Acute LeukemiaPhase 1/2NCT03232619
CD19-CART Treatment for ALL
A Phase 1/2 study testing CD19 CART in people with Acute Leukemia, run by Bioray Laboratories at 1 site in China.
Trial summary
This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of refractory or recurrent ALL. Read more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- CD19 CART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2018to 15 Sep 2020
- 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 6 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- previously identified as CD19+ ALL.
- ALL patients not eligible for allogeneic SCT or relapse after allogeneic SCT.
- Expected survival >12W.
- Creatinine < 2.5 mg/dl.
- Alanine transaminase (ALT)/Aspartate Aminotransferase (AST) < 3x normal
- Bilirubin <2.0 mg/dl
- Voluntary informed consent is given.
Who cannot join
- Pregnant or lactating women.
- 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.
- Any uncontrolled active medical disorder that would preclude participation as outlined.
- HIV infection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Efficacy Evaluation of CD19-CART Treatment for Refractory or Recurrent ALL
This study aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of refractory or recurrent ALL.
Read the detailed description
Chimeric antigen receptor T cell (CART) is a kind of engineered immunotherapy by transferring an artificial antigen binding receptor and also intercellular co-stimulating molecules into T cells. This kind of engineered T cells gains the ability to recognize antigen specific tumor cells and initiate the killing process in a HLA-independent way. CD19 is the specific cellular marker of B lineage acute leukemia (B-ALL), thus CD19-CART will be efficient in treating B lineage ALL. The investigators have constructed two kinds of CD19-CART. One is equipped with a murine CD19 scFv (single-chain variable fragmentt), while the other with a humanized scFv. This study aims to evaluate the safety and efficacy of both murine and humanized CD19-CART in treating refractory or recurrent ALL.
- Conditions
- Acute Leukemia
- Being tested
- CD19 CART
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19 CARTBiological
Patients will get one course of CART treatment with the dose of 0.5-5*10~6/KgBW.
| Study group | Role | What they receive |
|---|---|---|
| CD19-CART with a murine scFv | Experimental | All enrolled patients in this arm will receive CD19-CART with a murine scFv. Receives: Biological: CD19 CART |
| humanized CD19-CART | Experimental | All enrolled patients in this arm will receive humanized CD19-CART. Receives: Biological: CD19 CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological assessment
Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.
Measured: Month1 to Month12
Secondary outcomes (1)
The safety of CART immunotherapy
After CAR-T cell infusion,we will observe the potential adverse events, especially Cytokine Release Syndrome (CRS) and neurotoxicity
Measured: Day 1 to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start1 Aug 2018
- Primary completion6 May 2020
- Study completion15 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled patients will receive CD19-CART cell immunotherapy.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bioray Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Second Xiangya Hospital of Central South University
- Responsible party
- Sponsor
- Investigators
- Yunxiao Xu, MD, Principal investigator, Second Xiangya Hospital of Central South University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232619
- Sponsor's protocol ID
- SHBYCL001
- Status last verified
- Sep 2020
- First submitted
- 20 Jul 2017
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Evaluation of CD19-CART Treatment for Refractory or Recurrent ALL
- ClinicalTrials.gov ID
- NCT03232619
- Acronym / sponsor ID
- SHBYCL001
- Conditions
- Acute Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bioray LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- Second Xiangya Hospital of Central South University
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 6 May 2020 (actual)
- Study completion
- 15 Sep 2020 (actual)
- First posted
- 28 Jul 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 aims to evaluate the safety and efficacy of a novel CD19-CART in the treatment of refractory or recurrent ALL.
Detailed description
Chimeric antigen receptor T cell (CART) is a kind of engineered immunotherapy by transferring an artificial antigen binding receptor and also intercellular co-stimulating molecules into T cells. This kind of engineered T cells gains the ability to recognize antigen specific tumor cells and initiate the killing process in a HLA-independent way. CD19 is the specific cellular marker of B lineage acute leukemia (B-ALL), thus CD19-CART will be efficient in treating B lineage ALL. The investigators have constructed two kinds of CD19-CART. One is equipped with a murine CD19 scFv (single-chain variable fragmentt), while the other with a humanized scFv. This study aims to evaluate the safety and efficacy of both murine and humanized CD19-CART in treating refractory or recurrent ALL.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Enrolled patients will receive CD19-CART cell immunotherapy.
| Arm | Type | Receives |
|---|---|---|
| CD19-CART with a murine scFv | Experimental | Biological: CD19 CARTAll enrolled patients in this arm will receive CD19-CART with a murine scFv. |
| humanized CD19-CART | Experimental | Biological: CD19 CARTAll enrolled patients in this arm will receive humanized CD19-CART. |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- previously identified as CD19+ ALL.
- ALL patients not eligible for allogeneic SCT or relapse after allogeneic SCT.
- Expected survival >12W.
- Creatinine < 2.5 mg/dl.
- Alanine transaminase (ALT)/Aspartate Aminotransferase (AST) < 3x normal
Key exclusion criteria (7 listed)
- Pregnant or lactating women.
- 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 |
|---|---|---|
| CD19 CARTPatients will get one course of CART treatment with the dose of 0.5-5*10~6/KgBW. | Biological | CD19-CART with a murine scFv, humanized CD19-CART |
Primary outcome
Radiological assessment
Time frame: Month1 to Month12
Radiological assessment of the therapeutic effect by systemic or local computed Tomography(CT) or positron emission tomography scan.
1 secondary outcome
The safety of CART immunotherapy
Time frame: Day 1 to Week 4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
- 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.
Yunxiao Xu, MD principal investigator
Second Xiangya Hospital of Central South University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD19 CART in people with Acute Leukemia, run by Bioray Laboratories 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 7 inclusion and 7 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: finished, as of the sponsor's last update on 22 Sep 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 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Radiological assessment (time frame: Month1 to Month12). 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 22 Sep 2020.