zeprumetostat (TLN-254): Specified dose on specified days.
TLN-121: Specified dose on specified days.
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
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
Disease Characteristics
1. Participant must have measurable disease at study entry
2. Participants must have one of the following histologically documented hematologic malignancies:
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 prior lines of therapy.
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 relapsed 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. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
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 autologous 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.
Primary outcome measure(s)
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. — Up to 2 years
Incidence and Severity of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Related Adverse Events (TRAEs) — Up to 2 years
Clinically significant ECG QT Interval from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0 — Up to 2 years
Clinically significant laboratory abnormalities from baseline in safety laboratory test results, assessed as per NCI CTCAE v5.0 — Up to 2 years
Trial sites (14)
Facility
City
Region
Status
Stanford Medicine Cancer Center
Palo Alto
California
Recruiting
The START Center for Cancer Care - Midwest
Grand Rapids
Michigan
Recruiting
Washington University School of Medicine
St Louis
Missouri
Recruiting
Memorial Sloan Kettering Cancer Center
New York
New York
Recruiting
Weill Cornell Medicine - New York Presbyterian Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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