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Relapsed/Refractory Diffuse Large B-cell LymphomaPhase 2NCT07748364

Glofitamab in B-NHL Using Mid-Therapy Intratumoral Transcriptomics

A Phase 2 study testing Glofitamab in people with Relapsed/Refractory Diffuse Large B-cell Lymphoma and Relapsed/Refractory Mantle Cell Lymphoma, run by Joshua Brody at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This trial will enroll patients with relapsed/refractory DLBCL and MCL, with the opportunity to receive single-agent glofitamab as early as the second-line. Patients will have superficially accessible disease to enable core-needle biopsy prior to therapy initiation, and on cycle 1 day 15 and cycle 2 day 1 of therapy… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Glofitamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
Sep 2026to Jul 2027
Phase
Phase 2
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

  • Patients with pathologically confirmed diagnosis of aggressive CD20(+) B-NHL,
  • including DLBCL and MCL.
  • Stage II, III or IV by Ann Arbor Classification.
  • Superficially accessible lesion for core-needle biopsy, e.g. cervical, axillary,
  • inguinal, subcutaneous.
  • Disease that has progressed (clinically or radiographically) after standard-of-care
  • prior therapy, including anthracycline-based therapy for DLBCL and anti-CD20
  • mAb-based therapy for all histologies.

Who cannot join

  • Patients who meet any of the following criteria will be excluded from study entry:
  • Contraindication to any of the individual components of glofitamab or history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
  • Any prior treatment with a BsAb targeting CD3 and CD20
  • Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation
  • Prior treatment with systemic immunotherapeutic agents, including but not limited to, radio-immuno-conjugates, antibody-drug conjugates, immune/cytokines and monoclonal antibodies (mAbs) (e.g., anti-cytotoxic T lymphocyte associated protein 4, anti-PD-1, and anti-PD-L1) within 4 weeks or five half-lives of the drug, whichever is shorter
  • Treatment with CAR-T therapy within 30 days prior to first dose of glofitamab
Show all 47Show fewer
  • Any investigational therapy for the purposes of treating cancer within 28 days prior to the start of Cycle 1
  • Prior radiotherapy to the mediastinal/pericardial region Radiotherapy to non-target lesion sites will be permitted.
  • Corticosteroid use >50 mg/day of prednisone or equivalent, for purposes other than lymphoma symptom control
  • Participants receiving corticosteroid treatment with >50 mg/day of prednisone or equivalent for reasons other than lymphoma symptom control (e.g., rheumatoid arthritis) must be documented to be on a stable dose of at least 4 weeks duration prior to the start of Cycle 1.
  • Corticosteroid therapy for control of cancer symptoms or side effects of prior treatment (e.g., nausea or B-symptoms) is permitted.
  • The use of inhaled corticosteroids is permitted.
  • The use of mineralocorticoids for management of orthostatic hypotension is permitted.
  • The use of physiologic doses of corticosteroids for management of adrenal insufficiency is permitted.
  • Participants who require lymphoma symptom control during screening may receive steroids in the following manner:
  • Up to 50 mg/day of prednisone or equivalent may be used for lymphoma symptom control during screening, including prior to finalization of staging (not included as part of pre-phase treatment).
  • If glucocorticoid treatment is urgently required at higher doses for lymphoma symptom control prior to the start of study treatment, tumor assessments must be completed prior to initiation of 50-100 mg/day of prednisone or equivalent. Prednisone 50-100 mg/day or equivalent may be given for a maximum of 10-14 days as a pre-phase treatment. As part of the pre-phase treatment, vincristine may not be administered.
  • History of other malignancy that could affect compliance with the protocol or interpretation of results:
  • Participants with a history of curatively treated basal or squamous cell carcinoma or melanoma of the skin or in situ carcinoma of the cervix at any time prior to the study are eligible.
  • Participants with any malignancy appropriately treated with curative intent and the malignancy has been in remission without treatment for > 2 years prior to enrollment are eligible.
  • Participants with low-grade, early-stage prostate cancer (Gleason score 6 or below, Stage 1 or 2) with no requirement for therapy at any time prior to study are eligible.
  • Significant or extensive history of cardiovascular disease such as New York Heart Association Class III or IV cardiac disease or Objective Assessment Class C or D, myocardial infarction within the last 3 months prior to the start of Cycle 1, unstable arrhythmias, or unstable angina
  • Recent major surgery (within 4 weeks prior to the start of Cycle 1), other than for diagnosis
  • Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease Participants with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurological deficits, as judged by the investigator, are allowed.
  • Current or past history of CNS lymphoma
  • Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
  • Current or past history of Waldenström macroglobulinemia
  • History or presence of an abnormal ECG that is clinically significant in the investigator's opinion
  • Patients with known or suspected active infection, or reactivation of a latent infection, whether bacterial, viral (including, but not limited to, SARS-Cov-2, Epstein-Barr virus (EBV), cytomegalovirus (CMV), hepatitis B, and hepatitis C), fungal, mycobacterial, or other pathogens (excluding fungal infections of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics (for IV antibiotics this pertains to completion of last course of antibiotic treatment) within 4 weeks of dosing
  • History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents, as follows:
  • Grade 3 or higher adverse events with the exception of Grade 3 endocrinopathy managed with replacement therapy.
  • Grade 1-2 adverse events that did not resolve to baseline after treatment discontinuation.
  • Clinically significant liver disease, including active viral or other hepatitis or cirrhosis
  • Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
  • Any of the following abnormal laboratory values (unless any of these abnormalities are due to underlying lymphoma):
  • INR or PT > 1.5 x upper limit of normal (ULN) in the absence of therapeutic anticoagulation.
  • PTT or aPTT >1.5 x ULN in the absence of a lupus anticoagulant.
  • Serum AST and ALT >2.5 x ULN.
  • Total bilirubin >1.5 x ULN. Participants with documented Gilbert disease may be enrolled if total bilirubin is > 3.0 x ULN.
  • Live, attenuated vaccine within 4 weeks before study treatment infusion on Day 1 of Cycle 1 or anticipation that such a live, attenuated vaccine will be required during the study. Live vaccines during the study and until participants B cells recover, are prohibited Influenza vaccination should be given during influenza season only. Participants must not receive live, attenuated influenza vaccine at any time during the study treatment period.
  • Suspected active or latent tuberculosis (as confirmed by a positive interferon-gamma release assay)
  • Positive test results for chronic hepatitis B infection (defined as positive hepatitis B surface antigen [HBsAg] serology) Participants with occult or prior hepatitis B infection (defined as positive total hepatitis B core antibody and negative HBsAg) may be included if hepatitis B virus (HBV) DNA is undetectable at the time of screening. Such participants must be willing to undergo HBV DNA testing on Day 1 of every cycle and every 3 months for at least 12 months after the final cycle of study treatment and appropriate antiviral therapy as indicated.
  • Positive test results for hepatitis C (hepatitis C virus [HCV] antibody serology testing) Participants positive for HCV antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV RNA.
  • Positive test results for HTLV-1
  • Participants with a history of progressive multifocal leukoencephalopathy
  • Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 18 months after pretreatment with obinutuzumab or 2 months after the final dose of glofitamab, whichever is longer
  • Positive SARS-CoV-2 test within 7 days prior to enrollment. Rapid antigen test result is also acceptable.

Trial locations and contacts

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

Martine Van Voorthuysen contact

(646) 745-6092

Martine.VanVoorthuysen@mssm.edu

United States1 site

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

Other trials in United States

About this study

Official title: Phase II Trial of Glofitamab in B-NHL Using Mid-Therapy Intratumoral Transcriptomics

This trial will enroll patients with relapsed/refractory DLBCL and MCL, with the opportunity to receive single-agent glofitamab as early as the second-line. Patients will have superficially accessible disease to enable core-needle biopsy prior to therapy initiation, and on cycle 1 day 15 and cycle 2 day 1 of therapy administration to enable high throughput molecular profiling of disease and immune dynamics while on treatment.

Read the detailed description

This trial will enable patients with relapsed/refractory disease to receive glofitamab at an earlier line than is currently approved in the United States. Overall, it is anticipated that the benefits of glofitamab as a single agent will outweigh its potential risks, particularly given the poor prognosis of patients with relapsed/refractory DLBCL or MCL who have failed SoC regimens. Glofitamab offers high rates of complete response with durable disease control and favorable toxicity profile relative to current SoC regimens, such as chemotherapy or autologous stem cell transplantation.

Being tested
Glofitamab
Keywords
DLBCL (diffuse large B-cell lymphoma), MCL (mantle cell lymphoma), relapsed, refractory, GLOFITAMAB, TRANSCRIPTOMICS
Medical subject headings
Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell, Dendritic Cell Sarcoma, Interdigitating, Recurrence

What participants receive

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

  • GlofitamabBiological

    Also called Columvi®

    Glofitamab is a bispecific T-cell-engaging antibody, designed to bind CD20 on B-cells, and CD3 on T-cells, bringing T-cells into close contact with malignant B-cells to trigger immune-mediated killing.

Study groups in NCT07748364
Study groupRoleWhat they receive
Participants with relapsed/refractory DLBCL or MCLExperimentalParticipants will receive step-up dosing of IV infusion of glofitamab on cycle 1 day 8 (2.5 mg) and cycle 1 day 15 (10 mg), followed by full dose (30 mg) starting on cycle 2 (C2) day 1 (day 22 overall) and then days 1±3 of all subsequent 21 day cycles.
Receives: Biological: Glofitamab

What is being measured

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

  1. Proportion of patients with an increase of CD20(-) tumor cells >= 10 fold

    Proportion of patients with an increase of CD20(-) tumor cells >= 10-fold increase in proportion of CD20(-) lymphoma cells within 3 weeks of initiation of glofitamab therapy.

    Measured: within 3 weeks of glofitamab therapy initiation

Secondary outcomes (1)

  1. Transcriptional changes in tumor cells

    Transcriptional changes in tumor cells within 3 weeks of initiation of glofitamab therapy, defined as the fold-change of individual gene RNA transcript counts between timepoints.

    Measured: within 3 weeks of glofitamab therapy initiation

Timeline

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

  1. First posted5 Aug 2026
  2. Study startSep 2026 (estimated)
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a Phase II single-center, open-label trial of monotherapy with glofitamab, a CD3xCD20 bispecific antibody (BsAb), in patients with relapsed or refractory DLBCL and MCL. This study will enroll 16 patients with disease accessible for core needle biopsy with aggressive B-NHL (8 DLBCL and 8 MCL) with glofitamab. Core needle biopsies will be obtained prior to treatment and on cycle 1 day 15 and cycle 2 day 1 (day 22 overall) of treatment. All patients who undergo biopsy before treatment initiation and at least one biopsy during treatment will be considered for further analysis.. Patients who achieve CR prior to on treatment biopsy or patients without at least one biopsy on treatment will not be evaluable for the primary endpoint. The trial will allow for up to 1 patient to be replaced.
Masking
None (open label)
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07748364
Sponsor's protocol ID
PRMC-26-023
Status last verified
Jul 2026
First submitted
31 Jul 2026
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: Given the complexity and exploratory nature of exploratory biomarker analyses, data derived from these analyses will generally not be provided to study investigators or patients unless required by law. The aggregate results of any conducted research will be available in accordance with the effective Investigator policy on study data publication.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Glofitamab in people with Relapsed/Refractory Diffuse Large B-cell Lymphoma and Relapsed/Refractory Mantle Cell Lymphoma, run by Joshua Brody 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 8 inclusion and 47 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: opening soon, as of the sponsor's last update on 5 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Martine Van Voorthuysen ((646) 745-6092, Martine.VanVoorthuysen@mssm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients with an increase of CD20(-) tumor cells >= 10 fold (time frame: within 3 weeks of glofitamab therapy initiation). 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 NCT07748364.

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 5 Aug 2026.

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