B-cell Acute Lymphocytic LeukemiaPhase 1NCT03064269
CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
A Phase 1 study testing CD19 CAR-T cells in people with B-cell Acute Lymphocytic Leukemia, run by Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd at 1 site in China.
Trial summary
This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia. Read more about this study
- Who is it for?
- Ages 10 to 60 years
- Conditions the study is for
- B-cell Acute Lymphocytic Leukemia
- What is being tested?
- CD19 CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2017to 31 Dec 2025
- 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 10 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia
- ALT/ AST 《 3x normal
- Creatinine 《 3x normal
- Age:10-60.
- Signed informed consent
Who cannot join
- Active hepatitis B , hepatitis C or HIV infection
- Uncontrolled active infection
- Pregnancy or breast-feeding women
- Survival less than four weeks
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Soochow University
Suzhou
Sheng-Li Xue, Ph.D, 86-13328008851, slxue@suda.edu.cn
About this study
This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.
Read the detailed description
CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells
- Conditions
- B-cell Acute Lymphocytic Leukemia
- Being tested
- CD19 CAR-T cells
- Keywords
- CNS B cell acute lymphocytic leukemia
- Medical subject headings
- Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 CAR-T cellsBiological
CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | CD19 CAR-T cells treated central nervous system B-cell acute lymphocytic leukemia. Receives: Biological: CD19 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The complete remission (CR) rate
The safety of the humanized CD19 CAR-T cells treatment will be evalated and the maximum tolerated dose will be determined
Measured: Participants will be followed for the duration of the treatment, an expected average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study start1 Mar 2017
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (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-cell Acute Lymphocytic 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Responsible party
- Sponsor
- Investigators
- Sheng-Li Xue, Ph.D, Principal investigator, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064269
- Sponsor's protocol ID
- UnicarTherapy
- Status last verified
- Nov 2023
- First submitted
- 18 Feb 2017
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen LY, Kang LQ, Zhou HX, Gao HQ, Zhu XF, Xu N, Yu L, Wu DP, Xue SL, Sun AN. Successful application of anti-CD19 CAR-T therapy with IL-6 knocking down to patients with central nervous system B-cell acute lymphocytic leukemia. Transl Oncol. 2020 Nov;13(11):100838. doi: 10.1016/j.tranon.2020.100838. Epub 2020 Jul 31.
PubMed 32745961
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAR-T Therapy for Central Nervous System B-cell Acute Lymphocytic Leukemia
- ClinicalTrials.gov ID
- NCT03064269
- Acronym / sponsor ID
- UnicarTherapy
- Conditions
- B-cell Acute Lymphocytic Leukemia
- Keywords
- CNS B cell acute lymphocytic leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Shanghai Unicar-Therapy Bio-medicine Technology Co.,LtdIndustry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Soochow University
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 27 Feb 2017 (actual)
- 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.
This study will evaluates the safety and efficacy of Chimeric antigen receptor T cells (CAR-T) in treating central nervous system B-cell acute lymphocytic leukemia.
Detailed description
CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells
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: CD19 CAR-T cellsCD19 CAR-T cells treated central nervous system B-cell acute lymphocytic leukemia. |
Who may qualify
- Ages
- 10 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Patients with CD19 positive central nervous system B-cell acute lymphocytic leukemia
- ALT/ AST 《 3x normal
- Creatinine 《 3x normal
- Age:10-60.
- Signed informed consent
Key exclusion criteria (4 listed)
- Active hepatitis B , hepatitis C or HIV infection
- Uncontrolled active infection
- Pregnancy or breast-feeding women
- Survival less than four weeks
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 |
|---|---|---|
| CD19 CAR-T cellsCNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells | Biological | Arm 1 |
Primary outcome
The complete remission (CR) rate
Time frame: Participants will be followed for the duration of the treatment, an expected average of 12 months
The safety of the humanized CD19 CAR-T cells treatment will be evalated and the maximum tolerated dose will be determined
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Derived from this study: PubMed 32745961Chen LY, Kang LQ, Zhou HX, Gao HQ, Zhu XF, Xu N, Yu L, Wu DP, Xue SL, Sun AN. Successful application of anti-CD19 CAR-T therapy with IL-6 knocking down to patients with central nervous system B-cell acute lymphocytic leukemia. Transl Oncol. 2020 Nov;13(11):100838. doi: 10.1016/j.tranon.2020.100838. Epub 2020 Jul 31.
- Individual participant dataSharing planned: No
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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.
Sheng-Li Xue, Ph.D principal investigator
The First Affiliated Hospital of Soochow University
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 CD19 CAR-T cells in people with B-cell Acute Lymphocytic Leukemia, run by Shanghai Unicar-Therapy Bio-medicine Technology 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 5 inclusion and 4 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 29 Nov 2023. 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 Sheng-Li Xue, MD (86-13328008851, slxue@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The complete remission (CR) rate (time frame: Participants will be followed for the duration of the treatment, an expected average of 12 months). 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 NCT03064269, 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 29 Nov 2023.