Trial reportClinical pharmacokinetics2025
Population Cellular Kinetics of Idecabtagene Vicleucel in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma.
Trial report in Clinical pharmacokinetics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03651128 (A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma), which is not on this map. Cited by 5 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects With Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3)
Who cites it
5 citing papers in PubMed.
- Characterizing Cellular Expansion of Idecabtagene Vicleucel and Association with Clinical Efficacy and Safety in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma.Journal of clinical pharmacology · 2025Trial
- Population Cellular Kinetics of Idecabtagene Vicleucel in Patients with Triple-Class-Exposed Relapsed/Refractory Multiple Myeloma.Clinical pharmacokinetics · 2025Trial
- Patient-Specific Determinants of Response to BCMA- and GPRC5D-Targeted CAR T-Cell Therapy in Multiple Myeloma: A QSP Analysis of Clinical Trial and Real-World Data.Clinical pharmacology and therapeutics · 2026Article
- Model-Based Analysis with Mechanistic Insights to CAR-T-Cell Therapy Kinetics: Case Study with Axicabtagene Ciloleucel and Brexucabtagene Autoleucel.Clinical pharmacology and therapeutics · 2026Article
- Epitope mapping of humoral immunogenicity of orvacabtagene autoleucel shows an IgM response with minimal impact on CAR T cellular kinetics.Molecular therapy. Advances · 2026Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIdecabtagene vicleucel (ide-cel, ABECMA) is an autologous, B-cell maturation antigen (BCMA)-directed, chimeric antigen receptor (CAR) T-cell therapy. The current modeling analyses aim to characterize the cellular kinetics (CK) of ide-cel and to assess the covariate effects impacting ide-cel cellular kinetics in patients with relapsed/refractory multiple myeloma.
methodsA modified piecewise model was developed to characterize ide-cel CK through the nonlinear mixed effects method. The model parameterization was conducted using the ide-cel whole-blood transgene data in CK-evaluable subjects (N = 225) from the ide-cel arm of the study KarMMa-3 (NCT03651128). The structural model consists of an initial lag phase and then saturable cell expansion, followed by conversion from effector cells to memory cells and their elimination. Model simulations were performed to evaluate covariate effects on ide-cel exposure parameters.
resultsThe piecewise CK model with saturable expansion sufficiently captured the clinically observed ide-cel transgene data. The simulations using the final population CK model suggested that the magnitude of covariate effects on ide-cel exposure parameters was considerably smaller than the intersubject variability in the population. Additional analyses revealed a negative effect of treatment-emergent immunogenicity on the ide-cel persistence. Apparent associations were identified between cellular kinetic parameters and clinical responses.
conclusionsThe cellular kinetics of ide-cel can be adequately described by the modified piecewise model. No clinically meaningful covariate effects on cellular kinetics were identified from this modeling study. The population CK model suggests that higher cell expansion rate and lower elimination rates of effector and memory cells were observed in patients with longer progression-free survival.
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