B-cell Acute Lymphoblastic LeukemiaPhase 1NCT03671460
CD19 CAR-T Cells for Patients With Relapse and Refractory CD19+ B-ALL.
A Phase 1 study testing CD19 CAR-T cells in people with B-cell Acute Lymphoblastic Leukemia, run by Tianjin Mycure Medical Technology Co., Ltd at 1 site in China.
Trial summary
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL). Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia
- What is being tested?
- CD19 CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 7 Sep 2018to 1 Jan 2021
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- More than 1 year;
- CD19 positive B-cell acute lymphoblastic leukemia;
- Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ECG; blood oxygen saturation ≥90%; creatinine clearance calculated by Cockcroft-Gault formula ≥40ml/min; ALT and AST≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / L.
- Expected to survive for more than 3 months;
- Informed consent is signed by a subject or his lineal relation.
Who cannot join
- Recent or current use of glucocorticoid or other immunosuppressor;
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- Has a graft-versus-host response and requires the use of immunosuppressants；
- Drug uncontrollable central nervous system leukemia；
- Pregnant or lactating female；
- The patient did not agree to use effective contraception during the treatment period and for the following 1 year；
- A history of other malignant tumors;
- The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hebei Yanda Ludaopei Hospital
Langfang, Hebei, 065000
Peihua Lu, MD, PhD, 18611636172, peihua_lu@126.com
About this study
Official title: Phase I Study of the Safety and Efficacy of CD19 CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
Read the detailed description
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 CD19+ B-cell relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL) patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-ALL.
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Being tested
- CD19 CAR-T cells
- Keywords
- B-cell acute lymphoblastic leukemia, CD19 CAR-T
- 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
T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.
| Study group | Role | What they receive |
|---|---|---|
| CD19-CAR-T Cells | Experimental | Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose. Receives: Biological: CD19 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of adverse events
Percentage of participants with adverse events
Measured: 6 months
Secondary outcomes (2)
complete remission rate
The percentage of participants who achieved complete remission (CR) over all participants (CRR).
Measured: 6 months
objective remission rate
The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start7 Sep 2018 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell 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
- Model description
- single-center, open-label, nonrandomized, no control, prospective clinical trial
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Mycure Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peihua Lu, PhD,MD, Principal investigator, Hebei Yanda Ludaopei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03671460
- Sponsor's protocol ID
- TianjinMycure-LDP-CD19 CAR-T
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We don't decide when to share IPD and what will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of the Safety and Efficacy of CD19 CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)
- ClinicalTrials.gov ID
- NCT03671460
- Acronym / sponsor ID
- TianjinMycure-LDP-CD19 CAR-T
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Keywords
- B-cell acute lymphoblastic leukemia, CD19 CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Tianjin Mycure Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 7 Sep 2018 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 14 Sep 2018 (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 is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
Detailed description
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 CD19+ B-cell relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL) patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-ALL.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- single-center, open-label, nonrandomized, no control, prospective clinical trial
| Arm | Type | Receives |
|---|---|---|
| CD19-CAR-T Cells | Experimental | Biological: CD19 CAR-T cellsSubjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- More than 1 year;
- CD19 positive B-cell acute lymphoblastic leukemia;
- Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ECG; blood oxygen saturation ≥90%; creatinine clearance calculated by Cockcroft-Gault formula ≥40ml/min; ALT and AST≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / L.
- Expected to survive for more than 3 months;
- Informed consent is signed by a subject or his lineal relation.
Key exclusion criteria (8 listed)
- Recent or current use of glucocorticoid or other immunosuppressor;
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive;
- Has a graft-versus-host response and requires the use of immunosuppressants；
- Drug uncontrollable central nervous system leukemia；
- Pregnant or lactating female；
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 cellsT cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration. | Biological | CD19-CAR-T Cells |
Primary outcome
Percentage of adverse events
Time frame: 6 months
Percentage of participants with adverse events
2 secondary outcomes
complete remission rate
Time frame: 6 months
objective remission rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
- Individual participant dataSharing planned: Undecided. We don't decide when to share IPD and what will be shared.
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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.
Peihua Lu, PhD,MD principal investigator
Hebei Yanda Ludaopei Hospital
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 Lymphoblastic Leukemia, run by Tianjin Mycure Medical 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 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 14 Sep 2018. 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 Chaoting Zhang, PhD (86-010-88196768, zhangchaoting1@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of adverse events (time frame: 6 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 14 Sep 2018.