BCMA Chimeric Antigen Receptor Expressing T Cells Therapy for Relapsed/Refractory Multiple Myeloma
NCT ID: NCT03943472
Last Updated: 2021-08-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
EARLY_PHASE1
10 participants
INTERVENTIONAL
2019-07-08
2022-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
BCMA Chimeric Antigen Receptor Expressing T Cells in Multiple Myeloma
NCT03093168
Study of BCMA CAR-T in Multiple Myeloma
NCT03322735
Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma
NCT03338972
Human BCMA Targeted T Cells Injection（BCMA CAR-T）for Subjects With R/R MM
NCT05594797
Human BCMA Targeted T Cells Injection Therapy for BCMA-positive Relapsed/Refractory Multiple Myeloma
NCT04003168
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
anti-BCMA CAR-T
Administration of anti-BCMA CAR-T cells to patients with multiple myeloma
Anti-BCMA CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-BCMA CAR
Fludarabine
30mg/m2/d
Cyclophosphamide
300mg/m2/d
anti-BCMA CAR-T+ Immune inhibitors
Administration of anti-BCMA CAR-T cells + Immune inhibitors to patients with multiple myeloma
Anti-BCMA CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-BCMA CAR
Fludarabine
30mg/m2/d
Cyclophosphamide
300mg/m2/d
Immune inhibitors
Immune inhibitors
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Anti-BCMA CAR-T cells
Retroviral vector-transduced autologous T cells to express anti-BCMA CAR
Fludarabine
30mg/m2/d
Cyclophosphamide
300mg/m2/d
Immune inhibitors
Immune inhibitors
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Shanghai Changzheng Hospital
OTHER
Hrain Biotechnology Co., Ltd.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
anti-BCMA CART
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.