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| Name | Class |
|---|---|
| Hebei Taihe Chunyu Biotechnology Co., Ltd | INDUSTRY |
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To observe the long-term efficacy and safety of dual-target chimeric antigen receptor T cells in the treatment of refractory relapsed B cell hematologic tumors (at least 2 years).
This study is open single-arm prospective clinical study To relapse/refractory blood B cell tumor patients as the subjects, according to the expression of tumor cells, gives the corresponding double targets CART cell injection treatment, follow-up observation of the adverse reactions and the treatment effect of the drug to the data (at least 2 years), assessment of double targets CAR - T Long-term efficacy and safety of cell injection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 19+22 CART and 19+20 CART | Experimental | Eligible patients will be treated with 19+22 CAR-T and 19+20 CAR-T. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous CD19/CD22/CD20 Chimeric Antigen Receptor T-cells | Biological | Single or sequential injection of CD19, CD20 and CD22 CAR T cells. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy: Remission Rate | Remission Rate includes complete remission(CR)、CR with incomplete blood count recovery(CRi)、No remission(NR) | Up to 3 months |
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Inclusion Criteria:
4.Estimated survival time>3 months; 5.ECOG Scores: 0~2; 6.There should be at least one measurable tumor foci according to RECIST Version 1.1; 7.The functions of vital organs must meet the following conditions: EF>50%, and no obvious abnormality of electrocardiogram; SpO2≥92%; Cr≤1.5ULN; ALTand AST≤5ULN, TBil≤3ULN; 8.Subjects planning to become pregnant must agree to use contraception prior to enrolling in the study and after six months of study duration; inform the investigator immediately if the subject becomes pregnant or suspects pregnancy; 9.The subject or guardian understands and signs the informed consent.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jia Wei, PhD&MD | Contact | 008602783665555 | jiawei@tjh.tjmu.edu.cn | |
| Na Kuang, PhD&MD | Contact | 008618630160116 | kuangna@senlangbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Jia Wei, PhD&MD | Tongji Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital | Recruiting | Wuhan | Hubei | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38062808 | Derived | He S, Peng J, Yang X, Meng F, Huang L, Huang L, Tian W, Gao Z, Zhao J, Wang Z, Wei J. Peripheral Blood Smears Distinguish Infective Fever after CAR-T Therapy. Front Biosci (Landmark Ed). 2023 Nov 24;28(11):299. doi: 10.31083/j.fbl2811299. |
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