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This is an open label, single-site, dose-escalation study in up to 18 participants with treatment of relapsed/refractory B-cell lymphoma. This study aims to evaluate the safety and efficacy of the treatment with an Anti- CD19 gene injection
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti CD19 Gene Therapy for B-cell Lymphoma | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-CD19 gene injection | Drug | Intravenous infusion of Anti-CD19 gene injection (three dosage groups) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Total number, incidence and severity of adverse events (AEs) in patients of LCAR1901 infusion. The AEs will be assessed according to the 2019 Consensus on Cytokine Release Syndrome and Immune-cell-associated Neurotoxicity published by the American Society of Transplantation and Cell Therapy (ASTCT), the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0 and EBMT 2019 consensus. | up to 1 years |
| The persistence, accumulation, and migration of anti-CD19 gene injection | Assessing the trafficking of anti-CD19 gene injection in the peripheral blood at the time of each infusion as well as at each time of follow-up by Quantitative Real-time Polymerase Chain Reaction or flow cytometry. Peripheral blood will be collected prior to the initial infusion and will be set as baseline. | up to 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response (CR) rate | Evaluation of disease efficacy according to the 2014 Lugano criteria. CR rate is defined as the proportion of patients who have achieved CR assessed by investigators. | up to 1 year |
| Objective response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
(1) Patients who have experienced central nervous system diseases or pathological changes within 6 months before screening, including but not limited to: stroke, cerebrovascular accident, aneurysm, epilepsy, convulsions, aphasia, severe traumatic brain injury, dementia, Parkinson's disease, cerebellar diseases, organic brain syndrome, or mental disorders.
(2) Patients with malignant tumors other than B-cell lymphoma. (3) Patients who received vaccines or B-cell targeted therapy within 4 weeks before screening.
(4) Patients with systemic autoimmune diseases or immunodeficiency. (5) Patients with grade 2-4 acute graft-versus-host disease (GVHD) or moderate to severe chronic GVHD within 4 weeks before screening.
(6) Patients with relatively severe heart disease, such as angina, myocardial infarction, heart failure, or arrhythmia.
(7) Patients with a history of severe allergies to the drugs or excipients used in the clinical study or investigational drugs.
(8) Patients with active hepatitis B, HCV antibody positivity, HIV antibody positivity, or positive for syphilis.
(9) Patients with active infections requiring intravenous antibiotics or hospitalization.
(10) Pregnant or breastfeeding women.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| wang xing bing, M.D | Contact | +86-0551-62284476 | wangxingbing@ustc.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anhui Provincial Hospital | Recruiting | Hefei | Anhui | 230001 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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ORR is defined as the proportion of patients who have achieved CR and partial response (PR) assessed by investigators.
| up to 1 year |
| Duration of Response (DOR) | DOR is defined as the date of their first CR or PR (which is subsequently confirmed) to PD assessed by investigators, or death regardless of cause. | up to 1 year |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |