OncoMatch/Clinical Trials/NCT06482684
CAR-T-cell Treatment for Untreated High Risk MANtle Cell Lymphoma
Is NCT06482684 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including KTE-X19 and Ibrutinib for mantle cell lymphoma.
Treatment: KTE-X19 · Ibrutinib — First-line CAR-T-cell consolidation after an abbreviated induction with 2 cycles of Rituximab and Ibrutinib prior to CAR-T-cell treatment and followed by 6 months of maintenance with Ibrutinib in patients with high risk MCL.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CCND1 overexpression
documentation of either overexpression of cyclin D1
Required: CCND1 t(11;14)
presence of t(11;14)
Allowed: TP53 mutation
TP53-mutation
Allowed: TP53 overexpression
TP53-overexpression by immunohistochemistry (> 50% of lymphoma cells)
Disease stage
Required: Stage II, III, IV
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Blood counts
Absolute neutrophil count (ANC) ≥ 1000 cells/μL; Platelets ≥75,000 cells/μL
Kidney function
Creatinine <2 mg/dL or calculated creatinine clearance ≥60 mL/min
Liver function
Transaminases (AST and ALT) < 2.5 x ULN; Total bilirubin <= 2 x ULN unless other reason known (e.g. Gilbert-Meulengracht-Syndrome, or due to lymphoma involvement)
Cardiac function
LVEF below 50% excluded; Clinically significant cardiovascular disease such as symptomatic arrhythmias, congestive heart failure, higher grade AV-block, unstable angina, myocardial infarction, cardiac angioplasty or stenting within 12 months of Screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
The following laboratory values at screening (unless discrepancies are related to MCL): I. Absolute neutrophil count (ANC) ≥ 1000 cells/μL II. Platelets ≥75,000 cells/μL III. Creatinine <2 mg/dL or calculated creatinine clearance ≥60 mL/min IV. Transaminases (AST and ALT) < 2.5 x ULN V. Total bilirubin <= 2 x ULN unless other reason known (e.g. Gilbert-Meulengracht-Syndrome, or due to lymphoma involvement); Serious concomitant disease interfering with a regular therapy according to the study protocol: I. Clinically significant cardiovascular disease ... or LVEF below 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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