TLN-121 in Relapsed or Refractory Non-Hodgkin Lymphomas
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 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must have measurable disease at study entry
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.
Nodal T-follicular helper (Tfh) cell lymphoma angioimmunoblastic; Follicular helper T-cell lymphoma, angioimmunoblastic type (AITL).
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
TLN-121
DrugSpecified dose on specified days.
zeprumetostat (TLN-254)
DrugSpecified dose on specified days.
TLN-121
DrugSpecified dose on specified days.
Treatment groups
180 Participants
are divided into 2 treatment groupsGroup A: Single AgentExperimental treatment 1 intervention
Group B: Combination TreatmentExperimental treatment 2 interventions
Trial outcomes
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 years2
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs)
Time frame
Up to 2 years3
Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
Time frame
Up to 2 years4
Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0
Time frame
Up to 2 yearsSecondary outcomes
1
Maximum Observed Plasma Concentration (Cmax) of TLN-121
Time frame
Up to 2 years2
Time to Maximum Plasma Concentration (Tmax) of TLN-121
Time frame
Up to 2 years3
Minimum Observed Plasma Concentration (Cmin) of TLN-121
Time frame
Up to 2 years4
Area Under the Plasma Concentration-Time Curve (AUC) of TLN-121
Time frame
Up to 2 yearsSponsors and contacts
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Source ClinicalTrials.gov