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| Name | Class |
|---|---|
| Peking University Cancer Hospital & Institute | OTHER |
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n this study, approximately 30 patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) were recruited for a single reinfusion of IM19-CD28 and IM19-41BB CAR-T cells. Assess the safety, tolerability of treatment, and initially observe the efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IM19 CAR-T cells | Experimental | 3*10^5/kg,1*10^6/kg,3*10^6/kg IM19 CAR-T cell.Two days before cell infusion, all patients will be treated with fludarabine and Cyclophosphamide for 3 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IM19 | Biological | CAR-T cells |
| |
| Fludarabine |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of study related adverse events | >= Grade 3 signs/symptoms,laboratory toxicities,and clinical events that are possibly,likely,or definitely related to study treatment Adverse events assessed according to NCI-CTCAE v4.0 criteria 2. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate | (1) a morphologic complete response (CR) or (2) a complete response with incomplete recovery of counts (CRi) (based on NCCN guidelines (National Comprehensive Cancer Network (NCCN), 2014) | 2 years |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin-an Lu, Dr | Contact | 86-189-1157-6946 | luxinan@immunochina.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Recruiting | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34515338 | Derived | Ernst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2. | |
| 33632155 |
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| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D003520 | Cyclophosphamide |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
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| Drug |
Two days before cell infusion, all patients will be treated with fludarabine for 3 days |
|
| Cyclophosphamide | Drug | Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days |
|
| Ying Z, He T, Wang X, Zheng W, Lin N, Tu M, Xie Y, Ping L, Zhang C, Liu W, Deng L, Wu M, Feng F, Leng X, Du T, Qi F, Hu X, Ding Y, Lu XA, Song Y, Zhu J. Distribution of chimeric antigen receptor-modified T cells against CD19 in B-cell malignancies. BMC Cancer. 2021 Feb 25;21(1):198. doi: 10.1186/s12885-021-07934-1. |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |