ClinicalTrials.gg
RecruitingNCT07082803Updated Sep 4, 2026

TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas

A Phase 1 interventional study of TLN-121 and zeprumetostat (TLN-254) in Lymphoma and Lymphoma, Non Hodgkin, sponsored by Treeline Biosciences, Inc.. Recruiting at 14 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-04.

Primary conditionLymphoma, Non-HodgkinRegistry: LymphomaReclassifiedWhy we changed it
Registry
Lymphoma — the first condition term the registry derived for this study.
ClinicalTrials.gg
Lymphoma, Non-Hodgkin
Why
  1. The study's listed conditions name Lymphoma, Non-Hodgkin, a narrower term within Lymphoma.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Treeline Biosciences, Inc. · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Jun 2025; still recruiting 1 year 4 months later.
Phase
Phase 1
Study type
Interventional
Enrollment
180
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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

02

Conditions studied

  • Lymphoma
  • Lymphoma, Non Hodgkin

Browse trials for

Keywords

  • Relapsed or Refractory Non-Hodgkin Lymphomas
03

In context

Lymphoma, Non-Hodgkin Reclassified

2,287 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 287 are open to participants now.

This study's planned enrollment of 180 is above the median of 40 across 1,883 interventional studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

Treeline Biosciences, Inc. is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Compared within Lymphoma, Non-Hodgkin, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Lymphoma. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Disease Characteristics

  1. Participant must have at study entry
  2. Participants must have one of the following documented hematologic :

    1. 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 .
    2. FL grade 1-3a that requires treatment following at least 2 prior lines of therapy.
    3. The following Peripheral T-cell lymphoma (PTCL) subtypes that have after, or not responded to at least 1 prior systemic treatment regimen:

      • 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.
  3. (ECOG) performance status of 0 or 1.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. Participant must not have a history of stem cell transplantation within 60 days or allogeneic stem cell transplantation within 90 days prior to the start of the study.
  3. 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.
  4. Participant must not have major surgery or severe trauma within 4 weeks prior to the start of the study.
  5. 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.
  6. Pregnant or lactating.
  7. Conditions that could affect drug absorption.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Measurable disease

The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.

The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Line of therapy

A line of therapy is one course of treatment, which may combine several drugs. First-line is the first course given; second-line follows when that stops working or is not tolerated.

“Two prior lines” means two courses that count separately under the study’s rules — not simply two drugs. Ask the study team if you are unsure how yours are counted.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
180 participants (estimated)

Study arms

  • Experimental
    Single Agent

    Drug: TLN-121

  • Experimental
    Combination Treatment

    Drug: zeprumetostat (TLN-254) · Drug: TLN-121

Interventions

  • DrugTLN-121

    Specified dose on specified days.

  • Specified dose on specified days.

  • DrugTLN-121

    Specified dose on specified days.

06

What researchers measure

Primary outcomes

  1. 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

  2. Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)

    Time frame: Up to 2 years

  3. 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

  4. Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0

    Time frame: Up to 2 years

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax) of TLN-121

    Time frame: Up to 2 years

  2. Time to Maximum Plasma Concentration (Tmax) of TLN-121

    Time frame: Up to 2 years

  3. Minimum Observed Plasma Concentration (Cmin) of TLN-121

    Time frame: Up to 2 years

  4. Area Under the Plasma Concentration-Time Curve (AUC) of TLN-121

    Time frame: Up to 2 years

  5. 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

  6. 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.

  7. 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

07

Study locations

14 of 14 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2025 (actual). Primary completion is estimated for Sep 2030, 63 months after the start.

Of 163 industry-sponsored phase 1 interventional studies under Lymphoma, Non-Hodgkin, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 70. This study's planned 63 months is above that.

Counting every sponsor, half of 286 studies reached it within 53 months; a quarter within 38 and three quarters within 73.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 26, 2025
First posted
Jul 24, 2025
StartActual
Jun 23, 2025
Primary completionEst.
Sep 2030
CompletionEst.
Nov 2030
Last update
Sep 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07082803
Lead sponsor
Treeline Biosciences, Inc.
Responsible party
Sponsor
First posted
Jul 24, 2025
Start date
Jun 23, 2025
Primary completion
Sep 2030 (estimated)
Completion
Nov 2030 (estimated)
Last update
Sep 4, 2026

Study contacts

Treeline Clinical Operations
Contact
clinicaloperations@treeline.bio
857-228-0050

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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