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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02935543
Other study ID # UPCC39416, 825668
Secondary ID
Status Terminated
Phase Phase 2
First received
Last updated
Start date October 2016
Est. completion date December 12, 2018

Study information

Verified date January 2020
Source University of Pennsylvania
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a single center, single arm, open-label phase 2 study to determine the efficacy of autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ/4-1BB) co-stimulatory domains (referred to as "CART19" cells) in adults with minimal residual disease (MRD) during upfront treatment for CD19+ acute lymphoblastic leukemia.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date December 12, 2018
Est. primary completion date December 12, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Patients with CD19+, B cell Acute Lymphoblastic Leukemia (B-ALL) who have 0.01%=MRD<10% during upfront treatment 2. Patients must be within 18 months of initial ALL diagnosis 3. Age =18 years 4. Adequate organ function defined as: 1. Creatinine = grade 2 2. ALT/AST =3x upper limit of normal range for age 3. Direct bilirubin =2.0 mg/dl 4. Adequate pulmonary function defined as = grade 2 dyspnea and = grade 2 hypoxia 5. Cardiac Left Ventricle Ejection Fraction (LVEF) = 40% confirmed by ECHO/MUGA 5. Patients with CNS3 disease will be eligible if CNS disease is responsive to therapy. 6. Expression of CD19 on leukemic blasts demonstrated by flow cytometry or immunohistochemistry of bone marrow or peripheral blood 7. Adequate performance status defined as ECOG Performance Status 0 or 1 8. Provides written informed consent 9. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol Exclusion Criteria: 1. Active, uncontrolled infection 2. Active hepatitis B or hepatitis C 3. HIV Infection 4. Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 2) 5. Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment. 6. Pregnant or nursing (lactating) women 7. Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
CART 19
CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Subjects will receive 1-5 x 10^8 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction: 1-5x10^7 CART19 cells, Day 2, 30% fraction: 3x10^7-1.5x10^8 CART19 cells, Day 3, 60% fraction: 6x10^7-3x10^8 CART19 cells

Locations

Country Name City State
United States University of Pennsylvania Philadelphia Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Incidence of Conversion of Minimal Residual Disease (MRD) to <0.01% The incidence of conversion of minimal residual disease (MRD) to <0.01% after CART19 therapy in patients with MRD+ ALL during upfront treatment Day 28
Secondary Best Overall Survival (OS) Overall survival (OS) is defined as the time from the date of the first CART19 infusion to the date of death due to any reason. one year
Secondary Duration of Remission (DOR) Duration of remission (DOR) is defined as the duration from the date when the response criteria of CR or CRi is first met to the date of relapse or death due to ALL. one year
Secondary Relapse Free Survival (RFS) Relapse free survival (RFS) is defined as the duration between the date when the response criteria of CR or CRi is first met to the date of relapse or death due to any cause. one year
Secondary Event Free Survival (EFS) Event free survival (EFS) is defined as the time from start of the first CART19 infusion to the earliest of the following:
Death from any cause Relapse
Treatment failure: Defined as no response in the study and discontinuation from the study due to any of the following reasons:
Adverse event(s)
Abnormal laboratory value(s)
Abnormal test procedure results
New cancer therapy (excluding HSCT when performed in CR or CRi)
one year
Secondary Percentage of Manufacturing Products That do Not Meet Release Criteria for Vector Transduction Efficiency, T Cell Product Purity, Viability, Sterility or Due to Tumor Contamination. Percentage of manufacturing products that do not meet release criteria for vector transduction efficiency, T cell product purity, viability, sterility or due to tumor contamination. prior to day 1
Secondary Safety and Tolerability of CART19: Frequency and Severity of Adverse Events, Including, But Not Limited to, Cytokine Release Syndrome (CRS) and Macrophage Activation Syndrome (MAS). Frequency and severity of adverse events, including, but not limited to, cytokine release syndrome (CRS) and macrophage activation syndrome (MAS). one year
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