CD19 CAR-T Cell Therapy for Relapsed/Refractory B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia
A Phase I Clinical Trial of Anti-CD19 Chimeric Antigen Receptor With Synthetic Biology Optimizing Nano-vector T Cells Injection for Subjects With Relapsed/Refractory/High-risk B-cell Lymphoma and B-cell Acute Lymphoblastic Leukemia
1 other identifier
interventional
10
1 country
1
Brief Summary
The primary objective of this study is to evaluate the safety and clinical activity of anti-CD19 Chimeric Antigen Receptor T cells (KD-019 CAR-T)infusion in the treatment of relapsed/refractory B-cell Lymphoma and 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 below P25 for phase_1
Started Aug 2018
Longer than P75 for phase_1
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
August 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 20, 2019
CompletedFirst Posted
Study publicly available on registry
February 26, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2022
CompletedFebruary 26, 2019
February 1, 2019
3 years
February 20, 2019
February 25, 2019
Conditions
Outcome Measures
Primary Outcomes (2)
Number of Participants with severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability.
The severe CRS post KD-019 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined.
0 to 14 days post infusion
Copies numbers of CAR in peripheral blood (PB)
Copies numbers of CAR in peripheral blood (PB)
1 year post infusion
Secondary Outcomes (3)
Overall survival
2 years post infusion
Duration of Response after administration
2 years post infusion
Progress Free Survival after administration
2 years post infusion
Study Arms (1)
Anti-CD19 CAR-T Cells Injection
EXPERIMENTALDosage form：injection Dosage:1-5x10\^6/kg, 70ml/time, The CAR-T cells will be administered by i.v. injection over 20-30 minutes Frequency: total one time
Interventions
Autologous genetically modified anti-CD19 CAR transduced T cells
Eligibility Criteria
You may qualify if:
- Patients or their legal guardians voluntarily participate and sign the Informed Consent Document;
- Years and older, Male and female;
- 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:
- B-cell acute lymphoblastic leukemia;
- Indolent B-cell lymphomas;
- Aggressive B-cell lymphoma; 4、 Subjects:
- (1) Residual lesions remain after treatment; (2) Not suitable for Hematopoietic stem cell transplantation (auto/allo-HSCT); (3) Relapse after Complement receptor 1 (CR1) and unsuitable for HSCT; (4) Patients with high risk factors; (5) Relapse or no remission after hematopoietic stem cell transplantation or cell immunotherapy.
- 、 Have measurable or evaluable tumor foci; 6、 Liver, kidney and cardiopulmonary functions meet the following requirements:
- Serum glutamic pyruvic transaminase (ALT) and serum glutamic oxaloacetic transaminase (AST) \<3 ×upper limit of normal (ULN);
- Total bilirubin ≤34.2μmol/L;
- Serum creatinine\<220μmol/L;
- Baseline oxygen saturation≥95%;
- Left ventricular ejection fraction（LVEF）≥40%. 7、 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); 8、Peripheral superficial venous blood flow is smooth, which can meet the needs of intravenous drip; 9、Clinical performance status of eastern cancer cooperation group (ECOG) score ≤2，Expected survival≥3 months;
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yan'an Affiliated Hospital of Kunming Medical Universitylead
- KAEDIcollaborator
Study Sites (1)
Kunming Yan'an Hospital, Oncology Department
Kunming, Yunnan, 650000, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peixian Zhang
Kunming Yan'an Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 20, 2019
First Posted
February 26, 2019
Study Start
August 1, 2018
Primary Completion
August 1, 2021
Study Completion
August 1, 2022
Last Updated
February 26, 2019
Record last verified: 2019-02