BCMA Chimeric Antigen Receptor Expressing T Cells in Multiple Myeloma
A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With BCMA-positive Multiple Myeloma
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1 multiple-myeloma
Started Feb 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 15, 2017
CompletedFirst Submitted
Initial submission to the registry
March 15, 2017
CompletedFirst Posted
Study publicly available on registry
March 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedFebruary 27, 2019
March 1, 2018
2.5 years
March 15, 2017
February 25, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
6 months
Secondary Outcomes (3)
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
8 weeks
Duration of CAR-positive T cells in circulation
6 months
Total number of CAR-positive T cells infiltrated into lymphoma tissue
6 months
Study Arms (1)
anti-BCMA CAR-T
EXPERIMENTALAdministration of anti-BCMA:TCRζ-4-1-BB CAR-T cells to patients with multiple myeloma
Interventions
Retroviral vector-transduced autologous T cells to express anti-BCMA CAR
Eligibility Criteria
You may qualify if:
- 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
- Clinical performance status of ECOG score 0-4
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Henan Province of TCM
Zhengzhou, Henan, China
Related Publications (1)
Zhou L, Fu W, Wu S, Xu K, Qiu L, Xu Y, Yan X, Zhang Q, Zhang M, Wang L, Hong R, Chang AH, Yu J, Fu S, Kong D, Li L, Wang Y, Li Z, Jiang H, Huang J, Liu Z, Su N, Wei G, Hu Y, Huang H. Derivation and validation of a novel score for early prediction of severe CRS after CAR-T therapy in haematological malignancy patients: A multi-centre study. Br J Haematol. 2023 Aug;202(3):517-524. doi: 10.1111/bjh.18873. Epub 2023 May 16.
PMID: 37192741DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2017
First Posted
March 28, 2017
Study Start
February 15, 2017
Primary Completion
September 1, 2019
Study Completion
February 1, 2020
Last Updated
February 27, 2019
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will share