Back to resultsThe Clinical Study of CD19 UCAR-T Cells in Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL)
Primary Purpose
B-cell Acute Lymphoblastic Leukemia (B-ALL), Safety and Efficacy of CD19 UCAR-T Cells
Status
Unknown status
Phase
Early Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19 UCARTcells
Sponsored by
About this trial
This is an interventional treatment trial for B-cell Acute Lymphoblastic Leukemia (B-ALL)
Eligibility Criteria
Inclusion Criteria:
- 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.
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.
Exclusion Criteria:
- 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).
- 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.
Sites / Locations
- The Affiliated Hospital of Xuzhou Medical UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CD19 UCAR-T
Arm Description
Outcomes
Primary Outcome Measures
The Adverse events (AEs)
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
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.
Expression of CD19 UCART cells
Expression of CD19 UCART cells detected by flow cytometry in blood and bone marrow.
Detection of CD19 UCART cells
Detection of CD19 UCART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).
Secondary Outcome Measures
Overall Remission Rate (ORR)
Complete Remission (CR)
Disease Stabilization (SD)
Disease Progression (PD)
Overall survival (OS)
Progression-free survival (PFS)
Disease-free survival (DFS)
Full Information
NCT ID
NCT04166838
First Posted
November 10, 2019
Last Updated
November 14, 2019
Sponsor
Shanghai Longyao Biotechnology Inc., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04166838
Brief Title
The Clinical Study of CD19 UCAR-T Cells in Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL)
Official Title
The Clinical Study of CD19 UCAR-T Cells in Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 8, 2019 (Anticipated)
Primary Completion Date
November 8, 2019 (Anticipated)
Study Completion Date
November 8, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Longyao Biotechnology Inc., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Acute Lymphoblastic Leukemia (B-ALL), Safety and Efficacy of CD19 UCAR-T Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CD19 UCAR-T
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
CD19 UCARTcells
Intervention 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.
Primary Outcome Measure Information:
Title
The Adverse events (AEs)
Description
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time Frame
24 weeks
Title
Graft-versus-Host Disease (GVHD)
Description
Number of Participants with the GVHD by monitoring the epithelial cell damage in target organs including skin, liver, and gastrointestinal tract.
Time Frame
42 days
Title
Expression of CD19 UCART cells
Description
Expression of CD19 UCART cells detected by flow cytometry in blood and bone marrow.
Time Frame
2 years
Title
Detection of CD19 UCART cells
Description
Detection of CD19 UCART cells in blood, bone marrow by Quantitative Polymerase Chain Reaction (q-PCR).
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Overall Remission Rate (ORR)
Time Frame
2 years
Title
Complete Remission (CR)
Time Frame
2 years
Title
Disease Stabilization (SD)
Time Frame
2 years
Title
Disease Progression (PD)
Time Frame
2 years
Title
Overall survival (OS)
Time Frame
2 years
Title
Progression-free survival (PFS)
Time Frame
2 years
Title
Disease-free survival (DFS)
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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.
Exclusion Criteria:
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).
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tengfeng Ni, Master
Phone
+86 021- 66289710
Email
nitengfeng@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi Yao, ph.D
Organizational Affiliation
Shanghai Longyao Bio-Tech Co., Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
ZIP/Postal Code
221000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiang Cao
First Name & Middle Initial & Last Name & Degree
Jiang Cao
12. IPD Sharing Statement
Learn more about this trial
The Clinical Study of CD19 UCAR-T Cells in Patients With B-cell Acute Lymphoblastic Leukemia (B-ALL)
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