Multiple Myeloma in Relapse, Multiple Myeloma Progression
Conditions
Brief summary
The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory multiple myeloma.
Detailed description
Primary Objectives 1\. To determine the feasibility ad safety of anti-CD19/BCMA CAR-T cells in treating patients with BCMA-positive multiple myeloma. Secondary Objectives 1. To access the efficacy of anti-CD19/BCMA CAR-T cells in patients with multiple myeloma. 2. To determine in vivo dynamics and persistency of anti-CD19/BCMA CAR-T cells.
Interventions
BIOLOGICALanti-CD19/BCMA CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs
DRUGFludarabine
30mg/m2/d
DRUGCyclophosphamide
300mg/m2/d
Sponsors
Hrain Biotechnology
Shanghai East Hospital
Peng Liu
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Expected survival \> 12 weeks * Diagnosis of Multiple Myeloma by IMWG updated criteria (2014) * Pathology demonstrated that BCMA-poitive malignant plasma cells exited in bone marrow or plamacytoma * Exited measurable lesions and in accordance with one of the following test indicators: serum M protein≥1 g/dl; urine M protein≥200 mg/24h; serum free light chain≥10 mg/dl; diagnosis of plasmacytoma by biopsy * The criteria for relapsed and refractory multiple myeloma: patients previously received at least 3 different prior treatment regimens for multiple myeloma, including protein inhibitors (eg: Bortezomib), and immunomodulator (eg: Revlimid), and have disease progression in the past 60 days * At least 90 days after stem cell transplantation * Clinical performance status of ECOG score 0-2 * Creatinine≤2.0 mg/dl * Bilirubin≤2.0 mg/dl * The ALT/AST value is lower than 2.5-fold of normal value * Accessible to intravenous injection, and no white blood cell collection contraindications * Sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the CTL infusion. Male partner should use a condom * 5mg/day dose of Prednisone or other equivalent steroid hormone drugs (eg: Dexamethasone) were not used for two weeks before apheresis and CAR-T infusion * Able to understand and sign the Informed Consent Document.
Exclusion criteria
* Patients with symptoms of central nervous system * Patients with second malignancies in addition to multiple myeloma * Active hepatitis B or C, HIV infections * Any other active diseases could affect the enrollment of this trial * Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment * Patients with organ failure * Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy * A history of mental illness and poorly controlled * Women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. Women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion * Patients who are accounted by researchers to be not appropriate for this test * Subjects suffering disease affects the understanding of informed consent or complying with study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 | 6 months | Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall remission rate defined by the standard response criteria for myeloma for each arm | 8 weeks | Overall remission rate defined by the standard response criteria for myeloma for each arm |
| Duration of CAR-positive T cells in circulation | 6 months | Duration of CAR-positive T cells in circulation |
Countries
China
Contacts
Primary ContactZheng Wei, M.D.
Outcome results
None listed