Safety and Efficacy of CD19-Targeted CAR-T Therapy for Relapsed/Refractory CD19+ B Cell Leukemia and Lymphoma
NCT ID: NCT04271800
Last Updated: 2023-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2019-12-01
2024-07-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CD19 CAR-T cells treat
Patients will be be treated with CD19 CAR-T cells
CD19 CAR-T cells
A single infusion of CD19-CAR-T cells will be administered intravenously.
Interventions
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CD19 CAR-T cells
A single infusion of CD19-CAR-T cells will be administered intravenously.
Eligibility Criteria
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Inclusion Criteria
2. Diagnose as relapsed /refractory B Cell Leukemia and Lymphoma, and meet one of the following conditions:
1. Failed to standard chemotherapy regimens;
2. Relapse after complete remission, high-risk and / or refractory patients ;
3. Relapse after hematopoietic stem cell transplantation;
3. For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)；
4. Evidence for cell membrane CD19 expression;
5. All genders, ages: 3 to 75 years；
6. The expect time of survive is above 12 weeks;
7. KPS\>60；
8. No serious mental disorders ;
9. Left ventricular ejection fraction ≥50%
10. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
11. Sufficient renal function defined by creatinine clearance≤2 x ULN;
12. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
13. With single or venous blood collection standards, and no other cell collection contraindications;
14. Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Exclusion Criteria
2. Participated in other clinical research within 1 month before screening；
3. Have received the following anti-tumor treatment before screening: Have received chemotherapy, targeted therapy or other experimental drug treatment within 4 weeks, except those who have confirmed disease progression after treatment;
4. Live attenuated vaccine within 4 weeks before screening;
5. Convulsion or stoke within past 6 months;
6. Previous history of other malignancy;
7. Presence of uncontrolled active infection;
8. Subjects with positive HBsAg or HBcAb positive and peripheral blood HBV DNA titer is higher than the lower limit of detection of the research institution; HCV antibody positive and peripheral blood HCV RNA titer is higher than the lower limit of detection of the research institution; HIV antibody positive; syphilis primary screening antibody positive;
9. Pregnant or breasting-feeding women;
10. Any situation that investigators regard not suitable for attending in this study or may affect the data analysis.
3 Years
75 Years
ALL
No
Sponsors
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Chongqing Precision Biotech Co., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Cheng Qian, PhD
Role: PRINCIPAL_INVESTIGATOR
Chongqing University Cancer Hospital
Ying Xiang, MD
Role: PRINCIPAL_INVESTIGATOR
Chongqing University Cancer Hospital
Locations
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Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PBC014
Identifier Type: -
Identifier Source: org_study_id
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