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| Name | Class |
|---|---|
| Gracell Biotechnology Ltd. | OTHER |
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The study is an early, open, single-centered trial. The purpose of this study is to evaluate the safety and persistence of BCMA/CD19 dual-target CAR-T cell immunotherapy in relapsed or refractory MM. The study will include 18 subjects to receive BCMA/CD19 dual-target CAR-T therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CAR-T treatment group | Experimental | The patients will receive one dose of BCMA/CD19 dual-target CAR-T. BCMA/CD19 dual-target CAR-T dosage ranges from 5×10^4 to 3×10^5 CAR+T/Kg. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BCMA/CD19 Dual-Target CAR-T | Biological | BCMA/CD19 Dual-Target CAR-T target both BCMA and CD19. The subjects will receive CAR-T as one dose. The dosage ranges from 5×10^4 to 3×10^5 CAR+T/Kg. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of treatment related AE | Adverse events(AEs) will be collected and graded according to ASTCT consensus(for Cytokine Release Syndrome, CRS and Immune Effector Cell-Associated Neurotoxicity Syndrome, ICANS) and CTCAE v5.0(for AE except CRS/ICANS ). | 2 years |
| Incidence of DLT | Dose-limiting toxicity (DLT) will be collected. DLT refers to toxicity that limit the process to continue increasing CAR-T dose. | 12 weeks |
| CAR copies concentration in peripheral blood | CAR copies in peripheral blood will be measured by qPCR and FCM. | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ORR | Objective response rate (ORR) will be calculated. ORR refers to the proportion between the number of subjects who are evaluated as PR or status better than PR and total number of subjects. | 2 years |
| DOR |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiequn Chen, Doctor | Contact | 84771857 | xiequnchen@fmmu.end.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xiequn Chen, Doctor | First affiliated hospital of air force military medical university(i.e., Xijing Hopital) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First affiliated hospital of air force military medical university(i.e., Xijing Hopital) | Recruiting | Xi’an | Shanxi | 710000 | 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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Duration of response (DOR) will be calculated. DOR refers to the time between the initial response (CR or PR) to therapy and evaluated as PD for the first time or death due to any reason.
| 2 years |
| PFS Rate | Progression free survival (PFS) rate will be calculated. PFS refers to the proportion between the number of subjects who are evaluated as PD or died and total number of subjects. | 2 years |
| OS Rate | Overall survival (OS) rate will be calculated. OS refers to the proportion between the number of subjects who died and total number of subjects. | 2 years |
| 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 |