Difference between revisions of "Ciltacabtagene autoleucel (Carvykti)"

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From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ciltacabtagene-autoleucel NCI Drug Dictionary]: A preparation of autologous T lymphocytes that are transduced, ex vivo, with a lentiviral vector expressing a chimeric antigen receptor (CAR) containing two bispecific anti-B-cell maturation antigen (BCMA) variable fragments of llama heavy-chain murine antibodies fused to the signaling domain of 4-1BB (CD137), with potential immunostimulating and antineoplastic activities. The antigen-binding region of the CAR is a non-scFv structure targeting two distinct regions of BCMA. Upon intravenous administration back into the patient, the autologous bi-epitope BCMA-targeted CAR T cells JNJ-68284528 are directed to cells expressing BCMA, bind to two different epitopes on BCMA and induce selective toxicity in BCMA-expressing tumor cells.  
 
From the [https://www.cancer.gov/publications/dictionaries/cancer-drug/def/ciltacabtagene-autoleucel NCI Drug Dictionary]: A preparation of autologous T lymphocytes that are transduced, ex vivo, with a lentiviral vector expressing a chimeric antigen receptor (CAR) containing two bispecific anti-B-cell maturation antigen (BCMA) variable fragments of llama heavy-chain murine antibodies fused to the signaling domain of 4-1BB (CD137), with potential immunostimulating and antineoplastic activities. The antigen-binding region of the CAR is a non-scFv structure targeting two distinct regions of BCMA. Upon intravenous administration back into the patient, the autologous bi-epitope BCMA-targeted CAR T cells JNJ-68284528 are directed to cells expressing BCMA, bind to two different epitopes on BCMA and induce selective toxicity in BCMA-expressing tumor cells.  
  
==Preliminary data==
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==Diseases for which it is used==
==[[Multiple myeloma]]==
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*[[Multiple myeloma]]
#'''CARTITUDE-1:''' Berdeja JG, Madduri D, Usmani SZ, Jakubowiak A, Agha M, Cohen AD, Stewart AK, Hari P, Htut M, Lesokhin A, Deol A, Munshi NC, O'Donnell E, Avigan D, Singh I, Zudaire E, Yeh TM, Allred AJ, Olyslager Y, Banerjee A, Jackson CC, Goldberg JD, Schecter JM, Deraedt W, Zhuang SH, Infante J, Geng D, Wu X, Carrasco-Alfonso MJ, Akram M, Hossain F, Rizvi S, Fan F, Lin Y, Martin T, Jagannath S. Ciltacabtagene autoleucel, a B-cell maturation antigen-directed chimeric antigen receptor T-cell therapy in patients with relapsed or refractory multiple myeloma (CARTITUDE-1): a phase 1b/2 open-label study. Lancet. 2021 Jun 24:S0140-6736(21)00933-8. Epub ahead of print. [https://doi.org/10.1016/s0140-6736(21)00933-8 link to original article] [https://pubmed.ncbi.nlm.nih.gov/34175021/ PubMed] NCT03548207
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==History of changes in FDA indication==
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*2/28/2022: Approved for the treatment of adult patients with relapsed or refractory [[multiple myeloma]] after four or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. ''(Based on CARTITUDE-1)''
  
 
==Also known as==
 
==Also known as==
 
*'''Code names:''' JNJ-68284528, LCAR-B38M
 
*'''Code names:''' JNJ-68284528, LCAR-B38M
 
*'''Generic name:''' cilta-cel
 
*'''Generic name:''' cilta-cel
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*'''Brand name:''' Carvykti
  
 
==References==
 
==References==
  
 
[[Category:Chimeric antigen receptor T-cells]]
 
[[Category:Chimeric antigen receptor T-cells]]
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[[Category:Anti-BCMA CAR-T]]
 
[[Category:Intravenous medications]]
 
[[Category:Intravenous medications]]
 
[[Category:Multiple myeloma medications]]
 
[[Category:Multiple myeloma medications]]
[[Category:Investigational drugs]]
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[[Category:FDA approved in 2022]]

Revision as of 15:14, 3 March 2022

Mechanism of action

From the NCI Drug Dictionary: A preparation of autologous T lymphocytes that are transduced, ex vivo, with a lentiviral vector expressing a chimeric antigen receptor (CAR) containing two bispecific anti-B-cell maturation antigen (BCMA) variable fragments of llama heavy-chain murine antibodies fused to the signaling domain of 4-1BB (CD137), with potential immunostimulating and antineoplastic activities. The antigen-binding region of the CAR is a non-scFv structure targeting two distinct regions of BCMA. Upon intravenous administration back into the patient, the autologous bi-epitope BCMA-targeted CAR T cells JNJ-68284528 are directed to cells expressing BCMA, bind to two different epitopes on BCMA and induce selective toxicity in BCMA-expressing tumor cells.

Diseases for which it is used

History of changes in FDA indication

  • 2/28/2022: Approved for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. (Based on CARTITUDE-1)

Also known as

  • Code names: JNJ-68284528, LCAR-B38M
  • Generic name: cilta-cel
  • Brand name: Carvykti

References