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| Name | Class |
|---|---|
| Hebei Taihe Chunyu Biotechnology Co., Ltd | INDUSTRY |
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This study is an open, single arm, prospective, phase I clinical study, using "3+3" dose escalation to explore the safety, maximum tolerated dose, in vivo pharmacokinetic characteristics and preliminary efficacy of CAR19-BCMA dual-target CAR-T cell injection in the treatment of relapsed / refractory multiple myeloma subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR19-BCMA CAR-T | Experimental | This part follows the "3+3" dose escalation mode, with three dose groups (1E+06, 2E+06 and 3E+06 CAR+ cells /kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR19-BCMA dual-target CAR-T | Drug | This drug is CAR-T cell injection. CAR-T cells are based on the traditional CAR-T treatment, using cytokine combination amplification and improved transfection technology to change the activation mode of T cells. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and Severity of Adverse Events | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | in 3 months after CART infusion |
| Laboratoty tests | Abnormal results of laboratoty tests | in 3 months after CART infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Overall response rate (ORR) | Percentage of subjects who achieved minimal response (MR) or better according to IMWG Uniform Response Criteria for Multiple Myeloma as assessed by the investigators | Day28, Month2, Month3, Month6, Month12, Month18, Month24 after CAR-T infusion |
| Minimal Residual Disease (MRD) negative rate |
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Inclusion Criteria:
Subjects must satisfy all the following criteria to be enrolled in the study:
1. With Subjects' consent and signed informed consent, Subjects are willing and able to follow the planned visit, study treatment, laboratory examination and other test procedures; 2. Patients with relapsed / refractory multiple myeloma according to clinical diagnosis:
3. Age 18-70 years old, both male and female; 4. Subjects with physical fitness status of 0-2 in the Eastern Cooperative Oncology Group (ECOG) score; 5. The estimated survival time from the date of signing informed consent is more than 3 months; 6. Hgb ≥ 60g/L (transfusible); 7. Liver and kidney function and cardiopulmonary function meet the following requirements:
Creatinine ≤ 2 × ULN;
Left ventricular ejection fraction ≥ 50%;
Blood oxygen saturation >90%;
Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN; 8. Subjects with pregnancy plans must agree to take contraception before enrollment in the study and after six months of study duration; The investigator should be informed immediately if the subject is pregnant or suspected of pregnancy.
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Exclusion Criteria:
If any of the following criteria is met, you cannot be enrolled:
1. There were severe cardiac insufficiency and left ventricular ejection fraction <50%; 2. Have a history of severe lung function impairment disease; 3. Combined with other advanced malignant tumors; 4. It was complicated with serious infection and could not be effectively controlled; 5. Complicated with severe autoimmune disease or innate immune deficiency; 6. Active hepatitis (hepatitis B virus deoxyribonucleic acid [hbv-dna] or hepatitis C virus ribonucleic acid [hcv-rna] test results are higher than the lower limit of detection); 7. Human immunodeficiency virus (HIV) infection or known acquired immune deficiency syndrome (AIDS), or syphilis infection; 8. Have a history of severe allergy to biological products (including antibiotics); 9. One month after immunosuppressant withdrawal, patients with acute graft-versus-host response (GVHD) after allogeneic hematopoietic stem cell transplantation still exist; 10. There are other serious physical or mental diseases or abnormal laboratory tests that may increase the risk of participating in the study, or interfere with the results of the study, as well as patients who the investigator believes are not suitable for participating in this study; 11. Female patients (patients with fertility) are in pregnancy or lactation. Note: severe infection: refers to the infection with uncontrolled sepsis or infection focus, which can be enrolled after infection control.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Xu, MD | Contact | 13920593907 | +86 | ec@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yan Xu, MD | Institute of Hematology & Blood Diseases Hospital, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Hematology & Blood Diseases Hospital | Recruiting | Tianjin | Tianjin Municipality | China |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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Proportion of subjects who achieved MRD negative |
| Day28, Month2, Month3, Month6, Month12, Month18, Month24 after CAR-T infusion |
| Overall Survival (OS) | Time from CAR19-BCMA CAR-T infusion to time of death due to any cause | Minimum of 2 years post CAR-T infusion |
| Progression-free Survival (PFS) | Time from CAR19-BCMA CAR-T infusion to first documentation of progressive disease (PD), or death due to any cause, whichever occurs first | Minimum of 2 years post CAR-T infusion |
| Event-free Survival (EFS) | Time from CAR19-BCMA CAR-T infusion to time of disease progression, recurrence, death, etc | Minimum of 2 years post CAR-T infusion |
| Disease Control Rate (DCR) | disease control rate after CAR19-BCMA CAR-T infusion | at Day28, Month2, Month3 , Month6, Month12, Month18, Month24 after CAR-T infusion |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |