Acute Lymphocytic LeukemiaPhase 1NCT01551043
Allo CART-19 Protocol
A Phase 1 study testing CART-19 in people with Acute Lymphocytic Leukemia, run by University of Pennsylvania at 1 site in United States.
Trial summary
The primary objective is to determine the safety and survival of the redirected allogeneic T cells transduced with the anti-CD19 lentiviral vector (referred to as CART-19 cells). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphocytic Leukemia
- What is being tested?
- CART-19
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jun 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- CD19+ ALL relapsed after allogeneic SCT.
- No active GVHD and off immunosuppression for greater than or equal to 4 weeks.
- Age greater than or equal to 18 years.
- Creatinine less than or equal to2.5 mg/dl.
- ALT/AST less than or equal to3x normal
- Bilirubin less than or equal to2.0 mg/dl
- Donor is available and is able to undergo apheresis. A separate donor consent process and form is described below.
- Voluntary informed consent is given.
Who cannot join
- Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- Previously treatment with any gene therapy products.
- Feasibility assessment during screening demonstrates less than 30% transduction of target lymphocytes, or insufficient expansion ( less than 5-fold) in response to CD3/CD28 costimulation..
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- Any uncontrolled active medical disorder that would preclude participation as outlined.
- HIV infection.
- Patients with active CNS involvement with leukemia. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was greater than or equal to 4 weeks before enrollment
- Patients with active GVHD or requiring immune suppression.
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Pilot Study of Donor Lymphocyte Infusions Using Donor T Cells Engineered to Contain Anti-CD19 Attached To TCR And 4-1BB Signaling Domains in Patients With Relapsed CD19+ All After Allogeneic Stem Cell Transplantation
The primary objective is to determine the safety and survival of the redirected allogeneic T cells transduced with the anti-CD19 lentiviral vector (referred to as CART-19 cells).
Read the detailed description
The investigators propose an open label, single center, pilot study to evaluate the safety and tolerability, and persistence of donor lymphocytes engineered to express a chimeric antigen receptor targeting CD19 which is linked to the CD3:4-1BB signaling chains in patients with CD19+ acute lymphoblastic leukemia (ALL). Upon enrollment, donors will undergo leukapheresis and patients will undergo an optional bone marrow/lymph node biopsy approximately four weeks prior to dosing. Between dosing and treatment, patients may undergo an additional chemotherapy treatment depending upon their disease. At dosing, patients will receive redirected donor lymphocytes targeted against CD19 (allo-CART-19 cells). The cell dose will be given as a split infusion over three days to enhance the ability to manage any infusion related toxicity. Patients will be monitored weekly for four weeks. At the end of four weeks, patients will undergo a second leukapheresis and second optional bone marrow/lymph node biopsy. At this point the patient will also undergo restaging. Observation and monitoring of patients will continue on a monthly basis until week 24 post dosing. Annual follow-up for lentiviral vector safety will be carried out for 15 years in accordance with FDA guidelines for retroviral vectors. Ten subjects will be targeted for this study, with an expected rate of drop out of 30% due to disease progression between enrollment and week four post dosing.
- Conditions
- Acute Lymphocytic Leukemia
- Being tested
- CART-19
- Keywords
- adult patients, aged 18, CD19+ ALL relapsed, after allogeneic SCT
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CART-19Biological
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Biological: CART-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Adverse Events
Measured: 26 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2012 (estimated)
- Study startSep 2010
- Primary completionMay 2015
- Study completionJun 2016
Why it stopped: Administrative Reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lymphocytic LeukemiaStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Porter, MD, Principal investigator, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551043
- Sponsor's protocol ID
- UPCC 01410
- Status last verified
- Jul 2020
- First submitted
- 8 Mar 2012
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Donor Lymphocyte Infusions Using Donor T Cells Engineered to Contain Anti-CD19 Attached To TCR And 4-1BB Signaling Domains in Patients With Relapsed CD19+ All After Allogeneic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT01551043
- Acronym / sponsor ID
- UPCC 01410
- Conditions
- Acute Lymphocytic Leukemia
- Keywords
- adult patients, aged 18, CD19+ ALL relapsed, after allogeneic SCT
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative Reasons
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 12 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to determine the safety and survival of the redirected allogeneic T cells transduced with the anti-CD19 lentiviral vector (referred to as CART-19 cells).
Detailed description
The investigators propose an open label, single center, pilot study to evaluate the safety and tolerability, and persistence of donor lymphocytes engineered to express a chimeric antigen receptor targeting CD19 which is linked to the CD3:4-1BB signaling chains in patients with CD19+ acute lymphoblastic leukemia (ALL). Upon enrollment, donors will undergo leukapheresis and patients will undergo an optional bone marrow/lymph node biopsy approximately four weeks prior to dosing. Between dosing and treatment, patients may undergo an additional chemotherapy treatment depending upon their disease. At dosing, patients will receive redirected donor lymphocytes targeted against CD19 (allo-CART-19 cells). The cell dose will be given as a split infusion over three days to enhance the ability to manage any infusion related toxicity. Patients will be monitored weekly for four weeks. At the end of four weeks, patients will undergo a second leukapheresis and second optional bone marrow/lymph node biopsy. At this point the patient will also undergo restaging. Observation and monitoring of patients will continue on a monthly basis until week 24 post dosing. Annual follow-up for lentiviral vector safety will be carried out for 15 years in accordance with FDA guidelines for retroviral vectors. Ten subjects will be targeted for this study, with an expected rate of drop out of 30% due to disease progression between enrollment and week four post dosing.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: CART-19 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- CD19+ ALL relapsed after allogeneic SCT.
- No active GVHD and off immunosuppression for greater than or equal to 4 weeks.
- Age greater than or equal to 18 years.
- Creatinine less than or equal to2.5 mg/dl.
- ALT/AST less than or equal to3x normal
Key exclusion criteria (10 listed)
- Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
- Uncontrolled active infection.
- Active hepatitis B or hepatitis C infection.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
- Previously treatment with any gene therapy products.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CART-19 | Biological | Arm 1 |
Primary outcome
Number of Adverse Events
Time frame: 26 months
Results and safety
The study was stopped early (reason given: Administrative Reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Porter, MD principal investigator
Abramson Cancer Center at Penn Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CART-19 in people with Acute Lymphocytic Leukemia, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Administrative Reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Adverse Events (time frame: 26 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2020.