Population‐based cellular kinetic characterization of ciltacabtagene autoleucel in subjects with relapsed or refractory multiple myeloma
The aims of this work were to develop a population pharmacokinetic (PK) model for chimeric antigen receptor (CAR) transgene after single intravenous infusion administration of ciltacabtagene autoleucel in adult patients with relapsed or refractory multiple myeloma. CAR transgene level in blood were...
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| Published in | Clinical and translational science Vol. 15; no. 12; pp. 3000 - 3011 |
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| Main Authors | , , , , , , |
| Format | Journal Article |
| Language | English |
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United States
John Wiley & Sons, Inc
01.12.2022
John Wiley and Sons Inc Wiley |
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| Online Access | Get full text |
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| Abstract | The aims of this work were to develop a population pharmacokinetic (PK) model for chimeric antigen receptor (CAR) transgene after single intravenous infusion administration of ciltacabtagene autoleucel in adult patients with relapsed or refractory multiple myeloma. CAR transgene level in blood were measured by quantitative polymerase chain reaction (qPCR) from 97 subjects in a phase Ib/II CARTITUDE‐1 study (NCT03548207), with a targeted cilta‐cel dose of 0.75 × 106 (range 0.5–1.0 × 106) CAR positive viable T‐cells per kg body weight. The population PK model development was primarily guided by the current mechanistic understanding of CAR‐T kinetics and the principles of building a parsimonious model. Cilta‐cel PK was adequately described by a two‐compartment model (with a fast and a slow apparent decline rate from each compartment, respectively) and a chain of four transit compartments with a lag time empirically representing the process from infused CAR‐T cell to measurable CAR transgene. No apparent relationship was observed between cilta‐cel dose (i.e., the actual number of CAR positive viable T‐cells infused), given the narrow dose range, and the observed transgene level. Based on covariate search and subgroup analysis of maximum systemic CAR transgene level (Cmax) and area under curve from the first dose to day 28 (AUC0–28d), none of the investigated subjects' demographics, baseline characteristics, and manufactured product characteristics had significant effects on cilta‐cel PK. The developed model is deemed robust and adequate for enabling subsequent exposure‐safety and exposure‐efficacy analyses. |
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| AbstractList | The aims of this work were to develop a population pharmacokinetic (PK) model for chimeric antigen receptor (CAR) transgene after single intravenous infusion administration of ciltacabtagene autoleucel in adult patients with relapsed or refractory multiple myeloma. CAR transgene level in blood were measured by quantitative polymerase chain reaction (qPCR) from 97 subjects in a phase Ib/II CARTITUDE-1 study (NCT03548207), with a targeted cilta-cel dose of 0.75 × 106 (range 0.5–1.0 × 106) CAR positive viable T-cells per kg body weight. The population PK model development was primarily guided by the current mechanistic understanding of CAR-T kinetics and the principles of building a parsimonious model. Cilta-cel PK was adequately described by a two-compartment model (with a fast and a slow apparent decline rate from each compartment, respectively) and a chain of four transit compartments with a lag time empirically representing the process from infused CAR-T cell to measurable CAR transgene. No apparent relationship was observed between cilta-cel dose (i.e., the actual number of CAR positive viable T-cells infused), given the narrow dose range, and the observed transgene level. Based on covariate search and subgroup analysis of maximum systemic CAR transgene level (Cmax) and area under curve from the first dose to day 28 (AUC0–28d), none of the investigated subjects' demographics, baseline characteristics, and manufactured product characteristics had significant effects on cilta-cel PK. The developed model is deemed robust and adequate for enabling subsequent exposure-safety and exposure-efficacy analyses. The aims of this work were to develop a population pharmacokinetic (PK) model for chimeric antigen receptor (CAR) transgene after single intravenous infusion administration of ciltacabtagene autoleucel in adult patients with relapsed or refractory multiple myeloma. CAR transgene level in blood were measured by quantitative polymerase chain reaction (qPCR) from 97 subjects in a phase Ib/II CARTITUDE-1 study (NCT03548207), with a targeted cilta-cel dose of 0.75 × 10 (range 0.5-1.0 × 10 ) CAR positive viable T-cells per kg body weight. The population PK model development was primarily guided by the current mechanistic understanding of CAR-T kinetics and the principles of building a parsimonious model. Cilta-cel PK was adequately described by a two-compartment model (with a fast and a slow apparent decline rate from each compartment, respectively) and a chain of four transit compartments with a lag time empirically representing the process from infused CAR-T cell to measurable CAR transgene. No apparent relationship was observed between cilta-cel dose (i.e., the actual number of CAR positive viable T-cells infused), given the narrow dose range, and the observed transgene level. Based on covariate search and subgroup analysis of maximum systemic CAR transgene level (C ) and area under curve from the first dose to day 28 (AUC ), none of the investigated subjects' demographics, baseline characteristics, and manufactured product characteristics had significant effects on cilta-cel PK. The developed model is deemed robust and adequate for enabling subsequent exposure-safety and exposure-efficacy analyses. The aims of this work were to develop a population pharmacokinetic (PK) model for chimeric antigen receptor (CAR) transgene after single intravenous infusion administration of ciltacabtagene autoleucel in adult patients with relapsed or refractory multiple myeloma. CAR transgene level in blood were measured by quantitative polymerase chain reaction (qPCR) from 97 subjects in a phase Ib/II CARTITUDE‐1 study (NCT03548207), with a targeted cilta‐cel dose of 0.75 × 10 6 (range 0.5–1.0 × 10 6 ) CAR positive viable T‐cells per kg body weight. The population PK model development was primarily guided by the current mechanistic understanding of CAR‐T kinetics and the principles of building a parsimonious model. Cilta‐cel PK was adequately described by a two‐compartment model (with a fast and a slow apparent decline rate from each compartment, respectively) and a chain of four transit compartments with a lag time empirically representing the process from infused CAR‐T cell to measurable CAR transgene. No apparent relationship was observed between cilta‐cel dose (i.e., the actual number of CAR positive viable T‐cells infused), given the narrow dose range, and the observed transgene level. Based on covariate search and subgroup analysis of maximum systemic CAR transgene level ( C max ) and area under curve from the first dose to day 28 (AUC 0–28d ), none of the investigated subjects' demographics, baseline characteristics, and manufactured product characteristics had significant effects on cilta‐cel PK. The developed model is deemed robust and adequate for enabling subsequent exposure‐safety and exposure‐efficacy analyses. Abstract The aims of this work were to develop a population pharmacokinetic (PK) model for chimeric antigen receptor (CAR) transgene after single intravenous infusion administration of ciltacabtagene autoleucel in adult patients with relapsed or refractory multiple myeloma. CAR transgene level in blood were measured by quantitative polymerase chain reaction (qPCR) from 97 subjects in a phase Ib/II CARTITUDE‐1 study (NCT03548207), with a targeted cilta‐cel dose of 0.75 × 106 (range 0.5–1.0 × 106) CAR positive viable T‐cells per kg body weight. The population PK model development was primarily guided by the current mechanistic understanding of CAR‐T kinetics and the principles of building a parsimonious model. Cilta‐cel PK was adequately described by a two‐compartment model (with a fast and a slow apparent decline rate from each compartment, respectively) and a chain of four transit compartments with a lag time empirically representing the process from infused CAR‐T cell to measurable CAR transgene. No apparent relationship was observed between cilta‐cel dose (i.e., the actual number of CAR positive viable T‐cells infused), given the narrow dose range, and the observed transgene level. Based on covariate search and subgroup analysis of maximum systemic CAR transgene level (Cmax) and area under curve from the first dose to day 28 (AUC0–28d), none of the investigated subjects' demographics, baseline characteristics, and manufactured product characteristics had significant effects on cilta‐cel PK. The developed model is deemed robust and adequate for enabling subsequent exposure‐safety and exposure‐efficacy analyses. The aims of this work were to develop a population pharmacokinetic (PK) model for chimeric antigen receptor (CAR) transgene after single intravenous infusion administration of ciltacabtagene autoleucel in adult patients with relapsed or refractory multiple myeloma. CAR transgene level in blood were measured by quantitative polymerase chain reaction (qPCR) from 97 subjects in a phase Ib/II CARTITUDE-1 study (NCT03548207), with a targeted cilta-cel dose of 0.75 × 106 (range 0.5-1.0 × 106 ) CAR positive viable T-cells per kg body weight. The population PK model development was primarily guided by the current mechanistic understanding of CAR-T kinetics and the principles of building a parsimonious model. Cilta-cel PK was adequately described by a two-compartment model (with a fast and a slow apparent decline rate from each compartment, respectively) and a chain of four transit compartments with a lag time empirically representing the process from infused CAR-T cell to measurable CAR transgene. No apparent relationship was observed between cilta-cel dose (i.e., the actual number of CAR positive viable T-cells infused), given the narrow dose range, and the observed transgene level. Based on covariate search and subgroup analysis of maximum systemic CAR transgene level (Cmax ) and area under curve from the first dose to day 28 (AUC0-28d ), none of the investigated subjects' demographics, baseline characteristics, and manufactured product characteristics had significant effects on cilta-cel PK. The developed model is deemed robust and adequate for enabling subsequent exposure-safety and exposure-efficacy analyses.The aims of this work were to develop a population pharmacokinetic (PK) model for chimeric antigen receptor (CAR) transgene after single intravenous infusion administration of ciltacabtagene autoleucel in adult patients with relapsed or refractory multiple myeloma. CAR transgene level in blood were measured by quantitative polymerase chain reaction (qPCR) from 97 subjects in a phase Ib/II CARTITUDE-1 study (NCT03548207), with a targeted cilta-cel dose of 0.75 × 106 (range 0.5-1.0 × 106 ) CAR positive viable T-cells per kg body weight. The population PK model development was primarily guided by the current mechanistic understanding of CAR-T kinetics and the principles of building a parsimonious model. Cilta-cel PK was adequately described by a two-compartment model (with a fast and a slow apparent decline rate from each compartment, respectively) and a chain of four transit compartments with a lag time empirically representing the process from infused CAR-T cell to measurable CAR transgene. No apparent relationship was observed between cilta-cel dose (i.e., the actual number of CAR positive viable T-cells infused), given the narrow dose range, and the observed transgene level. Based on covariate search and subgroup analysis of maximum systemic CAR transgene level (Cmax ) and area under curve from the first dose to day 28 (AUC0-28d ), none of the investigated subjects' demographics, baseline characteristics, and manufactured product characteristics had significant effects on cilta-cel PK. The developed model is deemed robust and adequate for enabling subsequent exposure-safety and exposure-efficacy analyses. |
| Author | Jackson, Carolyn C. Zhou, Honghui Sun, Yu‐Nien Su, Yaming Li, Claire Wu, Liviawati S. Zhou, Wangda |
| AuthorAffiliation | 1 Janssen Research & Development Brisbane California USA 2 Janssen Research and Development Raritan New Jersey USA 4 Cognigen Division Simulations Plus Buffalo New York USA 5 Elevar Therapeutics Salt Lake City Utah USA 3 Janssen Research and Development Spring House Pennsylvania USA |
| AuthorAffiliation_xml | – name: 1 Janssen Research & Development Brisbane California USA – name: 2 Janssen Research and Development Raritan New Jersey USA – name: 4 Cognigen Division Simulations Plus Buffalo New York USA – name: 5 Elevar Therapeutics Salt Lake City Utah USA – name: 3 Janssen Research and Development Spring House Pennsylvania USA |
| Author_xml | – sequence: 1 givenname: Liviawati S. surname: Wu fullname: Wu, Liviawati S. email: lwu79@its.jnj.com organization: Janssen Research & Development – sequence: 2 givenname: Yaming surname: Su fullname: Su, Yaming organization: Janssen Research and Development – sequence: 3 givenname: Claire surname: Li fullname: Li, Claire organization: Janssen Research and Development – sequence: 4 givenname: Wangda surname: Zhou fullname: Zhou, Wangda organization: Janssen Research and Development – sequence: 5 givenname: Carolyn C. surname: Jackson fullname: Jackson, Carolyn C. organization: Janssen Research and Development – sequence: 6 givenname: Yu‐Nien surname: Sun fullname: Sun, Yu‐Nien organization: Simulations Plus – sequence: 7 givenname: Honghui surname: Zhou fullname: Zhou, Honghui organization: Elevar Therapeutics |
| BackLink | https://www.ncbi.nlm.nih.gov/pubmed/36204820$$D View this record in MEDLINE/PubMed |
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| CitedBy_id | crossref_primary_10_1002_psp4_13011 crossref_primary_10_1007_s40262_024_01413_z crossref_primary_10_1016_j_dmpk_2024_101003 crossref_primary_10_1002_cpt_2986 crossref_primary_10_1002_jcph_2346 crossref_primary_10_1158_1078_0432_CCR_24_2753 crossref_primary_10_1001_jamaoncol_2024_4879 |
| Cites_doi | 10.1002/j.1552-4604.1997.tb04326.x 10.1158/1078-0432.CCR-12-2422 10.1002/psp4.12388 10.1128/JVI.75.22.10663-10669.2001 10.1208/s12248-009-9112-5 10.1208/s12248-009-9133-0 10.1016/S0140-6736(21)00933-8 10.1172/JCI18025 10.1016/j.jtbi.2012.12.025 10.1007/s10928-008-9094-4 10.1007/s40262-021-01039-5 10.1007/s10928-007-9066-0 10.1023/A:1012299115260 10.1158/1078-0432.CCR-13-0168 |
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| Snippet | The aims of this work were to develop a population pharmacokinetic (PK) model for chimeric antigen receptor (CAR) transgene after single intravenous infusion... Abstract The aims of this work were to develop a population pharmacokinetic (PK) model for chimeric antigen receptor (CAR) transgene after single intravenous... |
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| SubjectTerms | Adult Antigens Body weight Chimeric antigen receptors Humans Immunotherapy, Adoptive - adverse effects Intravenous administration Kinetics Lymphocytes T Mathematical models Multiple myeloma Multiple Myeloma - drug therapy Normal distribution Pharmacokinetics Population Receptors, Chimeric Antigen - genetics T-Lymphocytes |
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| Title | Population‐based cellular kinetic characterization of ciltacabtagene autoleucel in subjects with relapsed or refractory multiple myeloma |
| URI | https://onlinelibrary.wiley.com/doi/abs/10.1111%2Fcts.13421 https://www.ncbi.nlm.nih.gov/pubmed/36204820 https://www.proquest.com/docview/2753736603 https://www.proquest.com/docview/2723159571 https://pubmed.ncbi.nlm.nih.gov/PMC9747118 https://doaj.org/article/6abaa7e8bea8476ab19122439fb83e1e |
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