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This is an open, single-arm, phase I clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of Non-hodgkin's lymphoma. A total of 100 patients are planned to be enrolled over a period of 3 years.
Chimeric antigen receptor (CAR)-modified T cells targeted against CD19 have demonstrated unprecedented successes in treating patients with hematopoietic and lymphoid malignancies. In this study, investigators will evaluate their safety and efficacy in patients with different types of hematopoietic and lymphoid malignancies. The primary goal is safety assessment including cytokine storm response and any other adverse effects. In addition, tumor targeting and disease status after treatment will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| volunteers | Experimental | The patient voluntarily signs the informed consent, and the patient meets the entry criteria to diagnose patients with Relapsed Refractory (R/R) non-Hodgkin lymphoma |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19 CAR-T | Drug | CD19 CAR-T for CD19 positive R/R non-Hodgkin lymphoma |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Severe/Adverse Events as a Measure of Safety | Number of Participants with Severe/Adverse Events as a Measure of Safety | 28 days |
| CAR-T Cell expansion level | Copies numbers of CAR in peripheral blood(PB) and/or bone marrow(BM) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate of complete remission and partial remission | Objective response rate of complete remission and partial remission | 24 months |
| Overall survival time | Overall survival time |
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Inclusion Criteria:
Fully understand and voluntarily sign the informed consent, and are willing and able to comply with the visit, treatment protocol, laboratory examination and other requirements of the study as set out in the trial procedure sheet;
Cd19-positive R/R NHL patients: recurrent or refractory patients were defined as diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle cell lymphoma (MCL), mucosa-associated lymphoid tissue lymphoma (MALTL), and Burkit lymphoma (BL) diagnosed by histopathology.
To standard treatment for primary drug resistance, or after treatment for at least two line standard specification treatment of PD, or the last treatment effect for SD and duration less than 6 months, or CD20 positive patients by the resistance against CD20 single treatment is invalid or has a relapse, or autologous hematopoietic stem cell transplantation in PD or 12 months after the confirmed by biopsy has a relapse, or to save patients after autologous hematopoietic stem cell transplantation for at the end of the line no ease or relapse after treatment;
There should be at least one measurable tumor focal point;
Karnofsky [2] score 50 or more;
Tumor cells were CD19 positive by immunohistochemistry or flow cytometry;
The expected survival time is greater than 3 months;
Pregnancy tests for women of childbearing age must be negative; Both men and women should agree to use effective contraceptives during treatment and for the following 1 year;
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jianqiang Li, Phd&MD | Contact | 86-311-82970975 | hr@senlangbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Jianmin luo, PhD&MD | The Second Hospital of Hebei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| No.2 Hospital of Hebei Medical University | Recruiting | Shijiazhuang | Hebei | 050000 | China |
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| ID | Term |
|---|---|
| C024352 | fludarabine |
| D007252 | Influenza Vaccines |
| D003520 | Cyclophosphamide |
| D053493 | Cholestanetriol 26-Monooxygenase |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| CD22 CAR-T | Drug | CD22 CAR-T for CD22 positive R/R non-Hodgkin lymphoma |
|
|
| CD19+CD22 CAR-T | Drug | CD19+CD22 CAR-T for CD19 positive and CD22 positive R/R non-Hodgkin lymphoma |
|
|
| Fludarabine | Drug | 25mg/㎡ for D-4、D-3 and D-2 |
|
|
| Cyclophosphamide | Drug | 500mg/㎡ for D-3 and D-2 |
|
|
| 24 months |
| D010752 |
| Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D000072501 | Cytochrome P450 Family 27 |
| D003577 | Cytochrome P-450 Enzyme System |
| D003580 | Cytochromes |
| D045762 | Enzymes and Coenzymes |
| D013250 | Steroid Hydroxylases |
| D006899 | Mixed Function Oxygenases |
| D010105 | Oxygenases |
| D010088 | Oxidoreductases |
| D004798 | Enzymes |
| D006420 | Hemeproteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |