GLORY: Glofit-GemOx With Liso-Cel For Lymphoma
This study is testing a new treatment approach for large B-cell lymphomas that have come back or not responded to previous treatments (relapsed/refractory large B-cell lymphomas). It combines several medications: obinutuzumab, glofitamab, gemcitabine, oxaliplatin, and lisocabtagene maraleucel (liso-cel). The goal is to see how well this combination works and if it is safe. You might be able to join if you are 18 or older and have a confirmed diagnosis of large B-cell non-Hodgkin lymphoma, including specific types like diffuse large B-cell lymphoma. The main way we'll know if the treatment is successful is by looking at the complete response rate (CRR) to lisocabtagene maraleucel. The current status of this study is unclear, and it plans to enroll 56 participants.
- Study design
- This is a single-arm study, meaning all participants receive the same treatment. It plans to enroll 56 participants.
- What's involved
- You would receive intravenous infusions of obinutuzumab, glofitamab, gemcitabine, oxaliplatin, cyclophosphamide, and fludarabine. You would also undergo leukapheresis, a procedure to collect stem cells.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your complete response rate will be measured until you start another non-study anticancer therapy or for up to 2 years from the day the last participant is enrolled, whichever comes first.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07711483
GLORY: Glofit-GemOx With Liso-Cel For Lymphoma
Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatmentMassachusetts General HospitalInvestigator-initiated
~56 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:ObinutuzumabGlofitamabGemcitabine & oxaliplatinLeukapheresisLymphodepleting chemotherapyLISOCABTAGENE MARALEUCEL
At a glance
Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete Response Rate (CRR) to lisocabtagene maraleucel
Measured over 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.
Conditions
NCT07711483
Where you'd take part
This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Beth Israel Deaconess Medical Center
Boston, Massachusettsstudy coordinator listed
Massachusetts General Hospital
Boston, Massachusettsstudy coordinator listed
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Jeremy Abramson, MD, MMSc · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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.
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.
Exclusion
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
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.
What this trial measures
- Complete Response Rate (CRR) to lisocabtagene maraleucelScreening 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.
The complete response rate (CRR) is defined as the proportion of subjects achieving an objective response of complete response prior to start of another non-study anticancer therapy. CRR is based on the best overall response post-lisocabtagene maraleucel infusion. CRR will be defined according to the Lugano Classification.