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| Name | Class |
|---|---|
| Hunan Provincial People's Hospital | OTHER |
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This is a single arm, open-label, early phase I study, to determine the safety and efficacy of Novel CAR-T cell therapy in Hematological Malignancy treatment.
The Novel CAR-T contains either a scFv plus a PD-L1 blocker, or two scFvs, in a cytokine complex based outer memberane structure, this kind of structure enables the CAR-T cells to simultaneously target one or two targets on the tumor cell surface and enhance CAR-T cell persistence in tumor microenvironment,as well as stimulating innate T/NK cell activation and expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel CAR-T | Experimental | Novel CAR-T cells will be administered intravenously |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel CAR-T | Biological | A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of Novel CAR-T cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety (Incidence of treatment-related adverse events as assessed by CTCAE v4.03) | Incidence of treatment-related adverse events as assessed by CTCAE v4.03 | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Complete response rate[CR] (Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma) | Complete response rate per the revised International Working Group (IWG) Response Criteria for Malignant Lymphoma | 3 months |
| Partial response rate [PR] (Partial response rate per the revised International Working Group (IWG) Response Criteria) |
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Inclusion Criteria:
All subjects must personally sign and date the consent form before initiating any study specific procedures or activities;
All subjects must be able to comply with all the scheduled procedures in the study;
Clear diagnosis of hematological malignancy, including B-cell Non-Hodgkin lymphoma, B-cell lymphoblastic leukemia, multiple myeloma.
Fufill one or more of the following criteria: Relapsed after most recent therapy; Progressive disease in standard chemotherapy; Disease progression or relapsed after ASCT;
At least one clear indicator for hematological malignancy monitoring;
Aged <70 years;
Expected survival ≥12 weeks;
Eastern cooperative oncology group (ECOG) performance status of≤3;
Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks;
All other treatment induced adverse events must have been resolved to
≤grade 1;
Laboratory tests must fulfill the following criteria: ANC ≥ 1000/uL, HGB>70g/L, Platelet count ≥ 50,000/uL, Creatinine clearance ≤1.5 ULN, Serum ALT/AST ≤2.5 ULN, Total bilirubin ≤1.5 ULN (except in subjects with Gilbert's syndrome);
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ming Zhou | Contact | +86 0731 83928147 | zhouming_0321@163.com | |
| Bin Gao | Contact | +86 022 59060560 | 803 | bin.gao@timmune.com |
| Name | Affiliation | Role |
|---|---|---|
| Ming Zhou | Hunan Provincial People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hunan Provincial People's Hospital | Recruiting | Changsha | Hunan | 410005 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| D002051 | Burkitt Lymphoma |
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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Novel CAR-T Cell Therapy
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Partial response rate per the revised International Working Group (IWG) Response Criteria |
| 3 months |
| Duration of Response (The time from response to relapse or progression) | The time from response to relapse or progression | 24 months |
| Progression Free Survival (The time from the first day of treatment to the date on which disease progresses) | The time from the first day of treatment to the date on which disease progresses | 24 months |
| Overall Survival (The number of patient alive, with or without signs of cancer) | The number of patient alive, with or without signs of cancer | 24 months |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D054219 | Neoplasms, Plasma Cell |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006474 | Hemorrhagic Disorders |