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

April 14, 2026 updated by: Fondazione Italiana Linfomi - ETS

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

41

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Alessandria, Italy
        • AOU SS. Antonio e Biagio e Cesare Arrigo - SCDU Ematologia
        • Contact:
        • Principal Investigator:
          • Marco Ladetto, Prof
      • Bologna, Italy
        • Policlinico S.Orsola-Malpighi - Istituto di Ematologia Seragnoli
        • Contact:
        • Principal Investigator:
          • Pier Luigi Zinzani, Prof
      • Brescia, Italy
      • Florence, Italy
        • Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia
        • Principal Investigator:
          • Luca Nassi, MD
        • Contact:
      • Genova, Italy
        • Ospedale Policlinico San Martino S.S.R.L. - IRCCS per l'Oncologia - Ematologia e terapie cellulari
        • Contact:
        • Principal Investigator:
          • Chiara Ghiggi, MD
      • Milan, Italy
      • Palermo, Italy
        • A.O. Ospedali Riuniti Villa Sofia-Cervello - Divisione di Ematologia
        • Contact:
        • Principal Investigator:
          • Caterina Patti, MD
      • Pescara, Italy
        • P.O. Spirito Santo di Pescara - UOC Ematologia Dipartimento Oncologico Ematologico - ASL Pescara
        • Principal Investigator:
          • Elsa Pennese, MD
        • Contact:
      • Pisa, Italy
        • Azienda Ospedaliera Universitaria Pisana - U.O. Ematologia
        • Contact:
        • Principal Investigator:
          • Sara Galimberti, Prof
      • Reggio Calabria, Italy
        • Grande Ospedale Metropolitano Bianchi Melacrino Morelli - C.T.M.O.
        • Contact:
        • Principal Investigator:
          • Massimo Martino, MD
      • Roma, Italy
        • Policlinico Umberto I - Universitа "La Sapienza" - Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
        • Contact:
        • Principal Investigator:
          • Alice Di Rocco, MD
      • Torino, Italy
        • A.O.U. Città della Salute e della Scienza - Ematologia Universitaria
        • Contact:
        • Principal Investigator:
          • Simone Ferrero, Prof
      • Verona, Italy
        • Azienda Ospedaliera Universitaria Integrata di Verona - U.O. Ematologia
        • Contact:
        • Principal Investigator:
          • Carlo Visco, Prof
      • Vicenza, Italy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Age ≥ 18.

  4. 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.
  5. No persistent CAR-T neurotoxicity symptoms or previous experience during CAR T-cells therapy of severe neurotoxicity grade > 3
  6. Adverse events from prior anti-cancer therapy must have resolved to Grade ≤ 1 (hematological toxicities excepted).

  7. 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.

  8. Adequate renal function defined as follows:

    - Creatinine clearance ≥ 30 mL/min (Cockcroft-Gault formula).

  9. 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).
  10. Participants must be able to adhere to the study visit schedule and other protocol requirements.
  11. Life expectancy > 12 weeks.
  12. ECOG Performance Status of 0, 1, or 2.
  13. Women of childbearing potential must have a negative pregnancy test at screening.
  14. 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.
  15. 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.

Exclusion Criteria:

  1. Prior exposure to an anti-CD20xCD3 bispecific antibody (bsAbs).
  2. Participants not able to give consent.

  3. 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.
  4. Patients with history of macrophage activation syndrome (MAS) / hemophagocytic lymphohistiocytosis (HLH).
  5. Allogeneic hematopoietic stem cell transplantation.
  6. History of progressive multifocal leukoencephalopathy (PML).
  7. 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.
  8. CNS involvement with lymphoma.
  9. 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.
  10. Cardiovascular disease [NYHA class ≥2].
  11. 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.

  12. Evidence of other clinically significant uncontrolled condition(s) included, but not limited to:

    1. Uncontrolled and/or active systemic infection (viral, bacterial or fungal), including active ongoing infection from SARS-CoV-2;
    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;
  13. HIV seropositivity.
  14. If female, the patient is pregnant or breast-feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Single arm

Patients 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).
Drug: Glofitamab
Glofitamab treatment in post CAR-T R/R MCL patients
Other Names:
  • RO7082859

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complete Response Rate (CRR)
Time Frame: 27 months
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.
27 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: 27 months
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.
27 months
Progression Free Survival (PFS)
Time Frame: 51 months
Progression Free Survival (PFS) defined as the time from the study inclusion to disease progression or death from any cause.
51 months
Overall Survival (OS)
Time Frame: 51 months
Overall Survival (OS) defined as the time between the study inclusion and death from any cause.
51 months
Duration of Response (DOR)
Time Frame: 51 months
Duration of Response (DOR) defined as the time from the first documentation of tumor response (Complete or Partial Response) to disease progression or death.
51 months
Time to Next Treatment (TTNT)
Time Frame: 51 months
Time to Next Treatment (TTNT) defined as the time represents the interval from the study inclusion to initiation of the next line of therapy.
51 months
Event Free Survival (EFS)
Time Frame: 51 months
Event Free Survival (EFS) defined as the time from the study inclusion to disease progression, death, or Next Anti-Lymphoma Treatment (NALT) start.
51 months
AEs
Time Frame: 51 months
Frequency and severity of adverse events (AEs) classified as per CTCAE (Common Terminology Criteria for Adverse Events) latest version and SAE.
51 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRD evaluation PCR (RQ-PCR) and NGS
Time Frame: 33 months
MRD will be analyzed using both quantitative real-time PCR (RQ-PCR) and nextgeneration sequencing (NGS) on BM, PB and plasma samples using the most validated Euro-MRD standardized procedures
33 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Italiana Linfomi - ETS

Investigators

  • Study Chair: Marco Ladetto, Prof, Dipartimento Medicina Traslazionale, Università del Piemonte Orientale - S.C. Ematologia ed Infrastruttura Ricerca Formazione ed Innovazione, A.O. SS. Antonio e Biagio e C. Arrigo (Alessandria, Italy)
  • Study Chair: Rita Tavarozzi, MD, Dipartimento Medicina Traslazionale, Università del Piemonte Orientale - S.C. Ematologia ed Infrastruttura Ricerca Formazione ed Innovazione, A.O. SS. Antonio e Biagio e C. Arrigo (Alessandria, Italy)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2026

Primary Completion (Estimated)

July 15, 2028

Study Completion (Estimated)

June 15, 2030

Study Registration Dates

First Submitted

February 16, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

April 17, 2026

Last Update Submitted That Met QC Criteria

April 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FIL_GOLD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing Time Frame

In compliance with the domestic ethics guideline and applicable legislation, invidual deindentified patients' data underlying the results reported in the publication article (including study protocol, statistical analysis plan and data coding) can be shared until 5 years after the publication of the article.

IPD Sharing Access Criteria

For each data sharing request, it is essential that a proforma (available on request) is completed that describes the general purpose, specific aims, data items requested, analysis plan and acknowledgment of the trial management team. Requests will be reviewed based on scientific merit and ethical principles. Requestors who are granted access to the data will be required to complete a data sharing agreement that will be signed by the requester and FIL.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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