Retreatment With CTL019/CTL119
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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 : March 21, 2022
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Condition or disease | Intervention/treatment | Phase |
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Lymphoma, B-Cell | Drug: CD19 redirected autologous T cells (CTL019 or CTL119 cells) | Phase 1 |
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 : | July 2022 |
Estimated Primary Completion Date : | July 2027 |
Estimated Study Completion Date : | July 2027 |

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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diffuse Large B-Cell Lymphoma or Follicular lymphoma, previously identified as CD19+
- Previously treated on UPCC13413/ NCT02030834 with CTL019/CTL119, with historical manufactured product available at Penn for reinfusion
- Previous complete response to CAR T-cells with a duration ≥ 6 months (defined as 168 days)
- No available curative treatment options (such as autologous or allogeneic HSCT) with limited prognosis (several months to < 2 year survival) with currently available therapies.
- Age ≥18 years
- Creatinine < 1.6 mg/dL
- ALT/AST < 3x upper limit of normal
- Bilirubin < 2.0 mg/dL, unless subject has Gilbert's Syndrome (≤3.0 mg/dL)
- 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.
- Performance status (ECOG) 0 or 1.
- Left Ventricle Ejection Fraction (LVEF) > 40% confirmed by ECHO/MUGA
- Agree to contraceptive requirements outlined in Section 4.3.
- Provide written informed consent.
Exclusion Criteria:
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- Any uncontrolled active medical disorder that would preclude participation as outlined.
- Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 1).
- HIV infection.
- 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
- Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system.

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
Contact: Stephen J Schuster, MD | 215.614.1846 | schustes@pennmedicine.upenn.edu | |
Contact: Emerging Medicine | 855-216-0098 | PennCancerTrials@emergingmed.com |
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 |
Principal Investigator: | Stephen J Schuster | University of Pennsylvania |
Responsible Party: | 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: | March 21, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
CTL019 CTL119 CAR T-cell CART |
Lymphoma Lymphoma, B-Cell Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |