A Phase 2 interventional study of CART 19 in Leukemia, Acute Lymphoblastic, sponsored by University of Pennsylvania. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-22.
Sponsored by University of Pennsylvania · Phase 2, Interventional, and Treatment
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's enrollment of 1 is below the median of 38 across 4,247 interventional studies indexed under Leukemia.
Browse Leukemia studies →University of Pennsylvania is the lead sponsor of 1,635 studies on the registry; 239 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 104 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adequate organ function defined as:
Exclusion Criteria:
CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion.
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
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
Time frame: Day 28
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.
Time frame: one year
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.
Time frame: one year
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.
Time frame: one year
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)
Time frame: one year
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.
Time frame: prior to day 1
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).
Time frame: one year
| Milestone | CART19 |
|---|---|
| Started | 1 |
| Completed | 1 |
| Not completed | 0 |
The incidence of conversion of minimal residual disease (MRD) to \<0.01% after CART19 therapy in patients with MRD+ ALL during upfront treatment
| Participants | CART19 |
|---|---|
| The Incidence of Conversion of Minimal Residual Disease (MRD) to <0.01% | 0 |
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
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)
No measurements were reported for this outcome.
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 products | CART19 |
|---|---|
| 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. | 0 |
Frequency and severity of adverse events, including, but not limited to, cytokine release syndrome (CRS) and macrophage activation syndrome (MAS).
| percentage of participants | CART19 |
|---|---|
| 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). | 100 |
Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| CART19 | 1/1 (100%) | 1/1 (100%) | 0/1 (0%) |
| Event | CART19 |
|---|---|
| gastric necrosisGastrointestinal disorders | 1/1 |
| parathesiasNervous system disorders | 1/1 |
| encephalopathyNervous system disorders | 1/1 |
| Age, Categorical(Participants) | CART19 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | CART19 |
|---|---|
| Female | 1 |
| Male | 0 |
| Race (NIH/OMB)(Participants) | CART19 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 0 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | CART19 |
|---|---|
| United States | 1 |
Documents are hosted by the registry — open the source record to download them.
This study is terminated, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Pennsylvania