B-cell Acute Lymphoblastic Leukemia (B-ALL)Early Phase 1NCT04166838
The Clinical Study of CD19 UCAR-T Cells in Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL)
A Early Phase 1 study testing CD19 UCARTcells in people with B-cell Acute Lymphoblastic Leukemia (B-ALL) and Safety and Efficacy of CD19 UCAR-T Cells, run by Shanghai Longyao Biotechnology Inc., Ltd. at 1 site in China.
Trial summary
This is a single arm, open-label, single center, exploratory clinical study to evaluate the safety and efficacy of CD19 UCAR-T Cells in Patients With CD19+ B-cell acute lymphoblastic leukemia (B-ALL). Read more about this study
- Who is it for?
- Ages 6 to 70 years
- Conditions the study is for
- B-cell Acute Lymphoblastic Leukemia (B-ALL), Safety and Efficacy of CD19 UCAR-T Cells
- What is being tested?
- CD19 UCARTcells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 8 Nov 2019to 8 Nov 2019
- Phase
- Early 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 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Subjects between 6 and 70 years of age, inclusive.
- 2. Subjects diagnosed as relapsed or refractory B cell acute lymphocytic leukemia (B-ALL):
- Relapse as defined by 2nd or greater BM relapse or Any BM relapse after allogeneic SCT, naive lymphocytes in BM≥5%；
- refractory as defined by not achieving a CR after 2 rounds of standard chemotherapy.
- 3. Life expectancy > 12 weeks.
- 4. ECOG score between 0 and 1.
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- 5. Liver, Renal, Heart and Lungs function defined as:
- Creatininec≤1.5 ULN;
- ALT/AST ≤2.5 ULN;
- Total Bilirubin≤1.5×ULN;
- Pulse oxygenation≥92%;
- Left Ventricular Shortening Fraction (LVSF)≥50%;
- 6. Subjects could comprehend the clinical study and able to provide written consent at the time of consent or assent.
Who cannot join
- 1. Pregnant or lactating women, or men or women with pregnancy plans within 6 months.
- 2. Subjects with contagious disease，such as HIV, active HBV and HCV, and syphilis, etc.
- 3. Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation.
- 4. Subjects with severe autoimmune disease and long-term use of immunosuppressants.
- 5. Subjects with active or uncontrollable infections requiring systemic treatment within 14 days prior to enrollment.
- 6. Subjects with any unstable systemic disease including, but not limited to, active infection (except for local infection), unstable angina pectoris, cerebrovascular accident or transient cerebral ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification ≥ III).
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- 7. subjects combined with dysfunction of vital organs such as lung, brain and kidney.
- 8. subjects that Participated in other similar clinical trials within 6 months.
- 9. subjects currently receiving treatment for other gene therapy.
- 10. subjects combined with graft versus host disease (GVHD).
- 11. Other subjects judged by the researchers to be unsuitable for admission to the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000
Jiang Cao
Jiang Cao
About this study
This is a single arm, open-label, single center, exploratory clinical study to evaluate the safety and efficacy of CD19 UCAR-T Cells in Patients With CD19+ B-cell acute lymphoblastic leukemia (B-ALL).
Read the detailed description
This study did not set up a control group. The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD19 UCART cells per treatment course. The dose escalation test was designed to evaluate the three dose levels of CD19 UCART (1 × 10 ^ 6 cells/kg,3 × 10 ^ 6 cells/kg,5 × 10 ^ 6 cells/kg). Each CD19 UCART infusion will be carried out on day 0. Each subject was observed for at least 4 weeks after the last infusion. If there was no dose-limited toxicity (DLT), it is necessary to continue multiple treatment courses at this dose level. The detailed administration time and dose were decided by the researchers.
- Being tested
- CD19 UCARTcells
- 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 UCARTcellsBiological
This study did not set up a control group. The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD19 UCART cells per treatment course. The dose escalation test was designed to evaluate the three dose levels of CD19 UCART (1 × 10 ^ 6 cells/kg,3 × 10 ^ 6 cells/kg,5 × 10 ^ 6 cells/kg). Each CD19 UCART infusion will be carried out on day 0. Each subject was observed for at least 4 weeks after the last infusion. If there was no dose-limited toxicity (DLT), it is necessary to continue multiple treatment courses at this dose level. The detailed administration time and dose were decided by the researchers.
| Study group | Role | What they receive |
|---|---|---|
| CD19 UCAR-T | Experimental | Not described Receives: Biological: CD19 UCARTcells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Adverse events (AEs)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: 24 weeks
Graft-versus-Host Disease (GVHD)
Number of Participants with the GVHD by monitoring the epithelial cell damage in target organs including skin, liver, and gastrointestinal tract.
Measured: 42 days
Expression of CD19 UCART cells
Expression of CD19 UCART cells detected by flow cytometry in blood and bone marrow.
Measured: 2 years
Detection of CD19 UCART cells
Detection of CD19 UCART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).
Measured: 2 years
Secondary outcomes (7)
Overall Remission Rate (ORR)
Measured: 2 years
Complete Remission (CR)
Measured: 2 years
Disease Stabilization (SD)
Measured: 2 years
Disease Progression (PD)
Measured: 2 years
Overall survival (OS)
Measured: 2 years
Progression-free survival (PFS)
Measured: 2 years
Disease-free survival (DFS)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2019
- Study start8 Nov 2019 (estimated)
- Primary completion8 Nov 2019 (estimated)
- Study completion8 Nov 2019 (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 Leukemia (B-ALL)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Longyao Biotechnology Inc., Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yi Yao, ph.D, Study chair, Shanghai Longyao Bio-Tech Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04166838
- Sponsor's protocol ID
- V1.0
- Status last verified
- Nov 2019
- First submitted
- 10 Nov 2019
- Last updated
- 18 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of CD19 UCAR-T Cells in Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL)
- ClinicalTrials.gov ID
- NCT04166838
- Acronym / sponsor ID
- V1.0
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shanghai Longyao Biotechnology Inc., Ltd.University, hospital or other
- Study start
- 8 Nov 2019 (estimated)
- Primary completion
- 8 Nov 2019 (estimated)
- Study completion
- 8 Nov 2019 (estimated)
- First posted
- 18 Nov 2019 (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 arm, open-label, single center, exploratory clinical study to evaluate the safety and efficacy of CD19 UCAR-T Cells in Patients With CD19+ B-cell acute lymphoblastic leukemia (B-ALL).
Detailed description
This study did not set up a control group. The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD19 UCART cells per treatment course. The dose escalation test was designed to evaluate the three dose levels of CD19 UCART (1 × 10 ^ 6 cells/kg,3 × 10 ^ 6 cells/kg,5 × 10 ^ 6 cells/kg). Each CD19 UCART infusion will be carried out on day 0. Each subject was observed for at least 4 weeks after the last infusion. If there was no dose-limited toxicity (DLT), it is necessary to continue multiple treatment courses at this dose level. The detailed administration time and dose were decided by the researchers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD19 UCAR-T | Experimental | Biological: CD19 UCARTcells |
Who may qualify
- Ages
- 6 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- 1. Subjects between 6 and 70 years of age, inclusive.
- 2. Subjects diagnosed as relapsed or refractory B cell acute lymphocytic leukemia (B-ALL):
- 3. Life expectancy > 12 weeks.
- 4. ECOG score between 0 and 1.
- 5. Liver, Renal, Heart and Lungs function defined as:
Key exclusion criteria (11 listed)
- 1. Pregnant or lactating women, or men or women with pregnancy plans within 6 months.
- 2. Subjects with contagious disease，such as HIV, active HBV and HCV, and syphilis, etc.
- 3. Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation.
- 4. Subjects with severe autoimmune disease and long-term use of immunosuppressants.
- 5. Subjects with active or uncontrollable infections requiring systemic treatment within 14 days prior to enrollment.
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 UCARTcellsThis study did not set up a control group. The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD19 UCART cells per treatment course. The dose escalation test was designed to evaluate the three dose levels of CD19 UCART (1 × 10 ^ 6 cells/kg,3 × 10 ^ 6 cells/kg,5 × 10 ^ 6 cells/kg). Each CD19 UCART infusion will be carried out on day 0. Each subject was observed for at least 4 weeks after the last infusion. If there was no dose-limited toxicity (DLT), it is necessary to continue multiple treatment courses at this dose level. The detailed administration time and dose were decided by the researchers. | Biological | CD19 UCAR-T |
Primary outcome
The Adverse events (AEs)
Time frame: 24 weeks
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Graft-versus-Host Disease (GVHD)
Time frame: 42 days
Number of Participants with the GVHD by monitoring the epithelial cell damage in target organs including skin, liver, and gastrointestinal tract.
Expression of CD19 UCART cells
Time frame: 2 years
Expression of CD19 UCART cells detected by flow cytometry in blood and bone marrow.
Detection of CD19 UCART cells
Time frame: 2 years
Detection of CD19 UCART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).
7 secondary outcomes
Overall Remission Rate (ORR)
Time frame: 2 years
Complete Remission (CR)
Time frame: 2 years
Disease Stabilization (SD)
Time frame: 2 years
Disease Progression (PD)
Time frame: 2 years
Overall survival (OS)
Time frame: 2 years
Progression-free survival (PFS)
Time frame: 2 years
Disease-free survival (DFS)
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
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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.
Yi Yao, ph.D study chair
Shanghai Longyao Bio-Tech Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CD19 UCARTcells in people with B-cell Acute Lymphoblastic Leukemia (B-ALL) and Safety and Efficacy of CD19 UCAR-T Cells, run by Shanghai Longyao Biotechnology Inc., 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 13 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 18 Nov 2019. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Tengfeng Ni, Master (+86 021- 66289710, nitengfeng@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Adverse events (AEs) (time frame: 24 weeks). The study lists 4 primary outcomes in all. 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 18 Nov 2019; AzTrials last refreshed its copy on 7 Nov 2026.