OncoMatch/Clinical Trials/NCT06482684
CAR-T-cell Treatment for Untreated High Risk MANtle Cell Lymphoma
Is NCT06482684 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Targeted therapy
Other
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)
Demographics
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.
Frequently asked questions
Is NCT06482684 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require CCND1?
Yes, CCND1 overexpression is a required biomarker for enrollment.
Does this trial require CCND1?
Yes, CCND1 t(11;14) is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or III or IV is required.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages