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Study of glofitamab, obinutuzumab and tocilizumab in patients with mantle cell lymphoma relapsed or refractory after CAR‑T therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

Mantle Cell Lymphoma is a rare form of blood cancer that starts in the lymph nodes, which are small glands that help the body fight infection. Some patients have already received a type of immune therapy called CAR T-cell therapy, where a person’s own immune cells are changed in a lab to attack the cancer, but the disease can still come back or not improve enough. This study will give an experimental medicine named glofitamab directly into a vein (intravenous use). The treatment may be given in low or higher doses and will be combined with two other medicines, obinutuzumab and tocilizumab, which are also given by IV infusion.

The purpose of the study is to evaluate how well glofitamab works in people whose disease has returned or did not respond well after CAR T-cell therapy. Participants will receive a series of IV infusions over several months, with regular doctor visits and imaging scans to check whether the cancer shrinks or disappears. Terms such as “response” mean a measurable reduction in tumor size, and “complete response” means no detectable cancer remains on the scans. The study will follow each participant for about a year to see how long any benefit lasts and to monitor any side effects.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment and baseline assessment
After joining the study, a series of initial tests are performed to record the current health status and the extent of mantle cell lymphoma. these tests provide reference points for later comparison.
Step 2
First intravenous infusion of obinutuzumab
The patient receives obinutuzumab by intravenous (iv) infusion. the dose is 2000 mg. the infusion is administered in a clinical setting under professional supervision.
Step 3
Administration of tocilizumab as pre‑medication
Immediately before the study drug, the patient receives tocilizumab by iv infusion. the dose is 1600 mg. this medication helps reduce potential infusion‑related reactions.
Step 4
Initial dose of glofitamab
The patient receives the first dose of glofitamab by iv infusion. the initial dose is 2.5 mg. this low starting dose is used to assess tolerance.
Step 5
Subsequent doses of glofitamab
After the initial dose, the patient continues to receive glofitamab by iv infusion at a dose of 30 mg. the exact frequency and total number of administrations are defined by the study protocol and are followed as scheduled.
Step 6
Response assessments at 6 and 12 months
The patient undergoes evaluation of disease response at approximately 6 months (c6) and 12 months (c12) after starting treatment. these assessments determine whether the lymphoma shows a complete or partial response according to standard criteria.
Step 7
Ongoing safety monitoring
Throughout the treatment period, the patient is regularly monitored for any adverse events. safety checks include laboratory tests, physical examinations, and reporting of symptoms.
Step 8
Completion of treatment and final evaluation
When the planned series of glofitamab infusions is finished, a final evaluation is performed to document the overall response, progression‑free survival, and overall survival outcomes.

Who can join the trial?

20 criteria

Informed consent: You must sign a written form approved by the ethics committee and understand what the study involves.
Age must be 18 years or older.
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You must have received CAR‑T cell therapy for relapsed or refractory mantle cell lymphoma at least 30 days before signing the consent, and you must meet one of these situations after the CAR‑T infusion:
- Disease that is stable or getting worse up to 90 days after the infusion.
- Partial improvement (partial response) measured at 90 days after the infusion.
- Any new relapse that occurs after the infusion.
- You must not have ongoing severe neurotoxicity (nerve‑related side effects) from the CAR‑T treatment; severe is defined as a grade higher than 3.
- Any side effects from previous cancer treatments must have improved to mild (grade 1 or less), except for blood‑related side effects.
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  Your blood counts must be adequate:
  - White blood cells called neutrophils must be higher than 1.0 × 10⁹/L, unless the lymphoma is in the bone marrow.
  - Platelet count must be at least 50,000 per mm³, unless the lymphoma involves the bone marrow.
  - Hemoglobin (a protein that carries oxygen) must be at least 8.0 g/dL.
  - Your kidney function must be adequate, measured by a creatinine clearance of 30 mL/min or more (calculated with the Cockcroft‑Gault formula).
  - Your liver function must be adequate:
    
    Enzymes AST and ALT must be no more than three times the normal upper limit.
    The bile pigment bilirubin must be no more than 1.5 times the normal upper limit, unless the increase is due to a non‑liver cause.
    You must be able to attend all study visits and follow the study procedures.
    Your expected remaining lifespan must be longer than 12 weeks.
    You must have an ECOG Performance Status of 0, 1, or 2 (meaning you are fully active, restricted in physically strenuous activity, or capable of self‑care but unable to work).
    Women who could become pregnant must have a negative pregnancy test at screening.
    Women of childbearing potential must use effective birth control while receiving the study drugs and for the required period after each drug (2 months after glofitamab, 18 months after obinutuzumab, and 3 months after tocilizumab).
    Male participants with a partner who could become pregnant must use effective contraception for the required period (2 months after glofitamab, 3 months after obinutuzumab, and 2 months after tocilizumab).
    You must have a confirmed diagnosis of mantle cell lymphoma that is CD20‑positive (shown by flow cytometry or immunohistochemistry) after the CAR‑T therapy failed, and tissue samples must be available for central pathology review.

Who cannot join the trial?

15 criteria

You have already been treated with a special medicine that targets both CD20 and CD3 proteins (called an anti‑CD20xCD3 bispecific antibody); this prevents you from joining the study.
You have ever had macrophage activation syndrome (MAS) or hemophagocytic lymphohistiocytosis (HLH), which are severe, uncontrolled immune reactions.
You have received a donor stem cell transplant (called allogeneic hematopoietic stem cell transplantation).
You have a history of progressive multifocal leukoencephalopathy (PML), a serious brain infection.
You have any autoimmune disease, such as heart inflammation (myocarditis), lung inflammation (pneumonitis), muscle weakness (myasthenia gravis), muscle inflammation (myositis), autoimmune liver disease, lupus, rheumatoid arthritis, inflammatory bowel disease, blood‑clotting problems linked to antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain‑Barré syndrome, multiple sclerosis, vasculitis, or kidney inflammation (glomerulonephritis).
Your lymphoma involves the central nervous system (brain or spinal cord).
You have received any cancer treatment—such as chemotherapy, immunotherapy, radiation, or experimental drugs—within the 14 days before the first study medication.
You have moderate to severe heart disease, described as New York Heart Association (NYHA) class 2 or higher.
You have a significant past of neurological, psychiatric, hormonal (endocrine), metabolic, immune system, or liver illnesses that could make participation unsafe or affect your ability to give consent.
You have an uncontrolled infection (viral, bacterial, or fungal), including an active COVID‑19 infection.
You have chronic hepatitis B or hepatitis C that currently requires treatment.
You are HIV positive (have the HIV virus in your blood).
If you are a woman, you are currently pregnant or are breastfeeding.
You are unable to give informed consent (cannot understand and agree to the study procedures).
You have previously experienced serious immune‑related side effects from cancer immunotherapy, including any side effect graded 3 or higher (except certain hormone problems that can be treated), or mild‑to‑moderate side effects that have not fully resolved after stopping the prior treatment.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Responsive
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Palermo, Italy
Responsive
Azienda Ospedaliero Universitaria Careggi
Florence, Italy
Responsive
Universita Degli Studi Di Roma La Sapienza
Rome, Italy

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Investigated drugs

Glofitamab
is a laboratory‑made antibody that is given through a vein. In this study it is being tested as a new treatment for patients whose mantle‑cell lymphoma has come back or did not respond well after they received CAR‑T cell therapy. The drug is designed to recognize and attach to the cancer cells, helping the body’s immune system to find and destroy them.
Obinutuzumab
is also an antibody given intravenously. It works by targeting a protein called CD20 that is found on many B‑cell cancers, including mantle‑cell lymphoma. In the trial it is used together with other medicines to help the immune system attack the cancer cells.
Tocilizumab
is a medication that blocks a part of the immune system called the interleukin‑6 receptor. It is given by vein and is used in the study as background therapy to control inflammation and side effects, such as severe immune reactions, that can occur during treatment.

What is already known about the treatment

Glofitamab
This medication is given by slow intravenous infusion. It is still investigational and is being studied in clinical trials for treating mantle‑cell lymphoma that has returned after other therapies. Glofitamab works by attaching to a protein called CD20 on cancer B‑cells and to CD3 on T‑cells, pulling the immune cells close to the cancer cells so they can be destroyed. It belongs to the class of bispecific T‑cell‑engaging monoclonal antibodies, a type of immunotherapy.
Obinutuzumab
This drug is administered by intravenous infusion. It is an approved treatment for several B‑cell cancers, including chronic lymphocytic leukemia and follicular lymphoma, and is also used in studies of mantle‑cell lymphoma. Obinutuzumab binds to the CD20 protein on B‑cells, marking them for removal by the immune system. It is classified as a monoclonal antibody that targets CD20, a form of targeted immunotherapy.
Tocilizumab
This agent is given by intravenous infusion. It is an approved medication for conditions such as rheumatoid arthritis and cytokine‑release syndrome and is used as a background therapy in some lymphoma studies. Tocilizumab blocks the receptor for interleukin‑6, a signal that drives inflammation, thereby reducing inflammatory activity. It is categorized as an interleukin‑6 receptor antagonist, a biologic anti‑inflammatory drug.

Investigated diseases

Mantle cell lymphoma - Mantle cell lymphoma is a rare type of blood cancer that starts in B‑cells within the outer edge (mantle zone) of lymph nodes. It often causes enlarged lymph nodes and can spread to the spleen, bone marrow, or other organs. The disease may grow slowly at first, but in some people it can become more aggressive and involve additional parts of the blood‑forming system. As it progresses, symptoms such as fatigue, weight loss, or night sweats may appear.