1. Participants must not have current central nervous system (CNS) involvement. Participants with past history of CNS involvement of lymphoma must have had CNS disease fully treated with no evidence of recurrence within 12 months.\n2. Participant must not have a history of autologous stem cell transplantation within 60 days or allogeneic stem cell transplantation within 90 days prior to the start of the study.\n3. Participant must not have a history of CAR T-cell or other T-cell targeting treatment ≤ 4 weeks prior to the start of the study.\n4. Participant must not have major surgery or severe trauma within 4 weeks prior to the start of the study.\n5. 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.\n6. Pregnant or lactating.\n7. Conditions that could affect drug absorption.'}, 'identificationModule': {'nctId': 'NCT07082803', 'briefTitle': 'TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas', 'organization': {'class': 'INDUSTRY', 'fullName': 'Treeline Biosciences, Inc.'}, 'officialTitle': 'An Open-Label, Multicenter, Phase 1 Trial to Evaluate the Safety, Pharmacokinetics, and Anti-Tumor Activity of TLN-121 as a Single Agent and in Combination With Other Anti-Lymphoma Agents, in Patients With Relapsed or Refractory Non-Hodgkin Lymphomas', 'orgStudyIdInfo': {'id': 'TLN-121-2501'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Agent', 'interventionNames': ['Drug: TLN-121']}, {'type': 'EXPERIMENTAL', 'label': 'Combination Treatment', 'interventionNames': ['Drug: TLN-254', 'Drug: TLN-121']}], 'interventions': [{'name': 'TLN-121', 'type': 'DRUG', 'description': 'Specified dose on specified days.', 'armGroupLabels': ['Single Agent']}, {'name': 'TLN-254', 'type': 'DRUG', 'description': 'Specified dose on specified days.', 'armGroupLabels': ['Combination Treatment']}, {'name': 'TLN-121', 'type': 'DRUG', 'description': 'Specified dose on specified days.', 'armGroupLabels': ['Combination Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49546', 'city': 'Grand Rapids', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Andrew Sochacki', 'role': 'CONTACT', 'email': 'andrew.sochacki@startmidwest.com', 'phone': '616-389-1800'}], 'facility': 'The START Center for Cancer Care - Midwest', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '63108', 'city': 'St Louis', 'state': 'Missouri', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Amalia Dubois', 'role': 'CONTACT', 'email': 'amalia@wustl.edu', 'phone': '314-273-1486'}], 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'Sydney.Fitzgerald@scri.com', 'phone': '(615) 339-0516'}], 'facility': 'SCRI Oncology Partners', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Dai Chihara, Dr.', 'role': 'CONTACT', 'email': 'DChihara@mdanderson.org', 'phone': '713-792-2860'}], 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '2113', 'city': 'Macquarie Park', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'clinicaltrials@mq.edu.au', 'phone': '02 9812 2956'}], 'facility': 'Macquarie University Hospital', 'geoPoint': {'lat': -33.78105, 'lon': 151.12757}}, {'zip': '4102', 'city': 'Woolloongabba', 'state': 'Queensland', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'David.Barnes2@health.qld.gov.au', 'phone': '07 3176 1472'}], 'facility': 'Princess Alexandra Hospital', 'geoPoint': {'lat': -27.48855, 'lon': 153.03655}}, {'zip': '3144', 'city': 'Malvern', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'clinicaltrials@cabrini.com.au', 'phone': '61 3 9508 3437'}], 'facility': 'Cabrini Health', 'geoPoint': {'lat': -37.86259, 'lon': 145.02811}}, {'city': 'Melbourne', 'state': 'Victoria', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'PCCTU.HaemB@petermac.org', 'phone': '61 3 8559 5000'}], 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.814, 'lon': 144.96332}}, {'zip': '6009', 'city': 'Perth', 'state': 'Western Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Principal Investigator', 'role': 'CONTACT', 'email': 'actc-management@linear.org.au', 'phone': '+61 (08) 6382 5100'}], 'facility': 'Linear Clinical Research', 'geoPoint': {'lat': -31.95224, 'lon': 115.8614}}, {'zip': 'V5Z 4E6', 'city': 'Vancouver', 'state': 'British Columbia', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Laurie Sehn', 'role': 'CONTACT', 'email': 'lsehn@bccancer.bc.ca', 'phone': '604-877-6000'}], 'facility': 'BC Cancer - Vancouver', 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'centralContacts': [{'name': 'Treeline Clinical Operations', 'role': 'CONTACT', 'email': 'clinicaloperations@treeline.bio', 'phone': '857-228-0050'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Treeline Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}