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Study carried out at multiple centers to test Glofitamab in patients with mantle cell lymphoma who did not respond well to, or relapsed after, CAR T-cell therapy.
EU CTIS ID: 2025-523428-39-00
What this study is testing
To assess the activity of glofitamab treatment in post CAR-T R/R MCL patients
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Able to provide written informed consent forms approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study-specific procedures and able to understand and to comply with the requirements of the study and the schedule of assessments.
- Age ≥ 18
- Patients who received CAR T-cells therapy for R/R MCL at least 30 days prior to signing the informed consent form and who meet one of the following situations: - Stable disease (SD) or progressive disease (PD) up to D+90; after CAR T-cells infusion (from D+30 to D+90); - Partial response (PR) at D+90 after CAR-T cells infusion; - Relapsed disease at any time after CAR-T cells infusion.
- No persistent CAR-T neurotoxicity symptoms or previous experience during CAR T-cells therapy of severe neurotoxicity grade > 3
- Adverse events from prior anti-cancer therapy must have resolved to Grade ≤ 1 (hematological toxicities excepted).
- Adequate hematological counts are defined as follows: - Absolute neutrophil count (ANC) > 1.0 x 109/L unless due to bone marrow involvement by lymphoma; - Platelet count ≥ 50.000/mm3 unless due to bone marrow involvement by lymphoma; - Hemoglobin ≥ 8.0 g/dL.
You likely can't join if
- Prior exposure to an anti-CD20xCD3 bispecific antibody (bsAbs).
- Patients with history of macrophage activation syndrome (MAS) / hemophagocytic lymphohistiocytosis (HLH).
- Allogeneic hematopoietic stem cell transplantation.
- History of progressive multifocal leukoencephalopathy (PML).
- History of autoimmune disease, including, but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- CNS involvement with lymphoma.
See the full eligibility criteria
Who can join
- Able to provide written informed consent forms approved by the National Ethics Committee (NEC) prior to the initiation of any screening or study-specific procedures and able to understand and to comply with the requirements of the study and the schedule of assessments.
- Age ≥ 18
- Patients who received CAR T-cells therapy for R/R MCL at least 30 days prior to signing the informed consent form and who meet one of the following situations: - Stable disease (SD) or progressive disease (PD) up to D+90; after CAR T-cells infusion (from D+30 to D+90); - Partial response (PR) at D+90 after CAR-T cells infusion; - Relapsed disease at any time after CAR-T cells infusion.
- No persistent CAR-T neurotoxicity symptoms or previous experience during CAR T-cells therapy of severe neurotoxicity grade > 3
- Adverse events from prior anti-cancer therapy must have resolved to Grade ≤ 1 (hematological toxicities excepted).
- Adequate hematological counts are defined as follows: - Absolute neutrophil count (ANC) > 1.0 x 109/L unless due to bone marrow involvement by lymphoma; - Platelet count ≥ 50.000/mm3 unless due to bone marrow involvement by lymphoma; - Hemoglobin ≥ 8.0 g/dL.
- Adequate renal function defined as follows: - Creatinine clearance ≥ 30 mL/min (Cockcroft–Gault formula).
- Adequate hepatic function per local laboratory reference range as follows (unless due to lymphoma): - Aspartate transaminase (AST) and alanine transaminase (ALT) ≤ 3.0 x ULN; - Bilirubin ≤1.5 x ULN (unless bilirubin rise is due to Gilbert’s syndrome or of non-hepatic origin).
- Participants must be able to adhere to the study visit schedule and other protocol requirements.
- Life expectancy > 12 weeks.
- ECOG Performance Status of 0, 1, or 2.
- Women of childbearing potential must have a negative pregnancy test at screening.
- Women of childbearing potential must take necessary precautions to avoid pregnancy while receiving study treatments and for 2 months after the last dose of glofitamab, for 18 months after the last dose of obinutuzumab and for 3 months after the last dose of tocilizumab.
- Male patient with a female partner of childbearing potential must agree to use an acceptable method of contraception for the duration of the study and for 2 months after the last dose of glofitamab, for 3 months after the last dose of obinutuzumab and for 2 months after the last dose of tocilizumab.
- Histologically confirmed MCL after CAR T-cells failure (CD20+ by flow cytometry or immunohistochemistry). Note: Availability of archival material is mandatory for the study to perform central pathology review. Central pathology confirmation is not required to start treatment.
What rules you out
- Prior exposure to an anti-CD20xCD3 bispecific antibody (bsAbs).
- Patients with history of macrophage activation syndrome (MAS) / hemophagocytic lymphohistiocytosis (HLH).
- Allogeneic hematopoietic stem cell transplantation.
- History of progressive multifocal leukoencephalopathy (PML).
- History of autoimmune disease, including, but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis.
- CNS involvement with lymphoma.
- Participant has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy, including targeted small molecule agents within 14 days prior to the first dose of study drug.
- Cardiovascular disease [NYHA class ≥2]
- Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent.
- Evidence of other clinically significant uncontrolled condition(s) included, but not limited to: a. Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2; b. Chronic or acute hepatitis B virus (HBV) or hepatitis C (HCV) require treatment. Note: participants with serologic evidence of prior vaccination to HBV (i.e. hepatitis B surface (HBs) antigen (Ag) negative, anti-HBs antibody positive and anti-hepatitis B core (HBc) antibody negative) or positive anti-HBc antibody from previous infection or intravenous immunoglobulins (IVIG) may participate; inactive carriers (HBsAg positive with undetectable HBV- DNA) are eligible. Patients with presence of HCV antibody are eligible only if PCR negative for HCV-RNA
- HIV seropositivity.
- If female, the patient is pregnant or breast-feeding.
- Participants not able to give consent.
- History of treatment-emergent immune-related adverse events associated with prior immunotherapeutic agents, as follows: - Grade ≥ 3 adverse events except for Grade 3 endocrinopathy managed with replacement therapy; - Grade 1-2 adverse events that did not resolve to baseline after treatment discontinuation.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.