The Clinical Study of CD19 UCAR-T Cells in Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL)
1 other identifier
interventional
20
1 country
1
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for early_phase_1
Started Nov 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 8, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 8, 2019
CompletedFirst Submitted
Initial submission to the registry
November 10, 2019
CompletedFirst Posted
Study publicly available on registry
November 18, 2019
CompletedNovember 18, 2019
November 1, 2019
Same day
November 10, 2019
November 14, 2019
Conditions
Outcome Measures
Primary Outcomes (4)
The Adverse events (AEs)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
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.
42 days
Expression of CD19 UCART cells
Expression of CD19 UCART cells detected by flow cytometry in blood and bone marrow.
2 years
Detection of CD19 UCART cells
Detection of CD19 UCART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).
2 years
Secondary Outcomes (7)
Overall Remission Rate (ORR)
2 years
Complete Remission (CR)
2 years
Disease Stabilization (SD)
2 years
Disease Progression (PD)
2 years
Overall survival (OS)
2 years
- +2 more secondary outcomes
Study Arms (1)
CD19 UCAR-T
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- \. Subjects between 6 and 70 years of age, inclusive.
- \. 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.
- \. Life expectancy \> 12 weeks.
- \. ECOG score between 0 and 1.
- \. 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%;
- \. Subjects could comprehend the clinical study and able to provide written consent at the time of consent or assent.
You may not qualify if:
- \. Pregnant or lactating women, or men or women with pregnancy plans within 6 months.
- \. Subjects with contagious disease，such as HIV, active HBV and HCV, and syphilis, etc.
- \. Subjects with mental or psychological illness who cannot be combined with treatment and efficacy evaluation.
- \. Subjects with severe autoimmune disease and long-term use of immunosuppressants.
- \. Subjects with active or uncontrollable infections requiring systemic treatment within 14 days prior to enrollment.
- \. 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).
- \. subjects combined with dysfunction of vital organs such as lung, brain and kidney.
- \. subjects that Participated in other similar clinical trials within 6 months.
- \. subjects currently receiving treatment for other gene therapy.
- \. subjects combined with graft versus host disease (GVHD).
- \. Other subjects judged by the researchers to be unsuitable for admission to the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Yi Yao, ph.D
Shanghai Longyao Bio-Tech Co., Ltd.
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 10, 2019
First Posted
November 18, 2019
Study Start
November 8, 2019
Primary Completion
November 8, 2019
Study Completion
November 8, 2019
Last Updated
November 18, 2019
Record last verified: 2019-11