Multiple Myeloma Clinical Trial
Official title:
Adoptive Immunotherapy for Hematological Malignancy With Novel CAR-T Cells.
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.
Status | Recruiting |
Enrollment | 9 |
Est. completion date | December 31, 2021 |
Est. primary completion date | August 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 70 Years |
Eligibility |
Inclusion Criteria: 1. All subjects must personally sign and date the consent form before initiating any study specific procedures or activities; 2. All subjects must be able to comply with all the scheduled procedures in the study; 3. Clear diagnosis of hematological malignancy, including B-cell Non-Hodgkin lymphoma, B-cell lymphoblastic leukemia, multiple myeloma. 4. Fufill one or more of the following criteria: Relapsed after most recent therapy; Progressive disease in standard chemotherapy; Disease progression or relapsed after ASCT; 5. At least one clear indicator for hematological malignancy monitoring; 6. Aged <70 years; 7. Expected survival =12 weeks; 8. Eastern cooperative oncology group (ECOG) performance status of=3; 9. Systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 4 weeks; 10. All other treatment induced adverse events must have been resolved to =grade 1; 11. 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: 1. Presence of fungal, bacterial, viral, or other infection that is hardly to control (defined by investigator); 2. Patients with symptomatic central nervous system metastasis, intracranial metastasis, and cancer cells found in cerebrospinal fluid are not recommended to participate in this study. Symptom free or post-treatment stable disease or disappearance of lesions should not be excluded. The specific selection is ultimately determined by the investigator; 3. Lactating women or women of childbearing age who plan to conceive during the investigational time period; 4. Active infection with hepatitis B (HBsAG positive) or hepatitis C virus (anti-HCV positive); 5. Known history of infection with HIV; 6. Subjects need systematic usage of corticosteroid; 7. Subjects need systematic usage of immunosuppressive drug; 8. Planed operation, history of other related disease, or any other related laboratory tests restrict patients for the study; 9. Other reasons the investigator consider the patient may not be suitable for the study. |
Country | Name | City | State |
---|---|---|---|
China | Hunan Provincial People's Hospital | Changsha | Hunan |
Lead Sponsor | Collaborator |
---|---|
Timmune Biotech Inc. | Hunan Provincial People's Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Partial response rate [PR] (Partial response rate per the revised International Working Group (IWG) Response Criteria) | Partial response rate per the revised International Working Group (IWG) Response Criteria | 3 months | |
Secondary | Duration of Response (The time from response to relapse or progression) | The time from response to relapse or progression | 24 months | |
Secondary | 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 | |
Secondary | 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 |
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