LymphomaPhase 1NCT07082803
TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas
A Phase 1 study testing TLN-121 and zeprumetostat (TLN-254) in people with Lymphoma and Lymphoma, Non Hodgkin, run by Treeline Biosciences, Inc. at 14 sites in 3 countries.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, Lymphoma, Non Hodgkin
- What is being tested?
- TLN-121 and zeprumetostat (TLN-254)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 14 sitesin 3 countries
- Study dates
- 23 Jun 2025to Nov 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Disease Characteristics
- Participant must have measurable disease at study entry
- Participants must have one of the following histologically documented hematologic malignancies:
- Large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBLC), not otherwise specified (DLBCL, NOS), Follicular lymphoma (FL) grade 3b, transformed lymphoma from FL, or High-Grade B-Cell lymphoma (HGBCL) 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:
Show all 10Show fewer
- Nodal T-follicular helper (Tfh) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (AITL).
- Nodal Tfh cell lymphoma, follicular type; Follicular helper T-cell lymphoma, follicular type.
- Nodal Tfh cell lymphoma, NOS; Follicular helper T-cell lymphoma, NOS.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Who cannot join
- 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.
- 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.
- 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.
- Participant must not have major surgery or severe trauma within 4 weeks prior to the start of the study.
- 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.
- Pregnant or lactating.
- Conditions that could affect drug absorption.
Trial locations and contacts
14 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
14 sites in 3 countries
United States8 sites, 8 recruiting
- Recruiting
The START Center for Cancer Care - Midwest
Grand Rapids, Michigan, 49546
Andrew Sochacki, 616-389-1800, andrew.sochacki@startmidwest.com
- Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
Dai Chihara, Dr., 713-792-2860, DChihara@mdanderson.org
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
Sydney Fitzgerald, 615-339-0516, Sydney.Fitzgerald@scri.com
- Recruiting
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Steven Horwitz, horwitzs@mskcc.org
- Recruiting
Weill Cornell Medicine - New York Presbyterian Hospital
New York, New York, 10065
Erin Mulvey, MD, 646-962-2064, ecm9010@med.cornell.edu
- Recruiting
Stanford Medicine Cancer Center
Palo Alto, California, 94304
Kim, 650-721-7489, k241@stanford.edu
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Stephen Schuster, MD, stephen.schuster@pennmedicine.upenn.edu
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63108
Amalia Dubois, 314-273-1486, amalia@wustl.edu
Australia5 sites, 5 recruiting
- Recruiting
Macquarie University Hospital
Macquarie Park, New South Wales, 2113
Principal Investigator, 02 9812 2956, clinicaltrials@mq.edu.au
- Recruiting
Cabrini Health
Malvern, Victoria, 3144
Principal Investigator, 61 3 9508 3437, clinicaltrials@cabrini.com.au
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria
Principal Investigator, 61 3 8559 5000, PCCTU.HaemB@petermac.org
- Recruiting
Linear Clinical Research
Perth, Western Australia, 6009
Principal Investigator, +61 (08) 6382 5100, actc-management@linear.org.au
- Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
Principal Investigator, 07 3176 1472, David.Barnes2@health.qld.gov.au
Canada1 site, 1 recruiting
- Recruiting
BC Cancer - Vancouver
Vancouver, British Columbia, V5Z 4E6
Principal Investigator, lsehn@bccancer.bc.ca
About this study
Official title: 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
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
- Conditions
- Lymphoma, Lymphoma, Non Hodgkin
- Being tested
- TLN-121, zeprumetostat (TLN-254)
- Keywords
- Relapsed or Refractory Non-Hodgkin Lymphomas
- Medical subject headings
- Lymphoma, Lymphoma, Non-Hodgkin, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TLN-121Drug
Specified dose on specified days.
zeprumetostat (TLN-254)Drug
Specified dose on specified days.
TLN-121Drug
Specified dose on specified days.
| Study group | Role | What they receive |
|---|---|---|
| Single Agent | Experimental | Not described Receives: Drug: TLN-121 |
| Combination Treatment | Experimental | Not described Receives: Drug: zeprumetostat (TLN-254); Drug: TLN-121 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 years
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)
Measured: Up to 2 years
Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
Measured: Up to 2 years
Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
Measured: Up to 2 years
Secondary outcomes (7)
Maximum Observed Plasma Concentration (Cmax) of TLN-121
Measured: Up to 2 years
Time to Maximum Plasma Concentration (Tmax) of TLN-121
Measured: Up to 2 years
Minimum Observed Plasma Concentration (Cmin) of TLN-121
Measured: Up to 2 years
Area Under the Plasma Concentration-Time Curve (AUC) of TLN-121
Measured: 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
Measured: 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
Measured: 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
Measured: Up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start23 Jun 2025
- Primary completionSep 2030 (estimated)
- Study completionNov 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Treeline Biosciences, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082803
- Sponsor's protocol ID
- TLN-121-2501
- Status last verified
- Sep 2026
- First submitted
- 26 Jun 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07082803
- Acronym / sponsor ID
- TLN-121-2501
- Conditions
- Lymphoma, Lymphoma, Non Hodgkin
- Keywords
- Relapsed or Refractory Non-Hodgkin Lymphomas
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Treeline Biosciences, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 Jun 2025 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Nov 2030 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Agent | Experimental | Drug: TLN-121 |
| Combination Treatment | Experimental | Drug: zeprumetostat (TLN-254), Drug: TLN-121 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Disease Characteristics
- Participant must have measurable disease at study entry
- Participants must have one of the following histologically documented hematologic malignancies:
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Key exclusion criteria (7 listed)
- 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.
- 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.
- 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.
- Participant must not have major surgery or severe trauma within 4 weeks prior to the start of the study.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TLN-121Specified dose on specified days. | Drug | Single Agent |
| zeprumetostat (TLN-254)Specified dose on specified days. | Drug | Combination Treatment |
| TLN-121Specified dose on specified days. | Drug | Combination Treatment |
Primary outcome
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.
Time frame: Up to 2 years
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)
Time frame: Up to 2 years
Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
Time frame: Up to 2 years
Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
Time frame: Up to 2 years
7 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of TLN-121
Time frame: Up to 2 years
Time to Maximum Plasma Concentration (Tmax) of TLN-121
Time frame: Up to 2 years
Minimum Observed Plasma Concentration (Cmin) of TLN-121
Time frame: Up to 2 years
Area Under the Plasma Concentration-Time Curve (AUC) of TLN-121
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingObservational study
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
Cutaneous T-cell Lymphoma, Sezary Syndrome
Not yet recruitingPhase 1
Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP) for Previously Untreated Mantle Cell Lymphoma
Ann Arbor Stage II Mantle Cell Lymphoma, Ann Arbor Stage III Mantle Cell Lymphoma
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
14 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TLN-121 and zeprumetostat (TLN-254) in people with Lymphoma and Lymphoma, Non Hodgkin, run by Treeline Biosciences, Inc. at 14 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States, Australia, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Treeline Clinical Operations (857-228-0050, clinicaloperations@treeline.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (time frame: Up to 2 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.