Back to resultsBCMA Chimeric Antigen Receptor Expressing T Cells in Multiple Myeloma
Primary Purpose
Multiple Myeloma
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Anti-BCMA CAR-T cells
Fludarabine
Cyclophosphamide
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Myeloma
Eligibility Criteria
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
- 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.
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
Sites / Locations
- Henan Province of TCMRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
anti-BCMA CAR-T
Arm Description
Administration of anti-BCMA:TCRζ-4-1-BB CAR-T cells to patients with multiple myeloma
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Duration of CAR-positive T cells in circulation
Duration of CAR-positive T cells in circulation
Total number of CAR-positive T cells infiltrated into lymphoma tissue
Total number of CAR-positive T cells infiltrated into lymphoma tissue
Full Information
NCT ID
NCT03093168
First Posted
March 15, 2017
Last Updated
February 25, 2019
Sponsor
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Collaborators
Hrain Biotechnology Co., Ltd., First Affiliated Hospital of Wenzhou Medical University, Shanghai Changzheng Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03093168
Brief Title
BCMA Chimeric Antigen Receptor Expressing T Cells in Multiple Myeloma
Official Title
A Phase I Clinical Trial of T-Cells Targeting B-Cell Maturation Antigen for Subjects With BCMA-positive Multiple Myeloma
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 15, 2017 (Actual)
Primary Completion Date
September 2019 (Anticipated)
Study Completion Date
February 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Second Affiliated Hospital of Henan University of Traditional Chinese Medicine
Collaborators
Hrain Biotechnology Co., Ltd., First Affiliated Hospital of Wenzhou Medical University, Shanghai Changzheng Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
Primary Objectives
To determine the feasibility ad safety of BCMA CAR-T cells in treating patients with multiple myeloma.
To determine in vivo dynamics and persistency of BCMA CAR-T cells.
To access the efficacy of BCMA CAR-T cells in patients with multiple myeloma.
Secondary Objectives
To assess the bone marrow and tumor migration of BCMA CAR-T cells.
To investigate the tumor killing capability of BCMA CAR-T cells in vitro
To investigate the possibility of host immune response to the mouse derived BCMA scFv, and evaluate its correlation to CAR-T persistence.
To correlate the subsets and differentiation of BCMA CAR-T cells to observed anti-tumor efficacy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
anti-BCMA CAR-T
Arm Type
Experimental
Arm Description
Administration of anti-BCMA:TCRζ-4-1-BB CAR-T cells to patients with multiple myeloma
Intervention Type
Biological
Intervention Name(s)
Anti-BCMA CAR-T cells
Intervention Description
Retroviral vector-transduced autologous T cells to express anti-BCMA CAR
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
dose: 25mg/m2/d
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Dose: 40mg/kg
Primary Outcome Measure Information:
Title
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Description
Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Description
Overall complete remission rate defined by the standard response criteria for malignant lymphoma for each arm
Time Frame
8 weeks
Title
Duration of CAR-positive T cells in circulation
Description
Duration of CAR-positive T cells in circulation
Time Frame
6 months
Title
Total number of CAR-positive T cells infiltrated into lymphoma tissue
Description
Total number of CAR-positive T cells infiltrated into lymphoma tissue
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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.
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
Facility Information:
Facility Name
Henan Province of TCM
City
Zhengzhou
State/Province
Henan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhi Cheng, M.D.
Phone
+(86)-139-3852-6995
Email
clinicaltrials.chengzhi@outlook.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
BCMA Chimeric Antigen Receptor Expressing T Cells in Multiple Myeloma
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