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This is an open label, single-arm, Phase 2 study to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide.
This open label, single-arm, Phase 2 study aims to evaluate the efficacy and safety of Anti-FcRL5 CAR-T in subjects with relapsed and refractory multiple myeloma. A leukapheresis procedure will be performed to manufacture. Anti-FcRL5 chimeric antigen receptor (CAR) modified T cells. Prior to Anti-FcRL5 infusion subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide. After infusion, the investigators will observe the characteristics of dose limited toxicity (DLT), and determine the maximum tolerable agent MTD and rp2d were confirmed. To provide basis for the dosage and treatment plan of cell products in follow-up clinical trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| anti FcRL5 CAR-T | Experimental | anti-FcRL5 autologous CAR T cells will be infused at a dose ranging from 1 - 2 x 10^6/kg CAR+ T cells after receiving lymphodepleting chemotherapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| anti-FcRL5 CAR-T | Drug | anti-FcRL5 autologous CAR T cells will be infused at a dose ranging from 1 - 2 x 10^6/kg CAR+ T cells after receiving lymphodepleting chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Adverse events assessed according to NCI-CTCAE v5.0 | Baseline up to 28 days after CAR-T cells infusion |
| Measure | Description | Time Frame |
|---|---|---|
| overall response rate (ORR) | Assessment of ORR at Month 6, 12, 18 and 24 | Month 6, 12, 18 and 24 |
| complete response (CR) | Assessment of CR at Month 6, 12, 18 and 24 |
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Inclusion Criteria:
The set subject inclusion criteria include multiple documents of multiple myeloma, no effective treatment options (e. g. autologous or allogeneic stem cell transplantation) and limited outcome (<2 years) with existing therapies, as follows:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kailin Xu, MD.,PD. | Contact | 15162166166 | PD | lihmd@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Kailin Xu, MD.,PD. | The Affiliated Hospital oh Xuzhou Medical University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The affiliated hospital of Xuzhou Medical University | Recruiting | Xuzhou | Jiangsu | 221006 | 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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| Month 6, 12, 18 and 24 |
| Overall survival (OS) | Assessment of OS at Month 6, 12, 18 and 24 | Month 6, 12, 18 and 24 |
| Event-free survival (EFS) | Assessment of EFS at Month 6, 12, 18 and 24 | Month 6, 12, 18 and 24 |
| 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 |