AzTrials
AzTrials

Mantle Cell LymphomaPhase 2NCT07453095

Study With Glofitamab in Patients With MCL and Inadequate Response or Relapse Following CAR T-cell Therapy

A Phase 2 study testing Glofitamab in people with Mantle Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 14 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mantle Cell Lymphoma
What is being tested?
Glofitamab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
14 sitesItaly
Study dates
5 Jun 2026to 15 Jun 2030
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to 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.
  • 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.
  • 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;
Show all 24Show fewer
  • 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.

Who cannot join

  • 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).
Show all 18Show fewer
  • 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:
  • 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 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.

Trial locations and contacts

14 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Uffici Studi FIL contact

+390131033153

startup@filinf.it

Uffici Studi FIL contact

+390599769913

gestionestudi@filinf.it

14 sites in 1 country

Italy14 sites, 14 recruiting

  • AOU SS. Antonio e Biagio e Cesare Arrigo - SCDU Ematologia

    Alessandria

    Marco Ladetto, Prof, marco.ladetto@uniupo.it

    Marco Ladetto, Prof

    Not yet recruiting

  • Policlinico S.Orsola-Malpighi - Istituto di Ematologia Seragnoli

    Bologna

    Pier Luigi Zinzani, Prof, pierluigi.zinzani@unibo.it

    Pier Luigi Zinzani, Prof

    Not yet recruiting

  • ASST Spedali Civili - Ematologia

    Brescia

    Chiara Pagani, MD, chiara.pagani@asst-spedalicivili.it

    Chiara Pagani, MD

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

    Florence

    Luca Nassi, MD, nassil@aou-careggi.toscana.it

    Luca Nassi, MD

    Not yet recruiting

  • Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia - Ematologia e terapie cellulari

    Genova

    Chiara Ghiggi, MD, chiara.ghiggi@hsanmartino.it

    Chiara Ghiggi, MD

    Not yet recruiting

  • ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

    Milan

    Vittorio Ruggero Zilioli, MD, vittorioruggero.zilioli@ospedaleniguarda.it

    Vittorio Ruggero Zilioli, MD

    Not yet recruiting

  • A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia

    Palermo

    Caterina Patti, MD, k.patti@villasofia.it

    Caterina Patti, MD

    Not yet recruiting

  • P.O. Spirito Santo di Pescara - UOC Ematologia Dipartimento Oncologico Ematologico - ASL Pescara

    Pescara

    Elsa Pennese, MD, elsa.pennese@asl.pe.it

    Elsa Pennese, MD

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Pisana - U.O. Ematologia

    Pisa

    Sara Galimberti, Prof, sara.galimberti@med.unipi.it

    Sara Galimberti, Prof

    Not yet recruiting

  • Grande Ospedale Metropolitano Bianchi Melacrino Morelli - C.T.M.O.

    Reggio Calabria

    Massimo Martino, MD, dr.massimomartino@gmail.com

    Massimo Martino, MD

    Recruiting

  • Policlinico Umberto I - Universitа "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione

    Roma

    Alice Di Rocco, MD, dirocco@bce.uniroma1.it

    Alice Di Rocco, MD

    Not yet recruiting

  • A.O.U. Città della Salute e della Scienza - Ematologia Universitaria

    Torino

    Simone Ferrero, Prof, simone.ferrero@unito.it

    Simone Ferrero, Prof

    Not yet recruiting

  • Azienda Ospedaliera Universitaria Integrata di Verona - U.O. Ematologia

    Verona

    Carlo Visco, Prof, carlo.visco@univr.it

    Carlo Visco, Prof

    Not yet recruiting

  • ULSS 8 Berica - Ospedale S. Bortolo - Ematologia

    Vicenza

    Maria Chiara Tisi, mariachiara.tisi@aulss8.veneto.it

    Maria Chiara Tisi, MD

    Not yet recruiting

Other trials in Italy

About this study

Official title: A Phase II, Multicenter Study of GlOfitamab in Patients With Mantle Cell Lymphoma and inaDequate Response or Relapse Following CAR T-cell Therapy (GOLD)

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.

Read the detailed description

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. Patients experiencing failure after CAR-T cell treatment will be screened for inclusion and exclusion criteria for treatment and, if eligible, will enter the study.

Safety events will be analyzed and compared with the previously described safety profile of glofitamab alone and other bispecific-containing regimens to exclude the risk of potential toxicity for all study participants.

The study will include a period of screening phase, a period of treatment phase and a follow up phase.

Being tested
Glofitamab
Keywords
Mantle Cell Lymphoma, MCL, CAR T cell, Inadequate response, Relapse
Medical subject headings
Lymphoma, Mantle-Cell, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlofitamabDrug

    Also called RO7082859

    Glofitamab treatment in post CAR-T R/R MCL patients

Study groups in NCT07453095
Study groupRoleWhat they receive
Single armExperimentalPatients enrolled and with confirmed eligibility will be treated according to the following schedule: * Obinutuzumab (2000 mg) will be administered 7 days before (Day 1, Cycle1) the first glofitamab dose; * Glofitamab treatment for 12 cycles: intravenous glofitamab will be administered with step-up dosing on D8 (2.5mg), D15 (10mg) of Cycle (C) 1 and at 30mg on D1 of C2-12 (21-day cycles).
Receives: Drug: Glofitamab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete Response Rate (CRR)

    Complete Response Rate (CRR) at the end of treatment (C12) (assessed by the independent review committee according to Lugano 2014 criteria) and at any time during study treatment.

    Measured: 27 months

Secondary outcomes (7)

  1. Overall Response Rate (ORR)

    Overall Response Rate (ORR) defined as the proportion of patients achieving either a Complete Response (CR) or Partial Response (PR) (assessed by the independent review committee according to Lugano 2014 criteria), and evaluated at C6 and C12.

    Measured: 27 months

  2. Progression Free Survival (PFS)

    Progression Free Survival (PFS) defined as the time from the study inclusion to disease progression or death from any cause.

    Measured: 51 months

  3. Overall Survival (OS)

    Overall Survival (OS) defined as the time between the study inclusion and death from any cause.

    Measured: 51 months

  4. Duration of Response (DOR)

    Duration of Response (DOR) defined as the time from the first documentation of tumor response (Complete or Partial Response) to disease progression or death.

    Measured: 51 months

  5. Time to Next Treatment (TTNT)

    Time to Next Treatment (TTNT) defined as the time represents the interval from the study inclusion to initiation of the next line of therapy.

    Measured: 51 months

  6. Event Free Survival (EFS)

    Event Free Survival (EFS) defined as the time from the study inclusion to disease progression, death, or Next Anti-Lymphoma Treatment (NALT) start.

    Measured: 51 months

  7. AEs

    Frequency and severity of adverse events (AEs) classified as per CTCAE (Common Terminology Criteria for Adverse Events) latest version and SAE.

    Measured: 51 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2026
  2. Study start5 Jun 2026
  3. Primary completion15 Jul 2028 (estimated)
  4. Study completion15 Jun 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
41 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07453095
Sponsor's protocol ID
FIL_GOLD
Status last verified
Jun 2026
First submitted
16 Feb 2026
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may contact the FIL board at segreteriadirezione@filinf.it to share invidual-level patients' clinical data analysed for this manuscript (for the avoidance of doubt, no identifiable data, such as name, address, hospital name, date of birth, or any other identifying data, will be shared and should not be requested).

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Glofitamab in people with Mantle Cell Lymphoma, run by Fondazione Italiana Linfomi - ETS at 14 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 24 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Uffici Studi FIL (+390131033153, startup@filinf.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response Rate (CRR) (time frame: 27 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07453095.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in