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Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma

Phase Ib Trial of Tegavivint in Patients With Relapsed/Refractory C-MYC Overexpressing Large B-Cell Lymphoma

NCT05755087•Lapo Alinari

Summary

This phase I trial tests the safety, side effects, and best dose of tegavivint in treating patients with large b-cell lymphomas that has come back (relapsed) or does not respond to treatment (refractory). Tegavivint may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving tegavivint may help control the disease.

Detailed Description

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of tegavivint in patients with relapsed/refractory c-Myc overexpressing large B-cell lymphoma. II. To determine the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) of tegavivint. SECONDARY OBJECTIVES: I. To determine the preliminary efficacy of tegavivint in patients with relapsed/refractory c-Myc overexpressing large B-cell lymphoma. II. To determine the pharmacokinetic parameters of tegavivint. EXPLORATORY OBJECTIVES: I. To correlate response to tegavivint with the presence of MYC, FBW7 and SKP2 mutations. II. To correlate response to tegavivint with TBL1 and c-Myc expression assessed by standard IHC on archived tumor biopsy. III. To determine the effects of tegavivint on immune cell subsets viability and function. OUTLINE: This is a dose-escalation study of tegavivint. Patients receive tegavivint intravenously (IV) on study. Patients also undergo computed tomography (CT) and/or positron emission tomography (PET) and undergo blood sample collection throughout the trial.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•One of the following three conditions:
•Relapsed/refractory histologically confirmed germinal center B-cell-like (GCB) and non-GCB diffuse large B cell lymphoma (DLBCL) with the following features:
•* Increased expression of MYC (\>= 40%) and BCL2 (\>= 50%) by immunohistochemistry (IHC) or
•* Presence of isolated MYC translocation Or
•Relapsed/refractory histologically confirmed high-grade B-cell lymphoma (HGBCL) (double hit \[DH\] and triple hit \[TH\]) with translocations of MYC and BCL2 and/or BCL6 Or
•Histologic transformation of indolent non-Hodgkin's lymphoma (NHL) to DLBCL
•* Presence of BCL2 translocation with increased expression of MYC (≥40%) with or without MYC translocation
•Patients must have had at least two prior systemic therapies
•Patients must be ineligible for or refused autologous or allogenic hematopoietic stem cell transplantation or chimeric antigen receptor (CAR) T-cell therapy. Prior autologous stem cell transplant and/or CAR-T are allowed, if received \>= 3 months prior to enrollment
•Age \>= 18 years
+15 more criteria

Exclusion Criteria

•History of allergic reactions attributed to compounds of similar chemical or biologic composition to tegavivint or other agents used in study
•Known active central nervous system (CNS) lymphoma, history of CNS involvement allowed if in remission for \>= 3 months
•Evidence of chronic active Hepatitis B, chronic active Hepatitis C infection
•Human immunodeficiency virus (HIV)-positive patients on combination antiretroviral therapy (e.g., strong CYP3A inhibitors and/or concomitant medications that are excluded) are ineligible because of the potential for pharmacokinetic interactions with tegavivint
•Known history of active TB (Bacillus Tuberculosis)
•Major surgery within 3 weeks prior to start of study treatment
•Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality or corrected QT interval (QTc) \> 480 msec
•Uncontrolled concurrent illness including, but not limited to: ongoing or active infection (Viral, bacterial, fungal or other)
•Psychiatric illness/social situations that would limit compliance with study requirements
•Pregnant and breastfeeding women are excluded from this study. The effects of tegavivint on the developing human fetus have the potential for teratogenic or abortifacient effects. There is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with tegavivint
+6 more criteria

Locations (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Key Dates

Start Date

March 6, 2023

Primary Completion Date

March 5, 2028

Completion Date

March 5, 2028

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell TypeRecurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell TypeRecurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRecurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 RearrangementsRefractory Diffuse Large B-Cell Lymphoma Activated B-Cell TypeRefractory Diffuse Large B-Cell Lymphoma Germinal Center B-Cell TypeRefractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 RearrangementsRefractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 RearrangementsTransformed Indolent B-Cell Non-Hodgkin Lymphoma to Diffuse Large B-Cell Lymphoma

Interventions

Biospecimen Collection

PROCEDURE

Computed Tomography

PROCEDURE

Positron Emission Tomography

PROCEDURE

Tegavivint

DRUG

Bone Marrow Biopsy

PROCEDURE

Bone Marrow Aspiration

PROCEDURE

Contacts

The Ohio State Comprehensive Cancer Center

CONTACT

800-293-5066 OSUCCCClinicaltrials@osumc.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Tegavivint for Treating Patients With Relapsed or Refractory Large B-Cell Lymphoma

Inclusion Criteria

Exclusion Criteria

TTI-622 in Combination With Pembrolizumab for the Treatment of Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Loncastuximab Tesirine in Combination With Chemotherapy Prior to Stem Cell Transplant for the Treatment of Recurrent or Refractory Diffuse Large B-Cell Lymphoma

Alisertib and Romidepsin in Treating Patients With Relapsed or Refractory B-Cell or T-Cell Lymphomas