- Documented CD19+ CLL or SLL
- Successful test expansion -cells (as described in Section 6.1)
- Patients must have failed at least 1 prior regimen before Ibrutinib (not including single agent rituximab or single agent corticosteroids)
a. Note: Any relapse after prior autologous SCT will make the patient eligible regardless of other prior therapy.
- Patients must be currently receiving ibrutinib for at least 6 months prior to enrollment in the study and:
1. Not experiencing any ≥ grade 2 non-hematologic ibrutinib-related toxicity
2. The best response to ibrutinib therapy must not have exceeded partial response or stable disease (i.e. no CR or CRi)
3. Note: Patients carrying a deletion at chromosome 17p (i.e. del[17p]), and/or TP53, BTK, and at the PLCγ2 loci mutations, will be eligible if they are receiving frontline therapy with ibrutinib.
- ECOG Performance status 0 or 1
- 18 years of age and older
- Adequate organ system function including:
1. Creatinine < 1.6 mg/dl
2. ALT/AST < 3x upper limit of normal
3. Total Bilirubin <2.0 mg/dl with the exception of patients with Gilbert syndrome; patients with Gilbert syndrome may be included if their total bilirubin is ≥ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN.
- Patients with relapsed disease after prior allogeneic SCT (myeloablative or nonmyeloablative) will be eligible if they meet all other inclusion criteria and:
1. Have no active GVHD and require no immunosuppression
2. Are more than 6 months from transplant
- No contraindications for leukapheresis
- Left Ventricular Ejection fraction >40%
- Gives voluntary informed consent
- Subjects of reproductive potential must agree to use acceptable birth control methods.
- CLL patients with known or suspected transformed disease (i.e. Richter's transformation). Note: biopsy proven absence of transformation is not required.
- Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary.
- Any uncontrolled active medical disorder that would preclude participation as outlined.
- HIV infection.
- Patients with active CNS involvement with malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment.
- Class III/IV cardiovascular disability according to the New York Heart Association Classification.
- Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment.
- Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.
|Maximum Eligible Age:||N/A|
|Minimum Eligible Age:||18 Years|