Testing Glofitamab for Mantle Cell Lymphoma After CAR-T Therapy
This study is testing a drug called glofitamab, given with obinutuzumab, for people with mantle cell lymphoma (a type of blood cancer) that has returned or didn't respond to previous treatment, specifically after CAR T-cell therapy. CAR T-cell therapy is a treatment where your own immune cells are changed to fight cancer. Glofitamab is an antibody that helps your immune system (specifically T-cells) find and kill lymphoma cells. The study aims to see how many patients respond to this treatment. You may be eligible if you are 18 or older and have mantle cell lymphoma that has come back or not responded after CAR T-cell therapy. The study is currently unclear on its recruitment status and plans to enroll about 20 participants.
- Study design
- This study is testing the safety and effectiveness of glofitamab and obinutuzumab in about 20 participants. It is an interventional study, meaning participants will receive a specific treatment.
- What's involved
- Participants will undergo blood sample collection and PET/CT scans. Glofitamab and obinutuzumab will be given intravenously (IV).
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure how well the treatment works for up to 2 years.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT07003295
Testing the Anti-cancer Drug, Glofitamab, in Patients With Mantle Cell Lymphoma (A Type of Blood Cancer) Whose Disease Returned After CAR-T Cell Therapy
Recruiting
PHASE2Ages 18+InterventionalTreatmentNational Cancer Institute (NCI)Government-funded
~20 participants
Updated 2026-09-09 on ClinicalTrials.gov
What's tested:Biospecimen CollectionComputed TomographyGlofitamabObinutuzumabPositron Emission Tomography
At a glance
Recruiting sites
11 of 11 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Objective response rate
Measured over Up to 2 years
Conditions
NCT07003295
Where you'd take part
This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Case Western Reserve University
Cleveland, Ohiostudy coordinator listed
Recruiting
City of Hope Comprehensive Cancer Center
Duarte, Californiastudy coordinator listed
Recruiting
Emory Saint Joseph's Hospital
Atlanta, Georgiastudy coordinator listed
Recruiting
Emory University Hospital Midtown
Atlanta, Georgiastudy coordinator listed
Recruiting
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgiastudy coordinator listed
Recruiting
Johns Hopkins University/Sidney Kimmel Cancer Center
Baltimore, Marylandstudy coordinator listed
Recruiting
Ohio State University Comprehensive Cancer Center
Columbus, Ohiostudy coordinator listed
Recruiting
University of Kentucky/Markey Cancer Center
Lexington, Kentuckystudy coordinator listed
Recruiting
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
- Cole H Sterling · PRINCIPAL_INVESTIGATOR · JHU Sidney Kimmel Comprehensive Cancer Center LAO
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
Patients must have histologically or cytologically confirmed diagnosis of mantle cell lymphoma that is relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen)
Patients must have been previously treated with an anti-CD19 CAR T-cell therapy and have failed or been intolerant to Bruton's tyrosine kinase (BTK) inhibition. Both commercial and investigational CAR-T products which target CD19 will be allowed, including dual-targeting products
Patients must have at least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan
Age ≥ 18 years. Because no dosing or adverse event (AE) data are currently available on the use of glofitamab and obinutuzumab in patients \< 18 years of age, children are excluded from this study
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 (Karnofsky ≥ 60%)
Absolute neutrophil count ≥ 1,000/mcL
Platelets ≥ 50,000/mcL
Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) or ≤ 3 x institutional ULN if the patient has Gilbert syndrome
Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 3 x institutional ULN
Creatinine ≤ 1.5 x institutional ULN OR glomerular filtration rate (GFR) ≥ 60 mL/min/1.73 m\^2
Patients with human immunodeficiency virus (HIV) infection are eligible if on effective anti-retroviral therapy with undetectable viral load within 6 months
Patients with a history of hepatitis B virus (HBV) infection or positive total hepatitis B core antibody (HBcAb) are eligible if the hepatitis B surface antigen (HBsAg) is negative and HBV DNA viral load is undetectable by polymerase chain reaction (PCR) at the time of screening. Such patients must be managed with appropriate anti-viral therapy, if indicated, and must be willing to undergo HBV DNA testing on day 1 of each cycle and every 3 months for at least 12 months after the final cycle of study treatment
Patients with a history of hepatitis C virus (HCV) infection or positive HCV antibody are eligible if HCV ribonucleic acid (RNA) viral load is undetectable by PCR
Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression and patients are asymptomatic from CNS involvement
Patients with new, progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that patients are asymptomatic and immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy
Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial, such as patients with prostate cancer or breast cancer receiving hormonal therapy
The effects of glofitamab and obinutuzumab on the developing human fetus are unknown. For this reason and because glofitamab and obinutuzumab are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; 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 treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 2 months after completion of glofitamab and 6 months after completion of obinutuzumab administration. Women of childbearing potential must use effective contraceptive precautions 2 months after completion of glofitamab treatment and 18 months after the last dose of obinutuzumab treatment
Ability to understand and the willingness to sign a written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants
Exclusion
Patients who have not recovered from AEs due to prior anti-cancer therapy (i.e., have residual toxicities \> grade 1) with the exception of alopecia
Patients who are receiving any other investigational agents
History of allergic reactions attributed to compounds of similar chemical or biologic composition to glofitamab and obinutuzumab
Pregnant women are excluded from this study because glofitamab and obinutuzumab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for AEs in nursing infants secondary to treatment of the mother with glofitamab and obinutuzumab, breastfeeding should be discontinued if the mother is treated with glofitamab and obinutuzumab
Patients with active CRS or requiring intervention for CRS within 14 days prior to study enrollment
Patients with active neurotoxicity or requiring intervention for neurotoxicity within 14 days prior to study enrollment
Patients requiring antimicrobial treatment or hospitalization for active infection within 14 days prior to study enrollment for known active bacterial, viral (including severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\]), fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds). Infection must be completely resolved prior to initiation of study treatment
Patients receiving systemic immunosuppressive medications within 14 days prior to study enrollment, including, but not limited to: prednisone ≥ 20 mg per day, azathioprine, methotrexate, anti-tumor necrosis factor agents, anti-interleukin-6/6R agents, or anti-interleukin 1 agents, are not eligible. The use of inhaled corticosteroids is permitted
Patients with known or suspected chronic active Epstein Barr virus (EBV) or cytomegalovirus (CMV) infection
Patients with known or suspected history of hemophagocytic lymphohistiocytosis (HLH)
Patients with prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3
Patients with known history of progressive multifocal leukoencephalopathy
Patients with current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator are allowed
Patients with the significant cardiovascular disease, including New York Heart Association class III or IV or otherwise symptomatic heart failure (stage C or D), myocardial infarction within the last 3 months, unstable arrhythmias, or unstable angina
Patients who have undergone major surgery for non-diagnostic purposes within 4 weeks before first study treatment
Patients who have received a live attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study
Patients with a positive SARS-CoV-2 test 7 days prior to enrollment
Patients with current or past history of Waldenström macroglobulinemia
Patients with an active autoimmune disease that could be exacerbated by immunotherapy, excluding those with a remote history or well-controlled autoimmune disease
What this trial measures
- Objective response rateUp to 2 years
A Simon 2-stage optimal design will be used with a favorable response of 55% and unfavorable response of 25%.