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| Name | Class |
|---|---|
| The First Affiliated Hospital of Zhengzhou University | OTHER |
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Phase I was a single arm, open label, dose increasing study to explore the safety, tolerance and Cytodynamic characteristics of the drug, and to preliminarily observe the efficacy of the study drug in relapsed / refractory CD7 Positive hematolymph system malignant tumor patients, so as to explore the clinical applicable dose of phase II. Since the activity and toxicity of cellular drugs (long-term survival drugs) do not have obvious dose dependence, and the increase of their dose may be accompanied by the increase of toxicity, rather than necessary for therapeutic effect, it is not necessarily suitable to recommend the effective dose according to the maximum tolerable dose (MTD). Therefore, this study will be based on the safety data, as well as the preliminary efficacy, efficacy and drug The end point of pharmacokinetics (ORR, the content of CD7 Positive Cells, the expansion and duration of car-t cells) were comprehensively considered to determine the recommended dose for phase II clinical trial.Main research purposes Objective to evaluate the safety and tolerability of T cell injection targeting CD7 autologous chimeric antigen receptor in the treatment of relapsed / refractory CD7 Positive hematological and lymphoid malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| T cell injection targeting CD7 chimeric antigen receptor | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| T cell injection targeting CD7 chimeric antigen receptor | Biological | Drug name: T cell injection targeting CD7 autologous chimeric antigen receptor. Package specification: 10-50ml bag, 1-4 bags / person, which is determined according to the body weight of the subject and the effective content of cell preparation |
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting toxicity (DLT) | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety results | Number of adverse events | Up to 2 years |
| PK | The maximum concentration (Cmax) | Up to 2 years |
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Inclusion Criteria:
The age ranged from 7 to 70 years (including the cut-off value), regardless of gender
The expected survival time was more than 6 weeks
ECOG score 0-1
Malignant lymphoma (including but not limited to acute T-lymphoblastic leukemia / lymphoma; extramedullary NK / T-cell lymphoma, nasal type; peripheral T-cell lymphoma, nonspecific; vascular immunoblastic T-cell lymphoma; intestinal disease associated T-cell lymphomas; anaplastic large cell lymphoma (ALK -); T-cell lymphoblastic leukemia)
When screening, hematological malignancies with CD7 Positive confirmed by bone marrow examination or tumor pathology with positive rate of CD7 ≥ 30%, meeting one of the following conditions:
For peripheral blood involved acute T-lymphoblastic leukemia / lymphoma and NK / T-cell lymphoma, patients with TCR rearrangement were detected by ngs
The liver and kidney function, heart and lung function meet the following requirements:
Understand the experiment and have signed the informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mingzhi Zhang, Doctor | Contact | +8613838565629 | mingzhi_zhang@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450000 | China |
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CD7-CART
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| PK | the time to reach the maximum concentration (Tmax) | Up to 2 years |
| PK | The area under the curve (auc0-28d ) at 28d respectively after administration | Up to 2 years |
| PD | Absolute value of CD7 Positive Cells in peripheral blood at each time point | Up to 2 years |
| PD | The proportion of CD7 Positive Cells in peripheral blood at each time point | Up to 2 years |
| ORR | The total response rate was 3 months and 6 months | Up to 2 years |
| overall survival (OS) | Time from initiation of CD7 car-t cell therapy to death (for any reason) | Up to 2 years |
| Search Results Featured snippet from the web Duration of response (DOR) | The time from the first assessment of Cr or PR to the first assessment of recurrence or progression of the disease or death from any cause | Up to 2 years |
| Progression-free survival (PFS) | The time from the beginning of treatment with CD7 car-t cells to the first progression of disease or death from any cause | Up to 2 years |
| Immunogenicity | The positive rate of human anti car antibody at each time point | Up to 2 years |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D016411 | Lymphoma, T-Cell, Peripheral |
| D007119 | Immunoblastic Lymphadenopathy |
| D058527 | Enteropathy-Associated T-Cell Lymphoma |
| D017728 | Lymphoma, Large-Cell, Anaplastic |
| ID | Term |
|---|---|
| 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 |
| D016399 | Lymphoma, T-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D000072281 | Lymphadenopathy |
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