GLORY: Glofit-GemOx With Liso-Cel For Lymphoma

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• Histologically confirmed large B-cell NHL including diffuse large B-cell lymphoma (DLBCL), either de novo or transformed from any indolent B-cell lymphoma, DLBCL NOS, primary mediastinal [thymic] large B-cell lymphoma (PMBCL), high grade B-cell lymphoma NOS, or high grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements [double/triple-hit lymphoma (DHL/THL)]; and grade 3B follicular lymphoma.
• Relapsed or refractory to 1 prior line of systemic lymphoma therapy if relapse/refractory within 12 months of initial treatment. Previous therapy must have included a CD20-targeted agent and an anthracycline or alkylating agent. Patients may have received steroids and/or polatuzumab-rituximab (without bendamustine), and/or radiation therapy for disease control and/or palliation "holding therapy" between frontline therapy and protocol registration and this will not be considered an additional line of systemic therapy.
• OR Relapsed or refractory to 1 prior line of systemic lymphoma therapy at any time after initial treatment if patient is ineligible for a stem cell transplant. Previous therapy must have included a CD20-targeted agent and an anthracycline or alkylating agent. Patients may have received steroids and/or polatuzumab-rituximab (without bendamustine), and/or radiation therapy for disease control and/or palliation "holding therapy" between frontline therapy and protocol registration and this will not be considered an additional line of systemic therapy.
• Intent and eligibility to proceed to therapy with lisocabtagene maraleucel
• Adult patients ≥ 18 years
• PET-positive measurable disease per Lugano criteria
• ECOG performance status 0-2
• Estimated creatinine clearance of ≥30 mL/min, calculated using the Cockcroft and Gault equation (if male: [140 - Age] x Mass [kg] / [72 x creatinine g/dL]; multiply by 0.85 if female)
• Serum Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤ 3 times the ULN
• Total Bilirubin ≤1.5 x ULN, unless directly attributable to Gilbert-Meulengracht syndrome and ≤3.0 mg/dL
• Absolute neutrophil count (ANC) ≥ 1000/mm3 (G-CSF support allowed if ≥ 24 hours prior to screening lab draw)
• Hemoglobin ≥8g/dL
• Platelets ≥ 50,000/mm3 without transfusion within 7 days
• Patients with primary CNS lymphoma are not eligible. Patients with secondary CNS involvement by lymphoma are eligible if they otherwise meet all eligibility criteria.
• The effects of glofitamab, gemcitabine, and oxaliplatin on the developing human fetus are unknown. For this reason and because immunotherapy/chemotherapy agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate double-method (each partner) contraception (acceptable means of birth control: condoms (male), condoms (female), intrauterine devices, contraceptive implants, combined hormonal contraceptives (pills, patches, vaginal rings), progestin-only pills, depot medroxyprogesterone acetate (DMPA) injections; abstinence) prior to study entry and for the duration of study participation. 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. Men and women treated or enrolled on this protocol must also agree to use adequate contraception for the duration of study participation, and 12 months after completion of lisocabtagene maraleucel administration.
• Willing and able to participate in all required evaluations and procedures in this study protocol.
• Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information.
• Ability to understand and agree to forgo donation of blood, organs, sperm, semen, or egg cells after treatment with liso-cel for 12 months.

You cannot join if

• History of prior malignancy that could affect compliance with the protocol or interpretation of results, except for the following: Non-melanoma skin cancers, in situ malignancies, prostate cancer followed with watchful waiting, indolent lymphoma, any previously treated malignancy felt at low risk for recurrence.
• Evidence of disease (such as severe or uncontrolled systemic diseases) that, in the investigator's opinion, make it undesirable for the patient to participate in the study or that would jeopardize compliance with the protocol
• Treatment with prior CAR T-cell therapy.
• Treatment with prior CD20:CD3 bispecific antibody therapy.
• History of or ongoing confirmed progressive multifocal leukoencephalopathy (PML)
• Received any investigational drug within 30 days or 5 half-lives (whichever is shorter) before first dose of study drug.
• Received a live virus vaccination within 28 days of first dose of study drug.
• Concurrent participation in another therapeutic clinical trial.
• Current life-threatening illness, medical condition, or organ system dysfunction which, in the Investigator's opinion, could compromise the subject's safety or put the study at risk
• Previous treatment with gene therapy product or adoptive T cell therapy
• Allogeneic stem cell transplant within 90 days of leukapheresis
• Active acute or chronic GVHD requiring immunosuppressive therapy within 6 weeks prior to enrollment
• Grade 2 or higher peripheral neuropathy
• HIV infection with positive viral titer by PCR. HIV with negative viral titer by PCR is not an exclusion as long as CD4 count is ≥200 and patient is taking combination antiretroviral therapy.
• Serologic status reflecting active hepatitis B or C infection
• Subjects who are hepatitis B core antibody (HBcAb) positive and who are hepatitis B surface antigen (HBsAg) negative will need to have a negative PCR result before enrollment and must be willing to undergo DNA PCR testing during the study and take anti-HBV therapy with entecavir or equivalent. Those who are HBsAg-positive or hepatitis B PCR positive will be excluded.
• Subjects who are hepatitis C antibody positive will need to have a negative PCR result before enrollment. Those who are hepatitis C PCR positive will be excluded.
• Any active significant infection (e.g., bacterial, viral, or fungal, including subjects with positive cytomegalovirus [CMV] DNA polymerase chain reaction [PCR])
• Clinically relevant CNS pathology
• Autoimmune disease requiring chronic systemic corticosteroids at a dose of greater than 10 mg of prednisone daily or an equivalent dose of another corticosteroid
• Treatment with alemtuzumab, fludarabine, and/or bendamustine within 6 months leukapheresis or cladribine within 3 months of leukapheresis
• Known history of hypersensitivity or anaphylaxis to study drug(s) including active product or excipient components.
• Breastfeeding or pregnant: Pregnant women are excluded from this study because glofitamab, gemcitabine, oxaliplatin, fludarabine, and cyclophosphamide are agents with the potential for teratogenic or abortifacient effects. Breastfeeding should be discontinued for at least 12 months after last exposure if the mother is treated with these agents.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

Treatments listed in the registry

• Obinutuzumab (Drug): Intravenous infusion received once, 5 days prior to receiving the first doses of glotfitamab, gemcitabine, and oxaliplatin.
• Glofitamab (Drug): Intravenous infusion received on days 1, 3, 8, and 15 of cycle 1 and on day 15 of the optional cycle 2 (each cycle is 21 days).
• Gemcitabine & oxaliplatin (Drug): Intravenous infusions received on day 1 of cycle 1 and an optional cycle 2 (each cycle is 21 days).
• Leukapheresis (Procedure): Procedure to collect stem cells for modification that will occur 2 days prior to administration of the first doses of glofitamab, gemcitabine, and oxaliplatin.
• Lymphodepleting chemotherapy (Drug): Intravenous infusions of cyclophosphamide and fludarabine administered for 3 consecutive days 3-5 days prior to receive lisocabtagene maraleucel.
• LISOCABTAGENE MARALEUCEL (Drug): Intravenous infusion of participant's re-manufactured stem cells administered one 3-5 days after completing lymphodepleting chemotherapy.

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• leukapheresis: Part of the study plan

Main goals

• Complete Response Rate (CRR) to lisocabtagene maraleucel (Screening to start of another non-study anticancer therapy or for up to 2 years from the day the last participant is enrolled, whichever occurs first.)

Other goals

• Overall Response Rate to Glofit-GemOx bridging
• Progression-Free Survival (PFS) after lisocabtagene maraleucel
• Overall Survival (OS) after lisocabtagene maraleucel
• Overall Response Rate (ORR) to lisocabtagene maraleucel
• Duration of Response (DOR) after lisocabtagene maraleucel
• Incidence of Treatment-Emergent Adverse Events from Glofit-GemOx to 90 days post-lisocabtagene maraleucel
• Proportion of Participants Receiving Interventions for CRS or Neurotoxicity
• Incidence of Cytokine Release Syndrome (CRS)
• Incidence of Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
• Incidence of Grade ≥3 Cytokine Release Syndrome (CRS)
• Incidence of Grade ≥3 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS)
• Incidence and Grading of Infection
• Incidence and Grading of Cytopenias
• Incidence and Number of Transfusions

Planned enrollment: 56 (estimated).

• Massachusetts General Hospital, Boston, Massachusetts

Site status as of Oct 30, 2026. Check the live record before contacting a site.

• ClinicalTrials.gov NCT07711483

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Oct 21, 2026. Public record; not medical advice.