OncoMatch/Clinical Trials/NCT03331198
Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
Is NCT03331198 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including JCAR017 (lisocabtagene maraleucel) and JCAR017 (lisocabtagene maraleucel) + ibrutinib for leukemia, lymphocytic, chronic, b-cell.
Treatment: JCAR017 (lisocabtagene maraleucel) · JCAR017 (lisocabtagene maraleucel) + ibrutinib · JCAR017 (lisocabtagene maraleucel) + venetoclax — This is a Phase 1/2, open-label, multicenter study to determine the efficacy and safety of JCAR017 in adult subjects with relapsed or refractory CLL or SLL. The study will include a Phase 1 part to determine the recommended dose of JCAR017 monotherapy in subjects with relapsed or refractory CLL or SLL, followed by a Phase 2 part to further assess the efficacy and safety of JCAR017 monotherapy treatment at the recommended dose. A separate Phase 1 cohort will assess the combination of JCAR017 and concurrent ibrutinib. Another separate Phase 1 cohort will assess the combination of JCAR017 and concurrent venetoclax. In all subjects, the safety, efficacy, and pharmacokinetics (PK) of JCAR017 will be evaluated.
Check if I qualifyExtracted eligibility criteria
Cancer type
Non-Hodgkin Lymphoma
Biomarker criteria
Required: CD19 positive disease
If prior CD19-targeted therapy has been administered, subject must have CD19-positive disease confirmed by immunohistochemistry or flow cytometry since completing the prior CD19-targeted therapy.
Allowed: BTK mutation
have BTK or PLCgamma2 mutations per local laboratory assessment, with or without progression on ibrutinib
Allowed: PLCG2 mutation
have BTK or PLCgamma2 mutations per local laboratory assessment, with or without progression on ibrutinib
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: Bruton tyrosine kinase inhibitor
must have received and failed Bruton tyrosine kinase inhibitor (BTKi) treatment or have been deemed ineligible for BTKi therapy
Must have received: BCL2 inhibitor (venetoclax) — DEME cohort
DEME cohort ONLY: ...must have received at least 2 lines of prior therapy including a BTKi and a BCL2i
Cannot have received: gene therapy product
Prior treatment with any gene therapy product
Lab requirements
Blood counts
hemoglobin >=9 g/dL, absolute neutrophil count >=500/mm3 and platelets>= 75,000/mm3, unless cytopenias are judged by investigator to be due to CLL infiltration of the bone marrow
Kidney function
Serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance > 30 mL/min
Liver function
Alanine aminotransferase ≤ 5 × ULN and total bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with Gilbert's syndrome or leukemic infiltration of the liver)
Cardiac function
left ventricular ejection fraction ≥ 40% as assessed by echocardiogram or multiple uptake gated acquisition scan performed within 30 days prior to determination of eligibility
Adequate organ function, defined as: Serum creatinine ≤ 1.5 × age-adjusted upper limit of normal (ULN) OR calculated creatinine clearance > 30 mL/min; Alanine aminotransferase ≤ 5 × ULN and total bilirubin < 2.0 mg/dL (or < 3.0 mg/dL for subjects with Gilbert's syndrome or leukemic infiltration of the liver); Adequate pulmonary function, defined as ≤ CTCAE Grade 1 dyspnea and saturated oxygen (SaO2) ≥ 92% on room air; Adequate cardiac function, defined as left ventricular ejection fraction ≥ 40% as assessed by echocardiogram or multiple uptake gated acquisition scan performed within 30 days prior to determination of eligibility
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Stony Brook University · Stony Brook, New York
- University of Alabama at Birmingham · Birmingham, Alabama
- University of Alabama Birmingham · Birmingham, Alabama
- Banner MD Anderson Cancer Center · Gilbert, Arizona
- Banner MD Anderson Cancer Center · Gilbert, Arizona
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