B Acute Lymphoblastic LeukemiaPhase 1NCT02968472
A Phase I Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Leukemia
A Phase 1 study testing prophylactic 4SCAR19 cells in people with B Acute Lymphoblastic Leukemia, run by The First People's Hospital of Yunnan at 1 site in China.
Trial summary
A chimeric antigen receptor gene-modified T cells (CART: 4SCAR19)by targeted the CD19 (cluster of differentiation antigen 19), treat patients with CD19 positive malignant B cells tumor, assess treatment safety, and observe therapeutic effects. Read more about this study
- Who is it for?
- Ages 6 months and older
- Conditions the study is for
- B Acute Lymphoblastic Leukemia
- What is being tested?
- prophylactic 4SCAR19 cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Mar 2015to May 2019
- 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 6 months and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients aged more than 6 months.
- the immune phenotype analysis of patients with malignant B cell surface expression CD19 molecules.
- the Karnofsky performance status score over 80 points, is expected to patients survival time is more than 3 months.
- the important viscera function meet: heart ultrasound tip heart ejection fraction 50% or higher, electrocardiogram (ecg) not seen obvious abnormality;The blood oxygen saturation 90% or higher;Creatinine 2.5 times normal range or less; aspartate aminotransferase and aspartate aminotransferase3 times normal range or less, total bilirubin of 2.0 mg/dl or less.
- or greater Hgb 80 g/L.
- no contraindications to solid and cell separation
- the patient and family to have a strong willingness to participate in clinical trials, and are willing to bear all the consequence caused by the test failed, and sign the informed consent.
- the panel discussion, combined with patient general condition, think the benefit is greater than the risks involved in the clinical trials.
Who cannot join
- accompanied with other active disease, the treatment is difficult to correct.
- bacteria, fungus, or virus infection, unable to control.
- people living with HIV.
- active hepatitis B virus and hepatitis C virus infection.
- of pregnancy and nursing mothers.
- before entering the test of the use of glucocorticoid systemic treatment within a week.
- confirmed before used CAR - but invalid patients treated T cells, after in the physical examination, experts discuss confirmed by a team doesn't fit in the CAR again - T treatment.Before used gene therapy method.
- the researchers believe that might increase risk subjects or interfere with the test results of any situation.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
First people's hospital of Yunnan province
Kunming, Yunnan, NCT650000
About this study
Official title: Single Center, Open, Phase I Clinical Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Leukemia
A chimeric antigen receptor gene-modified T cells (CART: 4SCAR19)by targeted the CD19 (cluster of differentiation antigen 19), treat patients with CD19 positive malignant B cells tumor, assess treatment safety, and observe therapeutic effects. At the same time,the change process of the CART and residual tumor status of the patient are observe dynamically， which summarizes the best therapeutic effect.
- Conditions
- B Acute Lymphoblastic Leukemia
- Being tested
- prophylactic 4SCAR19 cells
- Keywords
- 4s CAR-T19, B cell leukemia, B-ALL
- Medical subject headings
- Burkitt Lymphoma, Leukemia, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prophylactic 4SCAR19 cellsGenetic
Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19
| Study group | Role | What they receive |
|---|---|---|
| prophylactic 4SCAR19 cells | Experimental | Patients who have relapsed and refractory B cell leukemia after chemotherapy will be treated prophylactically with CD19-specific gene-engineered T cells. Receives: Genetic: prophylactic 4SCAR19 cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.
Safety of fourth generation anti CD19 CAR-T cells in patients with relapsed and refractory B-ALL - Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.
Measured: 24 weeks
Secondary outcomes (1)
Anti tumor activity of fourth generation anti CD19 CAR-T cells in patients with relapsed or refractory B-ALL (B cell acute lymphoblastic leukemia)
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study startMar 2015
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Yunnan
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Geno-Immune Medical Institute
- Responsible party
- Principal investigator, Xun Lai, The First People's Hospital of Yunnan
- Investigators
- Huang Jianzhang, Doctor, Study chair, Shenzhen immune gene therapy research institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968472
- Sponsor's protocol ID
- LXUN
- Status last verified
- Nov 2016
- First submitted
- 16 Nov 2016
- Last updated
- 18 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Lai X, Sun YY, Chang LJ, Ma YR, Gu XZ, Yao XM, Nie B, Wen Y, Zhang XM, Jiang YX, Yang H, Yu LQ, Fang MJ, Wang L, Yuan Bo X. Could cytokine release syndrome induce acute myelofibrosis in CD19 chimeric antigen receptor T cells therapy? Bioengineered. 2020 Dec;11(1):824-828. doi: 10.1080/21655979.2020.1791597.
PubMed 32772769
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Open, Phase I Clinical Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Leukemia
- ClinicalTrials.gov ID
- NCT02968472
- Acronym / sponsor ID
- LXUN
- Conditions
- B Acute Lymphoblastic Leukemia
- Keywords
- 4s CAR-T19, B cell leukemia, B-ALL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First People's Hospital of YunnanUniversity, hospital or other
- Collaborators
- Shenzhen Geno-Immune Medical Institute
- Study start
- Mar 2015
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 18 Nov 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.
A chimeric antigen receptor gene-modified T cells (CART: 4SCAR19)by targeted the CD19 (cluster of differentiation antigen 19), treat patients with CD19 positive malignant B cells tumor, assess treatment safety, and observe therapeutic effects. At the same time,the change process of the CART and residual tumor status of the patient are observe dynamically， which summarizes the best therapeutic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| prophylactic 4SCAR19 cells | Experimental | Genetic: prophylactic 4SCAR19 cellsPatients who have relapsed and refractory B cell leukemia after chemotherapy will be treated prophylactically with CD19-specific gene-engineered T cells. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- patients aged more than 6 months.
- the immune phenotype analysis of patients with malignant B cell surface expression CD19 molecules.
- the Karnofsky performance status score over 80 points, is expected to patients survival time is more than 3 months.
- the important viscera function meet: heart ultrasound tip heart ejection fraction 50% or higher, electrocardiogram (ecg) not seen obvious abnormality;The blood oxygen saturation 90% or higher;Creatinine 2.5 times normal range or less; aspartate aminotransferase and aspartate aminotransferase3 times normal range or less, total bilirubin of 2.0 mg/dl or less.
- or greater Hgb 80 g/L.
Key exclusion criteria (8 listed)
- accompanied with other active disease, the treatment is difficult to correct.
- bacteria, fungus, or virus infection, unable to control.
- people living with HIV.
- active hepatitis B virus and hepatitis C virus infection.
- of pregnancy and nursing mothers.
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 |
|---|---|---|
| prophylactic 4SCAR19 cellsAutologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19 | Genetic | prophylactic 4SCAR19 cells |
Primary outcome
Safety Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.
Time frame: 24 weeks
Safety of fourth generation anti CD19 CAR-T cells in patients with relapsed and refractory B-ALL - Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells.
1 secondary outcome
Anti tumor activity of fourth generation anti CD19 CAR-T cells in patients with relapsed or refractory B-ALL (B cell acute lymphoblastic leukemia)
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2016.
- Derived from this study: PubMed 32772769Lai X, Sun YY, Chang LJ, Ma YR, Gu XZ, Yao XM, Nie B, Wen Y, Zhang XM, Jiang YX, Yang H, Yu LQ, Fang MJ, Wang L, Yuan Bo X. Could cytokine release syndrome induce acute myelofibrosis in CD19 chimeric antigen receptor T cells therapy? Bioengineered. 2020 Dec;11(1):824-828. doi: 10.1080/21655979.2020.1791597.
- Individual participant dataSharing planned: Undecided
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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.
Huang Jianzhang, Doctor study chair
Shenzhen immune gene therapy research institute
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 prophylactic 4SCAR19 cells in people with B Acute Lymphoblastic Leukemia, run by The First People's Hospital of Yunnan 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 8 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 18 Nov 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lai Xun, Doctor (13577096609, 1729112214@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Using CTCAE 4 standard to evaluate the level of adverse events after receiving the cells. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02968472, which also lists 1 linked publication.
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 18 Nov 2016.