Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Tongji Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
This is a single center, single arm, open-label, dose escalation, phase 1 study to evaluate the safety, tolerability and preliminary efficacy of KSV01 Injection for patients with diffuse large B-cell lymphoma.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KSV01 Injection | Experimental | KSV01 Injection is one kind of third-generation non-replicative self-inactivating lentivirus vector which carries CD19 CAR. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KSV01 Injection | Drug | KSV01 Injection is one kind of third-generation non-replicative self-inactivating lentivirus vector which carries CD19 CAR. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose-limiting Toxicity | DLT evaluation period: The DLT evaluation period is defined as within 28 days (inclusive) after the subjects' first administration of KSV01 injection during the dose escalation stage. All adverse events should be graded and evaluated in accordance with CTCAE v5.0. Among them, cytokine release syndrome (CRS) and immune effector cell-related neurotoxicity syndrome (ICANS) should be determined and graded in accordance with the standards of the American Society for Transplantation and Cell Therapy (ASTCT). | 28 days after administration |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
History of another primary malignancy that has not been in continuous remission for at least 2 years, except for the following conditions which are exempt from the 2-year limit: non-melanoma skin cancer, Stage I solid tumors treated with curative intent and low risk of recurrence, cured localized prostate cancer, biopsy-confirmed carcinoma in situ of the cervix, or squamous intraepithelial lesion identified on Pap smear.
Uncontrolled infectious disease within 4 weeks prior to enrollment.
Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
HIV infection.
Positive for Treponema pallidum(syphilis).
Severe autoimmune disease or immunodeficiency, with the exception of well-controlled Type I diabetes and thyroid disorders.
History of severe allergy or hypersensitivity to macromolecular biologic agents (e.g., antibodies, cytokines).
Participation in any other clinical trial within 4 weeks prior to enrollment.
History of clinically significant central nervous system (CNS) diseases, including but not limited to epilepsy, paresis, aphasia, stroke, severe head injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome.
Presence of isolated CNS involvement by lymphoma, or any ongoing CNS condition that precludes accurate neurological evaluation.
History of severe cardiovascular conditions within the past 6 months.
Presence of psychiatric illness.
History of drug abuse or addiction.
Use of the following medications or therapies:
Women who are breastfeeding.
In the investigator's judgment, the subject is unlikely to complete all protocol-required study visits or procedures (including follow-up visits) or unlikely to comply with the requirements for participation in this study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology | Recruiting | Wuhan | Hubei | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D016393 | Lymphoma, B-Cell |