Retreatment With CTL019/CTL119

NCT ID: NCT04419909

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-05-31
• Study Completion Date: 2028-07-31

Brief Summary

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

Detailed 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.

Conditions

Lymphoma, B-Cell

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Retreatment with CTL019/CTL119

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

Group Type: EXPERIMENTAL

CD19 redirected autologous T cells (CTL019 or CTL119 cells)

Intervention Type: DRUG

Retreatment with CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19 cells) or huCD19-directed Chimeric Antigen Receptor-modified T Cells (huCART19 cells) in subjects with late relapse of B-cell lymphomas.

Interventions

CD19 redirected autologous T cells (CTL019 or CTL119 cells)

Retreatment with CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19 cells) or huCD19-directed Chimeric Antigen Receptor-modified T Cells (huCART19 cells) in subjects with late relapse of B-cell lymphomas.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen J Schuster

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Central Contacts

Stephen J Schuster, MD

Role: CONTACT

schustes@pennmedicine.upenn.edu

215.614.1846

Emerging Medicine

Role: CONTACT

PennCancerTrials@careboxhealth.com

855-216-0098

Facility Contacts

Stephen J Schuster, MD

Role: primary

PennCancerTrials@careboxhealth.com

855-216-0098

Emerging Medicine

Role: backup

PennCancerTrials@careboxhealth.com

855-216-0098

Other Identifiers

834286

Identifier Type: OTHER

Identifier Source: secondary_id

UPCC 40419

Identifier Type: -

Identifier Source: org_study_id