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New combo therapy aims to boost remission in Hard-to-Treat lymphoma
NCT ID NCT07711483
First seen Jul 17, 2026 · Last updated Jul 17, 2026
Summary
This phase 2 trial tests whether a combination of the targeted drug glofitamab with chemotherapy (gemcitabine and oxaliplatin) can improve the effectiveness of a CAR-T cell therapy called lisocabtagene maraleucel in people with relapsed or refractory aggressive B-cell lymphomas. Participants first receive the drug combination to shrink their cancer, then undergo CAR-T cell infusion. The study measures how many patients achieve complete remission and how long the effects last.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a combination of glofitamab, gemcitabine, oxaliplatin, and lisocabtagene maraleucel (a CAR-T cell therapy)
- What this could lead to
- If successful, this approach could improve the chance of complete remission for people with hard-to-treat B-cell lymphomas who have not responded to standard treatments.
- What could go wrong
- This is a phase 2 trial with a small number of participants, so results may not apply to everyone. The combination therapy carries risks of serious side effects, including immune reactions and infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 56 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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 1. 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. 2. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
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Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- A simple blood draw might reveal hidden eye lymphoma
- Can a new drug combo revive immunotherapy for lymphoma?
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