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This is a open-label to determine the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IM21 CAR-T cells | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IM21 CAR-T cells | Biological | IM21 CAR-T cells administrated in a dosage to be selected by physician from a specific range. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) | Incidence of treatment related AEs | Up to 28 days after CAR-T cell infusion |
| Persistence of CAR-T cells (cell counts and cell percentage in peripheral blood and bone marrow ) | The persistence over time of CAR T cells in the peripheral blood as determined by flow cytometry and qPCR. | Up to 24 weeks after CAR-T cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Objective response rate (ORR) | Up to 24 weeks after CAR-T cell infusion | |
| Overall survival (OS) | Up to 24 weeks after CAR-T cell infusion | |
| Minimal residual disease(MRD) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fei Wu | Contact | +8615801390058 | wufei@imunopharm.com |
| Name | Affiliation | Role |
|---|---|---|
| Xiaojing Yan, M.D. | First Hospital of China Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital of China Medical University | Recruiting | Shenyang | Liaoning | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37192741 | Derived | Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16. |
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| Up to 24 weeks after CAR-T cell infusion |
| Duration of Response (DOR) | Up to 24 weeks after CAR-T cell infusion |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| 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 |
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