Retreatment With CTL019/CTL119

University of Pennsylvania

Status and phase: Begins enrollment in 2 months; Phase 1

Conditions: Lymphoma, B-Cell

Treatments: Drug: CD19 redirected autologous T cells (CTL019 or CTL119 cells)

Study type: Interventional

Funder types: Other

Identifiers

NCT04419909

834286 (Other Identifier)

UPCC 40419

Details and patient eligibility

About

This research study is designed to evaluate the effects of retreatment with CTL019/CTL119 in patients with late relapse of B-cell lymphomas.

Full description

This is a single arm open label trial that will assess the safety and efficacy of retreatment with CTL019/CTL119 chimeric antigen receptor (CAR) modified T cells in patients who have late relapse of diffuse large B-cell or follicular lymphoma after achieving complete remission from prior CTL019/CTL119 treatment. Patients eligible for this protocol will have been treated initially with CTL019/CTL119 under UPCC13413/NCT02030834, have experienced a durable complete response (defined as ≥ 6 months duration), and have a residual manufactured CTL019/CTL119 product available. This protocol will serve subjects with no available potentially curative treatment options (such as autologous or allogeneic stem cell transplantation) who have a limited prognosis (months to < 2 year expected survival) with available therapies.

Enrollment: 12 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diffuse Large B-Cell Lymphoma or Follicular lymphoma, previously identified as CD19+
2. Previously treated on UPCC13413/ NCT02030834 with CTL019/CTL119, with historical manufactured product available at Penn for reinfusion
3. Previous complete response to CAR T-cells with a duration ≥ 6 months (defined as 168 days)
4. No available curative treatment options (such as autologous or allogeneic HSCT) with limited prognosis (several months to < 2 year survival) with currently available therapies.
5. Age ≥18 years
6. Creatinine < 1.6 mg/dL
7. ALT/AST < 3x upper limit of normal
8. Bilirubin < 2.0 mg/dL, unless subject has Gilbert's Syndrome (≤3.0 mg/dL)
9. Measurable or assessable disease according to the "Revised Response Criteria for Malignant Lymphoma" (Cheson et al., J. Clin. Onc., 2007)88. Patients in complete remission with no evidence of disease are not eligible.
10. Performance status (ECOG) 0 or 1.
11. Left Ventricle Ejection Fraction (LVEF) > 40% confirmed by ECHO/MUGA
12. Agree to contraceptive requirements outlined in Section 4.3.
13. Provide written informed consent.

Exclusion criteria

1. Uncontrolled active infection.
2. Active hepatitis B or hepatitis C infection.
3. Any uncontrolled active medical disorder that would preclude participation as outlined.
4. Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 1).
5. HIV infection.
6. Patients with active CNS involvement by malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was >4 weeks before enrollment
7. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Retreatment with CTL019/CTL119

Experimental group

Description:

All subjects will receive retreatment with CTL019/CTL119 and be followed per the schedule of procedures.

Treatment:

Drug: CD19 redirected autologous T cells (CTL019 or CTL119 cells)