Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a single arm study to evaluate the safety and efficacy of CAR70-BCMA dual-target CAR-T cell therapy for relapsed and refractory plasma cell neoplasms.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| This is a single arm treatment of CAR 70-BCMA CAR-T cell | Experimental | CAR 70-BCMA CAR-T Therapy. Investigational product: CAR 70-BCMA CAR-T. Route of administration: Intravenous injection. Lymphodepleting chemotherapy regimen: A combination of fludarabine and cyclophosphamide will be administered prior to the infusion of CAR 70-BCMA CAR-T cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CAR 70-BCMA CAR-T | Genetic | Each subject will receive a single infusion of BCMA-CD70-CAR-T cells. A classic "3+3" dose escalation design will be employed. |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety of CAR70-BCMA dual-target chimeric antigen receptor T-cell therapy in patients with relapsed or refractory plasma cell neoplasms expressing CD70 and/or BCMA based on the incidence of treatment-emergent adverse events (AEs). | Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0 | Up to 3 years |
| To evaluate the safety of CAR70-BCMA CAR-T cells in the treatment of relapsed or refractory plasma cell neoplasms positive for CD70/BCMA based on the determination of the maximum tolerated dose (MTD). | Incidence of dose-limiting toxicity (DLT) | Up to 28 days after CAR-T treatment |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the efficacy of CAR70-BCMA CAR-T cells in the treatment of relapsed or refractory plasma cell neoplasms positive for CD70/BCMA based on the objective response rate (ORR). | Objective response rate (ORR) Description: For multiple myeloma (plasma cell neoplasms, plasma cell leukemia), the efficacy evaluation criteria refer to the Chinese Guidelines for the Diagnosis and Treatment of Multiple Myeloma (2024 Revision). ORR includes the proportion of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), and minimal response (MR). |
| Measure | Description | Time Frame |
|---|---|---|
| To explore the kinetics and clonal evolution of CAR70-BCMA CAR-T cells based on pharmacokinetics (assessing the persistence of CAR-T cells by measuring CAR-T cell counts in peripheral blood). | After infusion of CAR70-BCMA CAR-T cells, the CAR positivity rate in peripheral blood using flow cytometry and measuring CAR-T expression levels with qPCR. | Up to 12 months after CAR-T treatment |
Inclusion Criteria:
The subject or their legally authorized representative has provided written informed consent and is willing and able to comply with scheduled visits, study treatment, laboratory tests, and other study procedures
Diagnosis of relapsed or refractory plasma cell neoplasms, defined as follows:
Aged 18 to 75 years (inclusive), male or female
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
Life expectancy greater than 3 months from the date of informed consent
Hemoglobin (HGB) ≥ 60 g/L (transfusion permitted)
Adequate hepatic, renal, cardiac, and pulmonary function meeting the following criteria:
The subject agrees to use contraceptive measures from the time of signing the informed consent form until 1 year after CAR-T cell infusion
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hai Yi | Contact | 13699418229 | yihaimail@163.com |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| General Hospital of Western Theater Command of PLA | Recruiting | Chengdu | Chengdu | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D054219 | Neoplasms, Plasma Cell |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009370 | Neoplasms by Histologic Type |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Within 3 months following infusion of CAR70-BCMA CAR-T cells |
| D009369 | Neoplasms |