Clinical Trials /

Retreatment With CTL019/CTL119

NCT04419909

Description:

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

Related Conditions:
  • Diffuse Large B-Cell Lymphoma
  • Follicular Lymphoma
Recruiting Status:

Not yet recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Retreatment With CTL019/CTL119
  • Official Title: Retreatment With CTL019/CTL119 in Patients With Late Relapse of B-Cell Lymphomas

Clinical Trial IDs

  • ORG STUDY ID: UPCC 40419
  • SECONDARY ID: 834286
  • NCT ID: NCT04419909

Conditions

  • Lymphoma, B-Cell

Interventions

DrugSynonymsArms
CD19 redirected autologous T cells (CTL019 or CTL119 cells)Retreatment with CTL019/CTL119

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Retreatment with CTL019/CTL119ExperimentalAll subjects will receive retreatment with CTL019/CTL119 and be followed per the schedule of procedures.
  • CD19 redirected autologous T cells (CTL019 or CTL119 cells)

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.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time Frame:At time of consent through 1 year after the subject received CTL019/CTL119
Safety Issue:
Description:Safety of retreatment with CTL019/CTL119 as measured by treatment-related events

Secondary Outcome Measures

Measure:Overall response rate using Cheson 2007 criteria
Time Frame:Month 3 post-infusion
Safety Issue:
Description:Efficacy of retreatment with CTL019/CTL119 as measured by ORR by Cheson 2007 definitions at 3 months

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Abramson Cancer Center of the University of Pennsylvania

Trial Keywords

  • CTL019
  • CTL119
  • CAR T-cell
  • CART

Last Updated

June 3, 2020