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| Name | Class |
|---|---|
| Hebei Taihe Chunyu Biotechnology Co., Ltd | INDUSTRY |
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CD7 molecules are thought to be associated with disease aggressiveness, drug resistance, and poor prognosis. Intensive chemotherapy, immunotherapy, hematopoietic stem cell transplantation (HSCT) and other treatment regimens have achieved remarkable results in the treatment of hematologic malignant diseases. Nevertheless, patients with hematologic malignancies may still tolerate acquired therapy during the above treatments, and molecular targeted immunotherapy provides a safe, efficient and specific treatment for such patients The scheme has attracted more and more researchers' attention. The use of CD7 molecules as a new target for molecularly targeted anti-tumor therapy may provide a new research direction for the treatment of CD7 relapsed/refractory hematologic malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD7 CAR-T | Experimental | For intravenous infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD7 CART | Biological | For intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the safety of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia | the incidence and severity of immune therapy related toxic reactions (irAEs) | up to one month after the CAR-T infusion |
| Evaluate the effcacy of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia | CR rate on M1 and M3 | one month and three month after the CAR-T infusion |
| Evaluate the effcacy of CD7 CAR-T cell therapy in relapsed/refractory malignant lymphoma/acute leukemia | ORR(CR and PR) on M1 and M3 | one month and three month after the CAR-T infusion |
| Measure | Description | Time Frame |
|---|---|---|
| long-term efficacy | DOR | up to one year after the CAR-T infusion |
| long-term efficacy | PFS | up to one year after the CAR-T infusion |
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Inclusion Criteria:
Subjects must meet all of the following criteria to be enrolled:
Subjects diagnosed with relapsed/refractory lymphoma/leukemia:
i) Relapse: After achieving complete remission with a standard treatment regimen (including hematopoietic stem cell transplantation), blasts appear in peripheral blood or bone marrow (proportion>5%), or extramedullary diseases occur; ii) Refractory: No complete remission after at least two courses of standard induction therapy.
Bone marrow flow cytometry detected tumor cells as CD7 and/or extramedullary lesions with a clear diagnosis of CD7 by pathological immunohistochemistry at the time of enrollment screening;
If tumor cells are detected in peripheral blood during enrollment screening, flow cytometry must be used to detect that the immunophenotype of tumor cells on the surface of tumor cells is both negative for CD4 and CD8. If the immunophenotype on the surface of peripheral blood tumor cells is not CD4 and CD8 negative, the proportion of peripheral blood tumor cells must be ≤1%;
Expected survival greater than 3 months from the date of signing the informed consent form;
Subjects with a performance status of 0~2 in the Eastern Cooperative Oncology Group (ECOG) score;
14 years old≤ age ≤ 75 years old, male or female;
HGB at least ≥70g/L, blood transfusion is available;
Liver and kidney function, heart and lung function meet the following requirements:
Subject or guardian understands and signs the informed consent form.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| long-term efficacy | OS | up to one year after the CAR-T infusion |
| Cell pharmacokinetics Dynamic indicators | CAR-T/T% by flow cytometry | Day7, Day10, Day14, Day28 after the CAR-T infusion |
| Cell pharmacokinetics Dynamic indicators | CARgene copy numbers by qPCR | Day7, Day10, Day14, Day28 after the CAR-T infusion |
| Cell pharmacokinetics Dynamic indicators | Area under the plasma concentration versus time curve(AUC) | up to one month after the CAR-T infusion |
| Cell pharmacokinetics Dynamic indicators | Peak Plasma Concentration (Cmax) | up to one mpnth after the CAR-T infusion |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |