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 |
|---|---|
| CARsgen Therapeutics Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This is an open-label, single arm study to evaluate the safety and tolerability of treatment with CT0594CP CAR-T Cells in patients with relapsed and/or refractory multiple myeloma or Plasma Cell Leukemia
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT0594CP CAR-T Cells[BCMA-UCAR-T(CT0594) and CD9-UCAR-T(CT7590)] | Experimental | CT0594CP |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CT0594CP | Biological | Cell injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerabilitydose limiting toxicity | Safety and tolerability: dose limiting toxicity [Time Frame: 21-28 days post administration of CT0594CP ] | 21-28 days |
Not provided
Not provided
Inclusion Criteria:
4) Circulating plasma cells ≥2% 6. Expected survival > 12 weeks. 7. Eastern Cooperative Oncology Group (ECOG) scores 0-1. 8. Subjects should have adequate function in hemostatic and liver and kidney. 9. Women of childbearing age must undergo a serum pregnancy test with negative results at screening and before lymphodepletion and be willing to use an effective and reliable method of contraception for at least 1 year after study treatment. All female subjects are prohibited from egg donation within 1 year after study treatment.
10. Men must be willing to use an effective and reliable method of contraception for at least 1 year after study treatment if they have sexual activity with women of childbearing potential. All male subjects are prohibited from sperm donation within 1 year after study treatment .
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chengcheng Fu | Contact | 13962191404 | fuzhengzheng@suda.edu.cn | |
| Jingjing Shang | Contact | 180 1356 8250 | rebeccasjj@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
Not provided
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| D007952 | Leukemia, Plasma Cell |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| D007938 | Leukemia |