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This is an investigator-initiated, single-center, early-phase clinical study comprising dose escalation and dose expansion phases, designed to evaluate the safety and efficacy of IMV102 in subjects with relapsed/refractory multiple myeloma (RRMM). Eligible subjects will receive an infusion of IMV102 injection. Blood and urine samples will be collected before and after infusion for pharmacokinetic, pharmacodynamic, immunogenicity, and safety assessments.
Tumor response will be evaluated according to the International Myeloma Working Group (IMWG) uniform response criteria (2016). Assessments will be performed at baseline, and then at Day 28 post-infusion, Month 2, Month 3, and subsequently every 3 months from Month 3 to Month 24, until the subject completes the 24-month follow-up period, experiences disease progression (PD)/relapse, initiates new anti-tumor therapy, dies, or withdraws from the study, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMV102 treatment group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMV102 treatment | Biological | Eligible patients with relapsed/refractory multiple myeloma will receive an infusion of IMV102 injection, and the safety and efficacy of IMV102 injection will be evaluated within 24 months post-infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of IMV102 injection in patients with relapsed/refractory multiple myeloma | Incidence of adverse events and its severity after IMV102 injection treatment | 24 months post IMV102 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of pharmacokinetic (about Cmax) | The maximum concentration of CAR-T cells in peripheral blood after administration (Cmax) | 24 months post IMV102 infusion |
| Assessment of pharmacokinetic (about Tmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juan Du, MD | Contact | 15800706091 | Juan_du@live.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing GoBroad Boren Hospital | Recruiting | Beijing | 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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The time to reach the maximum concentration (Tmax)
| 24 months post IMV102 infusion |
| Assessment of pharmacokinetic (about AUC0-28d) | The area under the CAR-T concentration versus time curve (AUC) for 28 days after IMV102 administration | From first dose of IMV102 to 28 days after IMV102 administration |
| Assessment of pharmacokinetic (about AUC0-90d) | The area under the CAR-T concentration versus time curve (AUC) for 90 days after IMV102 administration | From first dose of IMV102 to 90 days after IMV102 administration |
| Efficacy of IMV102 injection | Overall response rate after IMV102 infusion | about 2 years |
| Efficacy of IMV102 injection | Overall survival after IMV102 infusion | about 2 years |
| Efficacy of IMV102 injection | Progress-free survival after IMV102 infusion | about 2 years |
| The second affiliated hospital of Chongqing medical university | Not yet recruiting | Chongqing | China |
|
| Renji Hospital, Shanghai Jiao Tong University School of Medicine | Not yet recruiting | Shanghai | China |
|
| Zhengzhou Yihe Hospital | Not yet recruiting | Zhengzhou | China |
|
| 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 |