Multiple Myeloma
Conditions
Keywords
BCMA, CAR-T, multiple myeloma, Relapsed /Refractory
Brief summary
The goal of this clinical trial is to study the feasibility and efficacy of anti-B-Cell Maturation Antigen (BCMA) expressing T cells in treating patients with multiple myeloma.
Detailed description
Participants with BCMA-positive relapsed/refractory multiple myeloma can participate if all eligibility criteria are met. Tests required to determine eligibility include disease assessments, a physical exam, Electrocardiograph, CT/MRI/PET, and blood draws. Participants receive chemotherapy prior to the infusion of BCMA CAR+ T cells. After the infusion, participants will be followed for side effects and effect of BCMA CAR+ T cells. Study procedures may be performed while hospitalized.
Interventions
BIOLOGICALAnti-BCMA CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-BCMA CAR
DRUGFludarabine
30mg/m2/d
DRUGCyclophosphamide
300mg/m2/d
DRUGImmune inhibitors
Immune inhibitors
Sponsors
Shanghai Changzheng Hospital
Hrain Biotechnology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Expected survival \> 12 weeks * Diagnosis of Multiple Myeloma by MWG criteria 20 * Patients previously received at least 3 different prior treatment regimens for multiple myeloma, including alkylating agent, protein inhibitors, and immunomodulator, and have disease progression in the past 60 days * Important organs function enough to tolerate this therapy * At least 90 days after stem cell transplantation * 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 * 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 * Suffering severe cardiovascular or respiratory disease * Poorly controlled hypertension * Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment * A history of mental illness and poorly controlled * Screening showing target cell transduction efficacy is lower than 30%, or T cell proliferation is not enough for infusion (less than 5 fold) * Occurrence of unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolic events 30 days prior to assignment * Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy * 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 * Active systemic infections or uncontrolled infection within 14 days prior enrollment * 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 5.0 | 6 months | Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm | 8 weeks | Overall complete remission rate defined by the standard response criteria for malignant lymphoma 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 ContactXuedong Sun
Backup ContactWeijun Fu
Outcome results
None listed