Study With Glofitamab in Patients With MCL and Inadequate Response or Relapse Following CAR T-cel… (NCT07453095) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Study With Glofitamab in Patients With MCL and Inadequate Response or Relapse Following CAR T-cell Therapy
Italy41 participantsStarted 2026-04-15
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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 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:
✓. 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:
✓. Adequate renal function defined as follows:
Exclusion criteria
✕. 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: