This study is an open-label, multicenter, proof of concept, phase 2 trial. Patients will be recruited over 18 months. Safety analysis will be performed with a stop of the enrollment after 3 patients have either 1 complete treatment cycle or permanently discontinued treatment whichever occurs first.
Approximatively 65 patients with aggressive large B-cell lymphoma (LBCL) (including diffuse large B-cell lymphoma (DLBCL), Primary mediastinal B-cell lymphoma (PMBCL), any transformed follicular or marginal zone lymphoma, high-grade B-cell lymphoma (HGBL)) will be enrolled in the study.
The duration of treatment with golcadomide (CELMoD) is 24 weeks with 6 cycles of 28 days (4 weeks), starting at 5 days after CAR-T cells infusion.
The primary objective of the study is to estimate the efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion, Efficacy determination will be based upon the primary endpoint of complete metabolic response (CMR) rate at 3 months after infusion of anti-CD19 CAR T-cell assessed by study investigator.
Patient who understood and voluntarily signed and dated an informed consent prior to any study-specific assessments/procedures being conducted
Adults patients (≥ 18-year-old at the time of signing the informed consent form; no upper age limit)
Eligible for any commercialized market authorized anti-CD19 CAR T-cells
Performance Status 0, 1, or 2
History of malignancy other than non-melanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) unless disease free for at least 3 years
Presence or suspicion of fungal, bacterial, viral, or other infection that is uncontrolled or requiring IV antimicrobials for management; simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the sponsor's medical monitor
History of human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection; subjects with history of hepatitis infection must have cleared their infection as determined by standard serological and genetic testing per current Infectious Diseases Society of America guidelines or applicable country guidelines
Significant pulmonary function impairment and oxygen saturation (SaO2) < 92% on room air
Single group
golcadomide
Druggolcadomide 0.3 mg weekly from D+5 post CAR T-cells administration until D+166
Complete metabolic response rate (CMR rate)
efficacy of golcadomide administered post-anti-CD19 CAR T-cell infusion
Objective response rate (ORR)
incidence of either a complete (CMR) or a partial (PMR) metabolic response per the Lugano Classification (Cheson 2014) as determined by study investigators
Objective response rate (ORR)
determined by imaging central review
Complete response rate (CRR)
percentage of complete response determined by investigator assessment classification
Duration of response (DR)
time from attainment of PMR or CMR to the date of first documented disease progression/relapse (based on investigator disease assessment (INV)) or death from any cause
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The Lymphoma Academic Research Organisation
Lead sponsor
Lymphoma Study Association
Collaborator
