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Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell TypePhase 1NCT05755087

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

A Phase 1 study testing Biospecimen Collection, Computed Tomography and Positron Emission Tomography in people with Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type and Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type, run by Lapo Alinari at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Computed Tomography and Positron Emission Tomography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
6 Mar 2023to 5 Mar 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
  • Patients must have radiographically measurable disease by standard positron emission tomography (PET) uptake with at least one site of measured disease by standardized uptake value (SUV)
  • Absolute neutrophil count (ANC) ≥ 500/mcL
  • Platelet count ≥ 25,000/mcL
  • Total bilirubin =< 1.5 x the upper limit of the normal range (ULN)
  • Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3 x institutional ULN
  • Creatinine clearance >= 60 ml/min by Cockcroft-Gault (actual body weight will be used to estimate creatinine clearance)
  • Patients must be willing and able to understand and give written informed consent and comply with all study related procedures
  • Women of child-bearing potential (WOCBP) and men who are sexually active with WOCBP must agree to use one hormonal contraceptive (e.g. combined oral contraceptives, patch, vaginal ring, injectables, and implants); intrauterine device (IUD) or intrauterine system (IUS); vasectomy or tubal ligation; and one effective method of contraception, including male condom, female condom, cervical cap, diaphragm or contraceptive sponge or abstain from sex for the duration of study participation and for 4 months following completion of tegavivint administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
  • Contraception includes:
  • Total abstinence (when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
  • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy or tubal ligation at least 6 weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment
  • Male sterilization (at least 6 months prior to screening). For female patients on the study the vasectomized male partner should be the sole partner for that patient
  • Use of oral (estrogen and progesterone), injected or implanted combined hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS) or other forms of hormonal contraception that have comparable efficacy (failure rate <1%), for example hormone vaginal ring or transdermal hormone contraception
  • Sexually active males must use a condom during intercourse while taking drug and for 4 months after stopping study treatment and should not father a child in this period. A condom is required to be used also by vasectomized men in order to prevent delivery of the drug via seminal fluid In case of use of oral contraception women should have been stable on the same pill for a minimum of 3 months before taking study treatment. Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least 6 weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential

Who cannot join

  • 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
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  • 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
  • Patients with abnormal serum chemistry values other than the specific limits detailed above, that in the opinion of the investigator is considered to be clinically significant, should be discussed with the Study PI before being enrolled in the study
  • Personal history of malignancy except:
  • Cervical intraepithelial neoplasia;
  • Skin basal cell carcinoma;
  • Treated localized prostate carcinoma with prostate specific antigen (PSA) <1 ng/mL or untreated indolent prostate cancer
  • Neoplasia treated with curative intent, in remission for at least three years and considered at low risk of relapse

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

The Ohio State Comprehensive Cancer Center contact

800-293-5066

OSUCCCClinicaltrials@osumc.edu

United States1 site, 1 recruiting

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210

    Lapo Alinari, MD, PhD, 614-293-5594, Lapo.Alinari@osumc.edu

    Lapo Alinari, MD, PhD

    Recruiting

Other trials in United States

About this study

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

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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:

  1. 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.

Being tested
Biospecimen Collection, Computed Tomography, Positron Emission Tomography, Tegavivint, Bone Marrow Biopsy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo blood sample collection

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Positron Emission TomographyProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan

    Undergo PET scan

  • TegavivintDrug

    Also called BC 2059, BC-2059, BC2059, Tegatrabetan

    Given IV

  • Bone Marrow BiopsyProcedure or surgery

    Also called Biopsy of bone marrow, Biopsy, Bone marrow

    Undergo bone marrow biopsy and aspiration

  • Bone Marrow AspirationProcedure or surgery

    Undergo bone marrow biopsy and aspiration

Study groups in NCT05755087
Study groupRoleWhat they receive
Treatment (Tegavivint)ExperimentalPatients receive tegavivint IV over 4 hours on days 1, 8, 15, and 22 of each cycle. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients also undergo CT and/or PET and undergo blood sample collection throughout the trial. Patients may also undergo bone marrow biopsy and aspirate during screening and on the trial.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Procedure: Positron Emission Tomography; Drug: Tegavivint; Procedure: Bone Marrow Biopsy; Procedure: Bone Marrow Aspiration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of dose-limiting toxicity

    1. To be declared as dose-limiting toxicity, an adverse event must be related (definite, probable, or possible) to study treatment during the first cycle of therapy only (first 28 days). Any death at least possibly related to tegavivint will be a DLT. No DLTs observed thus far.

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  2. Maximum tolerated dose (MTD) for tegavivint

    Determination of the MTD of tegavivint using a 3+3 design.

    Measured: At the end of Cycle 1 (each cycle is 28 days)

  3. Determination of the recommended phase II dose (RP2D) of tegavivint

    1. This study uses a traditional "3+3" designs. We therefore anticipate a total sample size of 12 with the maximum expected sample size of 24. Primary endpoint not yet reached.

    Measured: At the end of Cycle 1 (each cycle is 28 days)

Secondary outcomes (6)

  1. Overall response rate (ORR)

    Will be estimated by molecular subtype and across subtypes with exact 80% and 90% confidence intervals.

    Measured: After cycle 2 (each cycle is 28 days) or end of treatment

  2. Complete response (CR) rate

    Will be estimated by molecular subtype and across subtypes with exact 80% and 90% confidence intervals.

    Measured: At the end of Cycle 2 (each cycle is 28 days)

  3. Duration of response (DOR)

    Will be summarized by the Kaplan-Meier method, and two-year estimates will be provided with 80% and 90% confidence intervals, for each subtype and for all patients.

    Measured: Time from the date of first response until the first date of progression or death from any cause, assessed up to 2 years from study enrollment

  4. Progression-free survival (PFS)

    Will be summarized by the Kaplan-Meier method, and two-year estimates will be provided with 80% and 90% confidence intervals, for each subtype and for all patients.

    Measured: Time from the date of first treatment until the first date of progression or death from any cause, assessed up to 2 years from study enrollment

  5. Event-free survival (EFS)

    Will be summarized by the Kaplan-Meier method, and two-year estimates will be provided with 80% and 90% confidence intervals, for each subtype and for all patients.

    Measured: Time from the date of first treatment until the first date of progression, re-treatment of lymphoma after initial immune-therapy, or death from any cause, assessed up to 2 years from study enrollment

  6. Overall survival (OS)

    Will be summarized by the Kaplan-Meier method, and two-year estimates will be provided with 80% and 90% confidence intervals, for each subtype and for all patients.

    Measured: Time from the date of first treatment until the date of death from any cause, assessed up to 2 years from study enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2023
  2. Study start6 Mar 2023
  3. Primary completion5 Mar 2028 (estimated)
  4. Study completion5 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05755087
Sponsor's protocol ID
OSU-21359
Other IDs
NCI-2023-00200
Status last verified
Feb 2026
First submitted
1 Feb 2023
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Biospecimen Collection, Computed Tomography and Positron Emission Tomography in people with Recurrent Diffuse Large B-Cell Lymphoma Activated B-Cell Type and Recurrent Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type, run by Lapo Alinari at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact The Ohio State Comprehensive Cancer Center (800-293-5066, OSUCCCClinicaltrials@osumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose-limiting toxicity (time frame: At the end of Cycle 1 (each cycle is 28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05755087.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

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