A Study of TLN-254 in Participants With Relapsed or Refractory T-cell Lymphoma
ConditionLymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorTreeline Biosciences, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
At least 18 years of age at the time of signing the informed consent form (ICF).
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.
Nodal T-follicular helper (TFH) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma).
Nodal TFH cell lymphoma, follicular type; Follicular helper T-cell lymphoma, follicular type.
Disqualifiers
Participants must not have prior systemic anti-cancer treatment less than or equal to (≤) 5 half-lives or 4 weeks, allogeneic SCT≤90 days or autologous SCT ≤60 days prior to study intervention initiation.
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.
Current or past history of central nervous system (CNS) involvement.
Pregnant or lactating women.
Trial design
Design model
Parallel
Treatments tested in this trial
TLN-254
DrugTLN-254 will be administered orally at a specified dose on specified days depending on treatment allocation.
TLN-254
DrugTLN-254 will be administered orally at a specified dose on specified days.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Cohort 1: TLN-254 Single AgentExperimental treatment 1 intervention
Group B: Cohort 2: TLN-254 Single AgentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of Participants With Objective Response
Time frame
Up to 2 years2
Percentage of Participants With CR
Time frame
Up to 2 years3
Percentage of Participants With PR
Time frame
Up to 2 yearsSecondary outcomes
1
Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time frame
Up to 2 years2
Number of Participants With Severity of TEAEs Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0
Time frame
Up to 2 years3
Plasma concentrations of TLN-254
Time frame
Day 1 of Cycle 1 and Day 1 of each even numbered Cycle for up to 2 years (Each Cycle length =28 days)4
Duration of Response (DOR)
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov