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The is a multicenter, single arm, open label clinical study on the novel CAR-T combined expression of IL-15 in the treatment of malignant hematological tumors.Plan to recruit 45 subjects with malignant hematological tumors.
The main objective is to evaluate the safety and efficacy of a novel CAR-T therapy that co expresses IL-15 in malignant hematological tumors.
The secondary objective is to investigate the in vivo survival time of the novel CAR-T co expressing IL-15 and the activation and proliferation of a novel CAR-T co expressing IL-15 in vivo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group1 | Experimental | In patients with acute B-lymphoblastic leukemia, the dose was 0.5-1.5×10^6 CAR-positive T cells /kg body weight. The usual dose of B-cell non-Hodgkin lymphoma was 0.5-2.0 ×10^6/kg CAR-positive T cells. The initial dose of r/r multiple myeloma is 1x10^6/kg, and the dose of 3x10^6/kg and 5x10^6/kg are generally proposed to increase successively. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| chimeric antigen receptor gene modified T cells | Drug | The rate of intravenous infusion of CAR T cells was 10 mL to 20 mL/min, and the infusion was performed using a blood transfusion apparatus with a filter screen. Use saline rinsing tube prior to infusion; Rinse the infusion bag with 10 mL~30 mL normal saline. |
| Measure | Description | Time Frame |
|---|---|---|
| monitor the survival time of CAR-T in vivo | The survival of CAR-T in vivo will be monitored periodically by flow cytometry after CAR T reinfusion. | 6 months |
| Record antitumor effects after reinfusion of CAR-T | Determine partial response (PR) or complete response (CR) for subjects with active disease. In view of the small number of subjects, remission should be recorded in detail; For subjects treated with minimal residual lesion (MRD), MRD clearance results were recorded. | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | DFS was calculated from the first CAR-T cell infusion to death, progression of the disease, relapse or gene recurrence, whichever came first, or last visit. | 3 years |
| Overall Survival |
| Measure | Description | Time Frame |
|---|---|---|
| The copy number of CAR-T cells | The copy number of CAR-T cells amplified in peripheral blood after administration | 12 months |
Inclusion Criteria:
I (or the authorized representative/legal guardian) agree and have signed an informed consent form, and am willing and capable of following the planned visits, research treatments, laboratory tests, and other research procedures;
Histopathological or flow cytometric diagnosis of CD19 and/or CD22, BCMA-positive hematological malignancies;
-≥15 years old, ≤80 years old;
If you meet one of the following three conditions, you can be included in the group:-Patients with recurrent or refractory hematologic malignancies treated with one standard chemotherapy regimen and one salvage regimen;-Minimal residual lesions persist after treatment with one standard chemotherapy regimen and one salvage regimen;-Patients with recurrence after hematopoietic stem cell transplantation;
Estimated survival ≥12 weeks;
Good heart, liver and kidney function:
Serum creatinine ≤ 1.5 mg/dL (1mg/dl=88.4umol/L); Serum ALT/AST ≤ 2.5 ULN; Total bilirubin ≤ 1.5 mg/dl (1mg/dl=17.1umol/L):
Cardiac ejection fraction ≥50%, cardiac ultrasound showed centropericardial effusion:
Eastern Oncology Collaborative Group Activity Status Score (ECOG)0-3;
Able to understand and voluntarily sign informed consent; If the subject is a child, the guardian will sign the informed consent.
If the answer to any of the above is "no", the subject will not be allowed to participate in this study.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| JIA WEI | Contact | CHN13986102084 | ngc2237fh@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanxi Bethune Hospital | Recruiting | Taiyuan | Shanxi | 030000 | China |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D008228 | Lymphoma, Non-Hodgkin |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
OS was calculated from the first CAR-T cell infusion to death or last follow-up
| 3 years |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D008223 | Lymphoma |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006474 | Hemorrhagic Disorders |