Acute Lymphoblastic Leukemia Clinical Trial
Official title:
Treatment of Chemotherapy Resistant or Refractory Acute Lymphoblastic Leukemia by Chimeric Antigen Receptor (CAR)-Modified T Cells
Traditional standard treatments of B cell acute lymphoblastic leukemia is not perfect for fighting cancer. Many people do not respond to the standard treatments of ALL. One possible treatment is chimeric antigen receptor (CAR) modified T cell infusions. This study aims to evaluate the safety and efficacy of novel CARTs (targeting CD19) in the treatment of refractory or recurrent ALL.The investigators start Phase I study aimed to chemotherapy resistant or refractory acute lymphoblastic leukemia patients. The purpose of this study is to assess the safety and effectiveness of CAR-T cells in patients.
| Status | Recruiting |
| Enrollment | 5 |
| Est. completion date | December 2021 |
| Est. primary completion date | October 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | Inclusion Criteria: - Age: 18-65 years - Patients with Cluster of Differentiation 19 (CD19) positive B cell malignancies as confirmed by flow cytometry - Refractory or relapsed B cell-acute lymphoblastic leukemia - No available curative treatment options (such as hematopoietic stem cell transplantation) - Stage III-IV disease - Creatinine < 2.5 mg/dl - Aspartate transaminase-alanine transaminase ratio < 3x normal - Bilirubin < 2.0 mg/dl - Karnofsky performance status >= 60 - Expected survival time > 3 months - Adequate venous access for apheresis - Ability to understand and provide informed consent Exclusion Criteria: - Pregnant or lactating women - Patients requiring T cell immunosuppressive therapy - Active central nervous system leukemia - Any concurrent active malignancies - Patients with a history of a seizure disorder or cardiac disorder - Patients with human immunodeficiency virus, hepatitis B or C infection - Uncontrolled active infection |
| Country | Name | City | State |
|---|---|---|---|
| China | Department of Hematopoietic Stem Cell Transplantation | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Affiliated Hospital to Academy of Military Medical Sciences |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Adverse Events | To evaluate the safety of CAR-T cells in adult patients with B-acute lymphoblastic leukemia | 8 weeks | |
| Secondary | Clinical responses to third generation CAR-T cells | To assess the anti-leukemic effect of CAR-T cells in adult patients with B cell-acute lymphoblastic leukemia | 2 years |
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