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This is an open-label, Phase 1 dose exploration study to evaluate the safety and tolerability and to determine recommended Phase 2 dose(s) of JWCAR129, a CAR T-cell product that targets B-cell maturation antigen (BCMA), in adult subjects with relapsed and/or refractory multiple myeloma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JWCAR129 | Experimental | Subjects will receive a course of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by a single dose of JWCAR129 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JWCAR129 | Biological | Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR129. During JWCAR129 production, participants may receive bridging chemotherapy for disease control. Following successful generation of JWCAR129 product, participants will receive a course of lymphodepleting chemotherapy followed by one dose of JWCAR129 administered intravenously (IV). |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of dose-limiting toxicities (DLTs) | Proportion of subjects with adverse events meeting DLT criteria | 28 days |
| Incidence and severity of adverse events | Proportion of subjects with adverse events overall and by severity grade | 2 years |
| Incidence and severity of clinically significant laboratory abnormalities | Proportion of subjects with clinically significant laboratory abnormalities overall and by severity grade | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax | Maximum concentration (Cmax) of JWCAR129 in the blood | 2 years |
| Tmax | Time to maximum concentration (Tmax) of JWCAR129 in the blood |
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Inclusion Criteria:
18 years old and above.
Signed the Informed Consent Form.
Diagnosis of multiple myeloma (MM) with relapsed and/or refractory disease. Subjects must have received at least 3 prior anti-myeloma treatment regimens (note: induction with or without bone marrow transplant and with or without maintenance therapy is considered one regimen). Subjects must be refractory to the last anti-myeloma treatment regimen prior to entering the study.
Subjects who were not candidates to receive one or more of the above treatments (ie, contraindicated) are eligible; the reason for not receiving treatment must be clearly documented in the case report form.
Subjects must have measurable disease.
Subject must be willing to provide fresh bone marrow biopsy samples during Screening (and prior to study treatment, if required).
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Adequate renal, bone marrow, hepatic, pulmonary, and cardiac function
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital, Soochow University | Recruiting | Suzhou | Jiangsu | 215000 | China |
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| 2 years |
| AUC | Area under the concentration vs time curve (AUC) of JWCAR129 in the blood | 2 years |
| Duration of persistence | Duration of persistence of JWCAR129 CAR T cells in the blood | 2 years |
| Overall response rate | Proportion of subjects with a partial response (PR) or better by IMWG criteria | 2 years |
| CR rate | Proportion of subjects with a CR by IMWG criteria | 2 years |