Glofitamab in B-NHL Using Mid-Therapy Intratumoral Transcriptomics

Starting soon · Phase 2

Conditions studied: Relapsed/Refractory Diffuse Large B-cell Lymphoma, Relapsed/Refractory Mantle Cell Lymphoma

In brief

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.

Key facts

Study ID

NCT07748364

Run by

Joshua Brody

People needed

16

Starts

2026-09-01

Expected to finish

2027-07-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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