CompletedPhase 2

Treatment by a Bispecific CD3xCD20 Antibody for Relapse/Refractory Lymphomas After CAR T-cells Therapy

France67 participantsStarted 2021-03-30

Plain-language summary

This study is a multicenter phase II trial including 2 cohorts of patients in Refractory/Relapse disease at least 1 month after CAR T-cells therapy: * cohort 1: DLBCL patients * cohort 2: PMBL, mantle cell lymphoma, transformed indolent NHL (t-iNHL) or iNHL CAR T-cells Refractory/Relapse status will be determined by PET-CT central review allowing inclusion in this trial. Patients enrolled will then receive a pre-phase of obinutuzumab followed by experimental treatment:11 cycle of glofitamab. The primary objective of the study is to assess the anti-lymphoma activity of glofitamab, a bispecific CD3xCD20 monoclonal antibody in patients with relapse/refractory DLBCL (cohort 1) disease after anti-CD19 CAR T-cells therapy

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Patients who received CAR T-cells therapy for R/R DLBCL (cohort 1) or R/R PMBL, mantle cell lymphoma, t-iNHL or iNHL (cohort 2), at least 1 month ago
✓. Patients who are not, at least in partial metabolic response from 1 month after CAR T-cells infusion (i.e no metabolic response or first metabolic progressive disease or first relapse from 1 month after CAR T-cells infusion)
✓. First metabolic progression, first relapse or no metabolic response after CAR T-cells infusion must be confirmed by PET-CT central review for enrollment
✓. DLBCL with demonstrated lymphoma cells-expressing CD20 at relapse post CAR T-cells as demonstrated by biopsy before enrollment (cohort 1 only)
✓. Aged 18 years or more with no upper age limit
✓. ECOG performance status 0 or 1
✓. Bi-dimensionally measurable disease defined by at least one single node or tumor lesion \> 1.5 cm assessed by CT scan, or PET-CT with at least one hypermetabolic lesion
✓. No persistant CAR-T neurotoxicity symptoms or previous experience during CAR T-cells therapy of neurotoxicity grade \> 3

Exclusion criteria

What they're measuring

Overall Survival

Timeframe: 4 years

Trial details

NCT IDNCT04703686

SponsorThe Lymphoma Academic Research Organisation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-01-10

View on ClinicalTrials.gov More Diffuse Large B-Cell Lymphoma Refractory trials