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| Name | Class |
|---|---|
| Gracell Biotechnologies (Shanghai) Co., Ltd. | INDUSTRY |
| 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China | OTHER |
| The Second Affiliated Hospital of Chongqing Medical University |
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The stunning response rate of anti-CD19(cluster of differentiation antigen 19) auto-CAR(chimeric antigen receptor)-T cell therapy brings hope to patients with relapsed or refractory B-cell hematologic malignancies. However, based on open clinical trials, using patients' T cells might encounter the failure of apheresis available T cells, even if successful, the time needed for the manufacture could also cause the irreversible disease progress. Furthermore, the cost of auto-CAR-T cells is not affordable for most patients. So to provide an accessible and affordable anti-CD19 CAR-T cell therapy for patients with B-cell hematologic malignancies, we launch such a trial that using the edited T cells from healthy donors to manufacture universal CAR-T cells and adapt it in patients with CD19+ B-cell leukemia or lymphoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-CD19 UCAR-T cells | Experimental | After preconditioning with chemotherapy ( Fludarabine, Cytoxan and/or Melphalan), the dosage of anti-CD19 UCAR-T cells between 1 and 5 ×10^7 cells/Kg will be evaluated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-CD19 UCAR-T cells | Biological | Dose range:1 to 5 ×10^7 cells/Kg, Dose level one: 1×10^7 cells/Kg, Dose level two: 3×10^7 cells/Kg, Dose level three:5 ×10^7 cells/Kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| the anti-tumor efficiency of anti-CD19 UCAR-T cells | ratio of bone marrow blast cells and/or the measurable lesion size and strandralized uptake value | 4 weeks after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| the long-term efficiency of anti-CD19 UCAR-T cells | ratio of bone marrow blast cells and/or the measurable lesion size and strandralized uptake value | 3 and 6 months after infusion |
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Inclusion Criteria:
1. Diagnosis of recurrent B-cell acute lymphoblastic leukemia (B-ALL), B-cell acute lymphoblastic lymphoma (B-LLy), or B-non-Hodgkin lymphoma (B-NHL)
2. CD19-positive tumor (≥20% CD19 positive blasts by flow cytometry or immunohistochemistry (tissue))
3. Hgb ≥ 7.0 (can be transfused)
4. Life expectancy greater than 12 weeks
5. Informed consent explained to, understood by and signed by the patient/guardian. The patient/guardian is given a copy of informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xi Zhang, MD | Contact | +8613808310064 | +8613808310064 | zhangxxi@sina.com |
| Ruihao Huang | Contact | +86 18984398751 | 1169731117@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Xi Zhang, MD | Xinqiao Hospital of Chongqing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Xinqiao Hospital | Chongqing | Chongqing Municipality | 400037 | China |
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| ID | Term |
|---|---|
| D002051 | Burkitt Lymphoma |
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| D008558 | Melphalan |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| The Affiliated Hospital Of Guizhou Medical University | OTHER |
| Central South University | OTHER |
| First Affiliated Hospital of Kunming Medical University | OTHER |
| The General Hospital of Western Theater Command | OTHER |
| Second Affiliated Hospital of Xi'an Jiaotong University | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| Fujian Medical University Union Hospital | OTHER |
| The First Affiliated Hospital of Anhui Medical University | OTHER |
| Tang-Du Hospital | OTHER |
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| Fludarabine | Drug | 30mg/m^2 per day for 6 days |
|
| Cytoxan | Drug | 300mg/m^2 per day for 2 to 6 days determined by tumor burden at baseline |
|
| Melphalan | Drug | 50 to 70 mg/m^2 in total for 1 or 2 days, whether to use determined by tumor burden at baseline |
|
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010649 | Phenylalanine |
| D024322 | Amino Acids, Aromatic |
| D000598 | Amino Acids, Cyclic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |