Back to resultsCD19-CAR-T Cells in Patients With R/R B-ALL
Primary Purpose
B-cell Acute Lymphoblastic Leukemia
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
CD19-CAR-T Cells
Sponsored by
About this trial
This is an interventional treatment trial for B-cell Acute Lymphoblastic Leukemia
Eligibility Criteria
Inclusion Criteria:
- Obtain Informed Consent Form (ICF) voluntarily signed by the patient;
- Age 3-70 years old;
- Primary resistant or relapsed B-cell line acute lymphoblastic leukemia;
- B cells are positive for CD19 expression;
- Peripheral blood tumor cell load <50%; 6. KPS score >50 points;
7. Normal liver and kidney function; 8. Normal heart function; 9. Good follow-up compliance; 10. Women of childbearing age (15-49 years old) must have a pregnancy test within 7 days before treatment and have a negative result; Men and women with fertility should agree to use effective contraception to ensure that during the study period and following 3 months after treatment the women will not get pregnant.
Exclusion Criteria:
- Patients with non-B cell acute leukemia;
- Organ failure: Heart: Grade III and IV Liver: Class C with Child-Turcotte liver function classification Kidney: Renal failure and uremia Lung: severe respiratory failure Brain: Disabilities
- Active infection;
- Human immunodeficiency virus (HIV) positive;
- Acute and chronic graft-versus-host disease (GVHD)> Level 1；
- Pregnant or lactating women;
- Patients do not agree to use effective contraception during the treatment period and following 3 months;
- Patients who participated in other clinical studies at the same time;
- The researcher believes that there are other factors that are not suitable for inclusion in or influence the subject's participation in or completion of the study;
- Long-term use greater doses of hormones than physiological doses.
Sites / Locations
- Hebei Yanda Ludaopei HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CD19-CAR-T Cells
Arm Description
Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.
Outcomes
Primary Outcome Measures
Objective Response Rate, ORR
The percentage of participants who achieved complete remission (CR) over all participants (CRR).
The percentage of participants who achieved partial remission (PR) over all participants (PRR).
Secondary Outcome Measures
The amount of CAR-T cells remaining in vivo
Measure and analyze monthly
The lifetime of CAR-T cells remaining in vivo
Measure and analyze monthly
Full Information
NCT ID
NCT03574168
First Posted
June 11, 2018
Last Updated
June 20, 2018
Sponsor
Bioceltech Therapeutics, Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03574168
Brief Title
CD19-CAR-T Cells in Patients With R/R B-ALL
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)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 20, 2018 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
December 31, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bioceltech Therapeutics, 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 center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
Detailed Description
Primary objective:
To investigate the safety and efficacy of autologous or HLA-haploidentical Allo-CD19-CAR-T cells in the treatment of patients with relapsed or refractory acute B-cell lymphoblastic leukemia.
Secondary objective:
To Assess the patient's quality of life after receiving the treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
B-cell Acute Lymphoblastic Leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CD19-CAR-T Cells
Arm Type
Experimental
Arm Description
Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.
Intervention Type
Biological
Intervention Name(s)
CD19-CAR-T Cells
Intervention Description
T cells purified from the PBMC of subjects or subjects' relatives which depends on their conditions, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.
Primary Outcome Measure Information:
Title
Objective Response Rate, ORR
Description
The percentage of participants who achieved complete remission (CR) over all participants (CRR).
The percentage of participants who achieved partial remission (PR) over all participants (PRR).
Time Frame
Up to Day90 after the CD19-CAR-T cell infusion
Secondary Outcome Measure Information:
Title
The amount of CAR-T cells remaining in vivo
Description
Measure and analyze monthly
Time Frame
2 years after cell infusion.
Title
The lifetime of CAR-T cells remaining in vivo
Description
Measure and analyze monthly
Time Frame
2 years after cell infusion.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Obtain Informed Consent Form (ICF) voluntarily signed by the patient;
Age 3-70 years old;
Primary resistant or relapsed B-cell line acute lymphoblastic leukemia;
B cells are positive for CD19 expression;
Peripheral blood tumor cell load <50%; 6. KPS score >50 points;
7. Normal liver and kidney function; 8. Normal heart function; 9. Good follow-up compliance; 10. Women of childbearing age (15-49 years old) must have a pregnancy test within 7 days before treatment and have a negative result; Men and women with fertility should agree to use effective contraception to ensure that during the study period and following 3 months after treatment the women will not get pregnant.
Exclusion Criteria:
Patients with non-B cell acute leukemia;
Organ failure: Heart: Grade III and IV Liver: Class C with Child-Turcotte liver function classification Kidney: Renal failure and uremia Lung: severe respiratory failure Brain: Disabilities
Active infection;
Human immunodeficiency virus (HIV) positive;
Acute and chronic graft-versus-host disease (GVHD)> Level 1；
Pregnant or lactating women;
Patients do not agree to use effective contraception during the treatment period and following 3 months;
Patients who participated in other clinical studies at the same time;
The researcher believes that there are other factors that are not suitable for inclusion in or influence the subject's participation in or completion of the study;
Long-term use greater doses of hormones than physiological doses.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zhongwei Xu, MD, Phd
Phone
+86 010-69739722
Email
willyxu001@bioceltech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peihua Lu, MD, PhD
Organizational Affiliation
Hebei Yanda Ludaopei Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hebei Yanda Ludaopei Hospital
City
Langfang
State/Province
Hebei
ZIP/Postal Code
065000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peihua Lu, MD, PhD
Phone
18611636172
Email
peihua_lu@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
CD19-CAR-T Cells in Patients With R/R B-ALL
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