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| Name | Class |
|---|---|
| Shanghai AbelZeta Ltd. | INDUSTRY |
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This is a phase I/II, single-arm, open-lable study of autologous stem cell transplantation in combination with C-CAR088, an autologous BCMA CAR-T cell product, for patients with ulta high-risk multiple myeloma, defined as failed or unsatisfied responses to front line VRD-based treatment with or without the presence of multiple high-risk cytogenetic features.
Patients with ultra high-risk multiple myeloma will undergo leukapheresis, stem cell mobilization and collection (could omit if collected before screening), conditioning, ASCT and C-CAR088 infusion. Patients receive a single dose of C-CAR088 three days post-ASCT. Two conditioning protocols and two dose levels of C-CAR088 will be used based on the investigator's discretion. Patients will be evaluated closely for safety of efficacy during the first three months, then less frequently in the following months until 24 months post-ASCT.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ASCT and C-CAR088 | Experimental | Patients will undergo ASCT followed by C-CAR088 single dose infusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous hematopoietic stem cell transplantation | Procedure | Patients receive transplantation conditioning followed by autologous hematopoietic stem cell transplantation after successful stem cell mobilization and collection. If previously collected stem cells are available, no stem cell mobilization or collection is required, and patients will receive conditioning directly. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence rate and severity of adverse events (AE) | Incidence rate and severity of adverse events (AE) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival (PFS) | The time from the initiation of study treatment to the date of first documented disease progression or death | 24 months |
| MRD negativity rate | The percentage of patients who reached MRD negativity |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-drug (C-CAR088) antibody | The correlation between the presence of anti-drug (C-CAR088) antibody with the efficacy and prognosis | 24 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Xu, M.D., PH.D. | Contact | 86-022-23909171 | xuyan1@ihcams.ac.cn | |
| Dehui Zou, M.D., PH.D. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Dehui Zou, M.D., PH.D. | 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 | 300020 | 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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|
| C-CAR088 | Biological | C-CAR088 is an BCMA targeted Chimeric Antigen Receptor-T cell product. Patients will receive C-CAR088 single dose infusion 3 days after ASCT. The dose level of C-CAR088 will be determined by the investigator. |
|
| 24 months |
| Overall response rate (ORR) | The percentage of patients who reached PR, VGPR, CR or sCR as their best response | 24 months |
| Duration of response (DOR) | The time from the first documented PR or better response to progression or death, whichever occurs first | 24 months |
| Time to response (TTR) | The time between the initiation of study treatment until the the first documented PR or better response | 24 months |
| Overall Survival (OS) | OS is defined as the time from the initiation of study treatment to death from any cause | 24 months |
| Cmax (maximal plasma concentration) | Maximal plasma concentration of C-CAR088 in peripheral blood | 24 months |
| Tmax (Time to reach the maximal plasma conceration) | Time to reach the maximal plasma conceration of C-CAR088 in peripheral blood | 24 months |
| AUC0-28d (area under the curve from day 0-day 28) | Area under the curve of C-CAR088 in peripheral blood within 28 days post C-CAR088 infusion | 28 days post C-CAR088 infusion |
| Tlast (Time of last measurable observed concentration) | Time of last measurable observed concentration of C-CAR088 in peripheral blood | 24 months |
| 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 |