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New treatment option for Mantle Cell Lymphoma
Official title Study With Glofitamab in Patients With MCL and Inadequate Response or Relapse Following CAR T-cell Therapy
ClinicalTrials.gov ID: NCT07453095
What this study is testing
What is Glofitamab?
Glofitamab is an investigational medicine, being studied as a potential treatment for mantle cell lymphoma.
Also referred to as RO7082859.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 2, multicentre, single arm study that evaluates the efficacy and safety of glofitamab in MCL patients with inadequate response or relapse following CAR T-cell therapy.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
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...
- Histologically confirmed MCL after CAR T-cells failure (CD20+ by flow cytometry or immunohistochemistry). Note: Availability of archival material is...
- 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...
- Stable disease (SD) or progressive disease (PD) up to D+90; after CAR T-cells infusion (from D+30 to D+90);
You likely can't join if
- Prior exposure to an anti-CD20xCD3 bispecific antibody (bsAbs).
- 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.
- Patients with history of macrophage activation syndrome (MAS) / hemophagocytic lymphohistiocytosis (HLH).
See the full eligibility criteria
- 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...
- 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...
- 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...
- 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...
- Prior exposure to an anti-CD20xCD3 bispecific antibody (bsAbs).
- 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.
- 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...
- 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...
- 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:
- Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2;
- 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...
- HIV seropositivity.
- If female, the patient is pregnant or breast-feeding.
The study team makes the final eligibility decision.
Where it's taking place
- Alessandria, Italy
- Bologna, Italy
- Brescia, Italy
- Florence, Italy
- Genova, Italy
- Milan, Italy
- Palermo, Italy
- Pescara, Italy
- Pisa, Italy
- Reggio Calabria, Italy
- Roma, Italy
- Torino, Italy
- Verona, Italy
- Vicenza, Italy
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alessandria, Italy; Bologna, Italy; Brescia, Italy; Florence, Italy; Genova, Italy; Milan, Italy and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.