Status:
UNKNOWN
Anti-CD19 CAR in PiggyBac Transposon-Engineered T Cells for Relapsed/Refractory B-cell Lymphoma or B-cell Acute Lymphoblastic Leukemia
Lead Sponsor:
Yan'an Affiliated Hospital of Kunming Medical University
Conditions:
B Cell Lymphoma
B-cell Acute Lymphoblastic Leukemia
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Our previous study demonstrated that anti-CD19 chimeric antigen receptor in piggyBac transposon-engineered T cells have strong tumor-killing activity in vitro and therapeutic effects in cell line-deri...
Detailed Description
Using piggyBac transposon/transposase system to deliver genes into primary human T cells - example expression of CD19 CAR.CARs specific to the human CD19 antigen were used. All CARs contained the scFv...
Eligibility Criteria
Inclusion
- Patients or their legal guardians voluntarily participate and sign the Informed Consent Document;
- Male or female patients aged 18 to 70 years (inclusive);
- Pathologically and histologically confirmed CD19 + B cell tumors; Patients currently have no effective treatment options, such as chemotherapy or relapse after hematopoietic stem cell transplantation; Or patients voluntarily choose transfusion of anti-CD19 CAR-T cells as the first treatment program;
- B-cell tumors / lymphomas and B-cell acute lymphoblastic leukemia include the following four types:1) B-cell acute lymphoblastic leukemia;2) Indolent B-cell lymphomas;3) Aggressive B-cell lymphoma; 4) Multiple myeloma;
- Subjects:
- (1) Residual lesions remain after treatment and Not suitable for Hematopoietic stem cell transplantation (auto/allo-HSCT); (2) Relapse after Complement receptor 1 (CR1) and unsuitable for HSCT; (3) Patients with high risk factors; (4) Relapse or no remission after hematopoietic stem cell transplantation or cell immunotherapy.
- 6\. Have measurable or evaluable tumor foci;
- 7\. Liver, kidney and cardiopulmonary functions meet the following requirements:
- 1\) Serum glutamic pyruvic transaminase (ALT) and serum glutamic oxaloacetic transaminase (AST) \<3 ×upper limit of normal (ULN);2) Total bilirubin ≤34.2μmol/L;3) Serum creatinine\<220μmol/L;4) Baseline oxygen saturation≥95%;5) Left ventricular ejection fraction（LVEF）≥40%.
- 8\. Subjects who did not receive Chemotherapy, Radiotherapy, Immunotherapy (immunosuppressive drugs) or other treatment within 4 weeks prior to enrollment; Relevant toxicity≤1 grade before enrollment (except for low toxicity such as hair loss);
- 9\. Peripheral superficial venous blood flow is smooth, which can meet the needs of intravenous drip;
- 10\. Clinical performance status of eastern cancer cooperation group (ECOG) score ≤2,Expected survival≥3 months;
Exclusion
- Pregnant (urine/blood pregnancy test positive) or lactating women;
- Planned pregnancy during treatment or within 1 year after treatment, or a male subject whose partner plans pregnancy within 1 year of their cell transfusion;
- Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 year after enrollment;
- Active or uncontrollable infection within four weeks prior to enrollment;
- Patients with active hepatitis B/C;
- HIV-infected patients;
- Severe autoimmune or immunodeficiency disorders;
- Patients are allergic to macromolecule drugs such as antigens or cytokines;
- Subjects participated in other clinical trials within 6 weeks before enrollment;
- Systematic use of hormones within 4 weeks prior to enrollment (except for inhaled hormones);
- Mental illness;
- Drug abuse/addiction;
- The investigators consider other conditions unsuitable for enrollment.
Key Trial Info
Start Date :
March 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 15 2023
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04289220
Start Date
March 15 2020
End Date
September 15 2023
Last Update
May 13 2021
Active Locations (1)
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1
Kunming Yan'an Hospital
Kunming, Yunnan, China, 650000