Acute Lymphocytic LeukemiaPhase 1/2NCT02819583
CAR-T Cell Immunotherapy in CD19 Positive Relapsed or Refractory Leukemia and Lymphoma
A Phase 1/2 study testing PCAR-019 (anti-CD19 CAR-T cells) in people with Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in patients with CD19 positive relapsed or refractory Leukemia and Lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Follicular Lymphoma
- What is being tested?
- PCAR-019 (anti-CD19 CAR-T cells)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Sep 2019
- Phase
- Phase 1/2
- 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
- Male and female subjects with CD19+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled:
- Eligible diseases: Acute lymphocytic leukemia (ALL), Chronic lymphocytic leukemia (CLL), Follicular lymphoma, Mantle cell lymphoma, B-cell prolymphocytic leukemia, and diffuse large cell lymphoma, previously identified as CD19+.
- Patients 18 years of age or older, and must have a life expectancy > 12 weeks.
- Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
- Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis.
- Females of child-bearing potential must have a negative pregnancy test and all subjects must agree to use an effective method of contraception for up to two weeks after the last infusion of CAR T cells.
- Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: White blood cell count (WBC) ≥ 2500c/ml, Platelets ≥ 50×10^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase < 1.5×upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration.
- Ability to give informed consent.
Who cannot join
- The transduction efficiency of the T cells is less than 30% or the amplification of the T cells via artificial antigen presenting cell (aAPC) stimulation is less than 5 times.
- Pregnant or nursing women may not participate.
- Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the time of screening.
- Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
- History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.
- Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
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- Previously treatment with any gene therapy products.
- The existence of unstable or active ulcers or gastrointestinal bleeding.
- Patients need anticoagulant therapy (such as warfarin or heparin).
- Patients need long-term antiplatelet therapy (aspirin at a dose > 300mg/d; clopidogrel at a dose > 75mg/d).
- Patients using fludarabine or cladribine chemotherapy within 3 months prior to leukapheresis.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
PersonGen BioTherapeutics (Suzhou) Co., Ltd.
Suzhou, Jiangsu, 215123
Lin Yang, Ph.D, 86-512-65922190, info@persongen.com
Xingbing Wang, MD
About this study
Official title: Study Evaluating the Efficacy and Safety of PCAR-019 in CD19 Positive Relapsed or Refractory Leukemia and Lymphoma
The purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in patients with CD19 positive relapsed or refractory Leukemia and Lymphoma.
- Conditions
- Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Follicular Lymphoma, Mantle Cell Lymphoma, B-cell Prolymphocytic Leukemia, Diffuse Large Cell Lymphoma
- Being tested
- PCAR-019 (anti-CD19 CAR-T cells)
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Follicular, Lymphoma, Mantle-Cell, Leukemia, Prolymphocytic, B-Cell, Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCAR-019 (anti-CD19 CAR-T cells)Biological
Also called chimeric antigen receptor T cells with specificity for CD19
| Study group | Role | What they receive |
|---|---|---|
| PCAR-019 | Experimental | Enrolled patients will receive PCAR-019 with a novel specific chimeric antigen receptor targeting CD19 antigen by infusion. Receives: Biological: PCAR-019 (anti-CD19 CAR-T cells) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Adverse events attributed to the administration of the anti-CD19 CAR-T cells
Measured: 2 years
Secondary outcomes (1)
Phase II: Objective Response Rate
Measured: Safety follow-up is 100 days from last CAR-T infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study startOct 2016
- Primary completionSep 2018 (estimated)
- Study completionSep 2019 (estimated)
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 PersonGen BioTherapeutics (Suzhou) Co., Ltd.The 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First People's Hospital of Hefei, Hefei Binhu Hospital, Anhui Provincial Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02819583
- Sponsor's protocol ID
- PG-019-001
- Status last verified
- Oct 2016
- First submitted
- 28 Jun 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluating the Efficacy and Safety of PCAR-019 in CD19 Positive Relapsed or Refractory Leukemia and Lymphoma
- ClinicalTrials.gov ID
- NCT02819583
- Acronym / sponsor ID
- PG-019-001
- Conditions
- Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Follicular Lymphoma, Mantle Cell Lymphoma, B-cell Prolymphocytic Leukemia, Diffuse Large Cell Lymphoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- PersonGen BioTherapeutics (Suzhou) Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First People's Hospital of Hefei, Hefei Binhu Hospital, Anhui Provincial Hospital
- Study start
- Oct 2016
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Sep 2019 (estimated)
- First posted
- 30 Jun 2016 (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 purpose of this study is to evaluate the safety and effectiveness of CAR-T cell immunotherapy in patients with CD19 positive relapsed or refractory Leukemia and Lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PCAR-019 | Experimental | Biological: PCAR-019 (anti-CD19 CAR-T cells)Enrolled patients will receive PCAR-019 with a novel specific chimeric antigen receptor targeting CD19 antigen by infusion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female subjects with CD19+ B cell malignancies in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled:
- Eligible diseases: Acute lymphocytic leukemia (ALL), Chronic lymphocytic leukemia (CLL), Follicular lymphoma, Mantle cell lymphoma, B-cell prolymphocytic leukemia, and diffuse large cell lymphoma, previously identified as CD19+.
- Patients 18 years of age or older, and must have a life expectancy > 12 weeks.
- Eastern cooperative oncology group (ECOG) performance status of 0-2 or karnofsky performance status (KPS) score is higher than 60.
- Adequate venous access for apheresis or venous sampling, and no other contraindications for leukapheresis.
Key exclusion criteria (11 listed)
- The transduction efficiency of the T cells is less than 30% or the amplification of the T cells via artificial antigen presenting cell (aAPC) stimulation is less than 5 times.
- Pregnant or nursing women may not participate.
- Active HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at the time of screening.
- Serious illness or medical condition which would not permit the patient to be managed according to the protocol, including active uncontrolled infection, major cardiovascular, coagulation disorders, respiratory or immune system, myocardial infarction, cardiac arrhythmias, obstructive/restrictive pulmonary disease, or psychiatric or emotional disorders.
- History of severe immediate hypersensitivity to any of the agents including cyclophosphamide, fludarabine, or aldesleukin.
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 |
|---|---|---|
| PCAR-019 (anti-CD19 CAR-T cells)Also: chimeric antigen receptor T cells with specificity for CD19 | Biological | PCAR-019 |
Primary outcome
Phase I: Adverse events attributed to the administration of the anti-CD19 CAR-T cells
Time frame: 2 years
1 secondary outcome
Phase II: Objective Response Rate
Time frame: Safety follow-up is 100 days from last CAR-T infusion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing PCAR-019 (anti-CD19 CAR-T cells) in people with Acute Lymphocytic Leukemia and Chronic Lymphocytic Leukemia, run by PersonGen BioTherapeutics (Suzhou) Co., Ltd. at 1 site in China.
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 11 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: status not confirmed, as of the sponsor's last update on 25 Oct 2016. 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 China. 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Yang, Ph.D. (86-512-65922190, info@persongen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Adverse events attributed to the administration of the anti-CD19 CAR-T cells (time frame: 2 years). 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 25 Oct 2016.