A Phase I Study of Adoptive Immunotherapy for Advanced B-Cell Maturation Antigen (BCMA)+ Multiple Myeloma With Autologous CD4+ and CD8+ T Cells Engineered to Express a BCMA-Specific Chimeric Antigen Receptor
Phase: PHASE1
Conditions: Recurrent Plasma Cell Myeloma, Refractory Plasma Cell Myeloma
Sponsor: Fred Hutchinson Cancer Center

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IRO received 09/15/20
FHCRC IRB Approval  
10/07/2020 
Document Released Date
9762
IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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Printed on 4/7/2022

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Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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Printed on 4/7/2022
Printed on 4/7/2022

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IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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Printed on 4/7/2022
Printed on 4/7/2022

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Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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9762
IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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9762
IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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9762
IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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9762
IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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Printed on 4/7/2022
Printed on 4/7/2022

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Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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Dose level
BCMA CAR T Cell Dose
0
   25 x 106 EGFRt+ cells
1 (Starting dose level)
50 x 106 EGFRt+ cells
2
150 x 106 EGFRt+cells
3
300 x 106 EGFRt+ cells
4
450 x 106 EGFRt+ cells
5
800 x 106 EGFRt+ cells
Table 5.1 Dose levels to be used during dose escalation
[EGFRt is co-expressed in the CAR vector and serves as a transduc-
tion marker to determine the number of CAR-T cells in the cell prod-
uct to define cell dose.]
9762
IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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Printed on 4/7/2022
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Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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Printed on 4/7/2022
Printed on 4/7/2022

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Printed on 4/7/2022

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Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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Printed on 4/7/2022
Printed on 4/7/2022

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Printed on 4/7/2022
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Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

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9762
IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

3URWRFRO
3DJHRI
9762
IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

3URWRFRO
3DJHRI
9762
IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022

3URWRFRO
3DJHRI
9762
IRB Approved 
Document Release Date: 10/07/2020
Printed on 4/7/2022
Printed on 4/7/2022