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Retreatment With CTL019/CTL119

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04419909
Recruitment Status : Not yet recruiting
First Posted : June 9, 2020
Last Update Posted : August 25, 2020
Sponsor:
Information provided by (Responsible Party):
Abramson Cancer Center of the University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Lymphoma, B-Cell Drug: CD19 redirected autologous T cells (CTL019 or CTL119 cells) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Retreatment With CTL019/CTL119 in Patients With Late Relapse of B-Cell Lymphomas
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : July 2027
Estimated Study Completion Date : July 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: Retreatment with CTL019/CTL119
All subjects will receive retreatment with CTL019/CTL119 and be followed per the schedule of procedures.
Drug: 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.




Primary Outcome Measures :
  1. 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 of retreatment with CTL019/CTL119 as measured by treatment-related events


Secondary Outcome Measures :
  1. Overall response rate using Cheson 2007 criteria [ Time Frame: Month 3 post-infusion ]
    Efficacy of retreatment with CTL019/CTL119 as measured by ORR by Cheson 2007 definitions at 3 months



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04419909


Contacts
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Contact: Stephen J Schuster, MD 215.614.1846 schustes@pennmedicine.upenn.edu
Contact: Emerging Medicine 855-216-0098 PennCancerTrials@emergingmed.com

Locations
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United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Contact: Stephen J Schuster, MD    855-216-0098    PennCancerTrials@emergingmed.com   
Contact: Emerging Medicine    855-216-0098    PennCancerTrials@emergingmed.com   
Sponsors and Collaborators
Abramson Cancer Center of the University of Pennsylvania
Investigators
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Principal Investigator: Stephen J Schuster University of Pennsylvania
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Responsible Party: Abramson Cancer Center of the University of Pennsylvania
ClinicalTrials.gov Identifier: NCT04419909    
Other Study ID Numbers: UPCC 40419
834286 ( Other Identifier: University of Pennsylvania Institutional Review Board )
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: August 25, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abramson Cancer Center of the University of Pennsylvania:
CTL019
CTL119
CAR T-cell
CART
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, B-Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin