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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 prognosis of patients with relapsed and/or refractory T-cell hematologic malignancies is poor due to lacking sufficient treatment.Anti-CD(cluster of differentiation antigen)19 CAR(chimeric antigen receptor)-T cell therapies are efficient for patients with B-cell hematologic malignancies. As for T-cell hematologic malignancies, CD7 is a promising target expressed on most malignant T cells. The outcome of CD-7 CAR-T cell therapy pre-clinical experiments is cheerful.however, how to select the functional T cells from the malignant T cells is a challenge. In addition to this, auto-CAR-T cell therapy is not affordable for the majority of patients. Using T cells aphesis from healthy donors edited to avoid rejection of the host as the material of anti-CD7 universal CAR-T cells could be accessible and affordable, which is adapted for patients with CD7+ relapsed and/or refractory T/NK-cell hematologic malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti-CD7 UCAR-T cells | Experimental | After preconditioning with chemotherapy ( Fludarabine, Cytoxan and/or Melphalan), the dosage of anti-CD7 UCAR-T cells between 1 and 5 ×10^7 cells/Kg will be evaluated |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD7 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-CD7 UCAR-T cells | ratio of bone marrow blast cells and/or the measurable lesion size and standralized uptake value | 4 weeks after infusion |
| Measure | Description | Time Frame |
|---|---|---|
| the long-term efficiency of anti-CD7 UCAR-T cells | ratio of bone marrow blast cells and/or the measurable lesion size and standralized uptake value | 3 and 6 months after infusion |
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Inclusion Criteria:
1. Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL, including Angioimmunoblastic T-cell lymphoma (AITL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL), Peripheral T-cell lymphoma (PTCL) NOS, Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia/lymphoma, T cell prolymphocytic leukemia with symptomatic disease, Extranodal NK/T cell lymphoma, Mycosis fungoides/ Sezary Syndrome Stage IIB or higher))
2. CD7-positive tumor (≥20% CD7 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. 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 | +8618984398751 | +8618984398751 | 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 | Recruiting | Chongqing | Chongqing Municipality | 400037 | China |
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| ID | Term |
|---|---|
| D015458 | Leukemia, T-Cell |
| D016399 | Lymphoma, T-Cell |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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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 | 600mg/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 |
|
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| 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 |