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

NCT07453095 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: FIL_GOLD
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Mantle Cell Lymphoma

Keywords

Mantle Cell Lymphoma; MCL; CAR T cell; Inadequate response; Relapse

Outcome Measures

Primary Outcomes (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.

  27 months

Secondary Outcomes (7)

• Overall Response Rate (ORR)

  27 months

• Progression Free Survival (PFS)

  51 months

• Overall Survival (OS)

  51 months

• Duration of Response (DOR)

  51 months

• Time to Next Treatment (TTNT)

  51 months

Other Outcomes (1)

• MRD evaluation PCR (RQ-PCR) and NGS

  33 months

Study Arms (1)

Single arm

EXPERIMENTAL

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

Interventions

Glofitamab DRUG

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

Also known as: RO7082859

Single arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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.
• 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;
• 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).

You may not qualify 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).
• 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;

Sponsors & Collaborators

• Fondazione Italiana Linfomi - ETS: lead

Study Sites (14)

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

Alessandria, Italy

Location

Policlinico S.Orsola-Malpighi - Istituto di Ematologia Seragnoli

Bologna, Italy

Location

ASST Spedali Civili - Ematologia

Brescia, Italy

Location

Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

Florence, Italy

Location

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

Genova, Italy

Location

ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

Milan, Italy

Location

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

Palermo, Italy

Location

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

Pescara, Italy

Location

Azienda Ospedaliera Universitaria Pisana - U.O. Ematologia

Pisa, Italy

Location

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

Reggio Calabria, Italy

Location

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

Roma, Italy

Location

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

Torino, Italy

Location

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

Verona, Italy

Location

ULSS 8 Berica - Ospedale S. Bortolo - Ematologia

Vicenza, Italy

Location

MeSH Terms

Conditions

Lymphoma, Mantle-Cell; Recurrence

Interventions

glofitamab

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• 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 CHAIR

Central Study Contacts

Uffici Studi FIL

CONTACT

+390131033153; startup@filinf.it

Uffici Studi FIL

CONTACT

+390599769913; gestionestudi@filinf.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 16, 2026
• First Posted: March 5, 2026
• Study Start: April 15, 2026
• Primary Completion (Estimated): July 15, 2028
• Study Completion (Estimated): June 15, 2030
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• 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.
• 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.

Locations

IT (14)