- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03854994
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Peixian Zhang
- Phone Number: 86-0871-63211268
- Email: px29@163.com
Study Locations
-
-
Yunnan
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Kunming, Yunnan, China, 650000
- Recruiting
- Kunming Yan'an Hospital, Oncology Department
-
Contact:
- Lan Shi
- Phone Number: 86-18988158897
- Email: shi_lanlan@yahoo.com
-
Contact:
- Jiabao Song
- Phone Number: 86-15663656065
- Email: jiabaosong668@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients or their legal guardians voluntarily participate and sign the Informed Consent Document;
- 18 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.
5、 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;
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Anti-CD19 CAR-T Cells Injection
Dosage 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
|
Autologous genetically modified anti-CD19 CAR transduced T cells
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants with severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability.
Time Frame: 0 to 14 days post infusion
|
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)
Time Frame: 1 year post infusion
|
Copies numbers of CAR in peripheral blood (PB)
|
1 year post infusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall survival
Time Frame: 2 years post infusion
|
For all subjects, overall survival refers to the period from being included in the test group to death caused by any reason
|
2 years post infusion
|
Duration of Response after administration
Time Frame: 2 years post infusion
|
Duration of Response after administration
|
2 years post infusion
|
Progress Free Survival after administration
Time Frame: 2 years post infusion
|
Progress Free Survival after administration
|
2 years post infusion
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Peixian Zhang, Kunming Yan'an Hospital
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201707202
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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