Cytopenias and infections following ciltacabtagene autoleucel in heavily pretreated relapsed or refractory multiple myeloma

Sep 30, 2026

Ciltacabtagene autoleucel (cilta-cel) was evaluated in a multicenter retrospective standard-of-care setting to characterize cytopenias and infections after infusion in heavily pretreated relapsed/refractory multiple myeloma. Among 105 treated patients, grade ≥3 cytopenia occurred in 52% on day 30 and 24% on day 90. Using ICAHT neutropenia grading, 10% had grade ≥3 early events within 30 days versus 3.3% late after day 30. Infections developed in 49% and were severe in 32%, with earlier infections split bacterial/viral (42% each) and later mostly viral.

LanguageEnglish

CategoryHealthcare

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Abstract

Introduction

ARTICLE-Cell Therapy & Immunotherapy Cytopenias and infections following ciltacabtagene autoleucel in heavily pretreated relapsed or refractory multiple myeloma Danai Dima,1* Jennifer M. Logue,2* Syed Hamza Bin Waqar,2* Lauren C. Peres,2 Christelle M. Colin-Leitzinger,2 Gabriel De Avila,2 Eric C. Smith,2 Lawrence Skelson,2 Kristy L. Matte,2 Brandon Blue,2 Vanna N. Hovanky,3 Mahmoud Gaballa,4 Oren Pasvolsky,4 Laura B. Oswald,2 Gliceida M. Galarza Fortuna,5 Charlotte B. Wagner,5 Shaun DeJarnette,6 Christen Dillard,4 Fabiana Perna,2 Lekha Mikkilineni,3 Hitomi Hosoya,3 Ciara L. Freeman,2 Kenneth H. Shain,2 Rachid C. Baz,2 Ariel Grajales-Cruz,2 Omar Castaneda Puglianini,2 Melissa Alsina,2 Frederick L. Locke,2 Leyla O. Shune,6 Douglas W. Sborov,5 Krina K. Patel,4\# Surbhi Sidana,3\# and Doris K. Hansen2\# 1 University of Washington, Fred Hutch Cancer Center, Seattle, WA; 2 H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL; 3Stanford University School of Medicine, Stanford, CA; 4 MD Anderson Cancer Center, Houston, TX; 5 University of Utah School of Medicine, Salt Lake City, UT and 6 University of Kansas Medical Center, Kansas City, KS, USA *DD, JML and SHBW contributed equally as first authors. \#KKP, SS and DKH contributed equally as senior authors. Abstract Correspondence: D. K. Hansen [Doris. Hansen@moffitt.org](Doris. Hansen@moffitt.org) S. Sidana [surbhi.sidana@stanford.edu](surbhi.sidana@stanford.edu) [Received:](Received: March 12)[ March 12](Received: March 12), 2025. Accepted: June 30, 2025. Early view: July 10, 2025. [https://doi.org/10.3324/haematol.2025.287783](https://doi.org/10.3324/haematol.2025.287783) ©2026 Ferrata Storti Foundation Published under a CC BY-NC license Ciltacabtagene autoleucel (cilta-cel) was approved by the Food and Drug Administration in February 2022 for the treatment of relapsed/refractory multiple myeloma after four lines of therapy. On the CARTITUDE-1 trial, grade ≥3 cytopenias and infections were common. Herein, we sought to characterize cytopenias and infections after cilta-cel infusion in the standardof-care setting. This multicenter, retrospective study included 105 patients who received cilta-cel; 91 reached day 90 and 49 reached day 180 of follow-up. Grade ≥3 cytopenia was present among 52% of patients on day 30, and 24% of patients on day 90. Based on the newer immune effector cell-associated hematotoxicity (ICAHT) grading for neutropenia severity, 11 patients (10%) experienced grade ≥3 early ICAHT in the first 30 days, while only three (3.3%) experienced grade ≥3 late ICAHT after day 30. On univariate analysis, any grade thrombocytopenia at apheresis was associated with grade ≥3 cytopenia at both days 30 and 90. Granulocyte colony-stimulating factor was administered to 65%, transfusion support to 38%, thrombopoietin agonists to 10%, intravenous immunoglobulins to 52%, and CD34+ stem cell boosts to 9.5% of patients. Infections occurred in 49% of patients and were severe in 32% . Earlier infections in the first 30 days were equally bacterial (42%) and viral (42%) . Later infections between days 31-100 and after day 100 were mostly viral (59% and 60%, respectively), with only 32% and 12% being grade ≥3 in each time period. On univariate analysis, worse Eastern Cooperative Oncology Group performance status at lymphodepletion, higher maximum grade of cytokine-release syndrome, delayed neurotoxicity, steroid and anakinra use, and lower IgA levels at day 90 were associated with severe infections. Introduction Multiple myeloma is an incurable plasma cell neoplasm despite recent advancements in therapeutic modalities. The proclivity for relapse and refractoriness to conventional plasma cell-directed treatments, including proteasome inhibitors, immunomodulatory agents, and anti-CD38 antibodies, underscores the challenging clinical landscape marked by inferior outcomes 1-4 Ciltacabtagene autoleucel (cilta-cel) is a second-generation autologous

FAQs

What is cilta-cel and what patient setting does the study address?

Ciltacabtagene autoleucel (cilta-cel) is a BCMA-targeting CAR T-cell therapy. The study examines its toxicities in a standard-of-care, heavily pretreated relapsed or refractory multiple myeloma population after multiple prior lines of therapy.

How common were grade ≥3 cytopenias after cilta-cel infusion?

Grade ≥3 cytopenia appeared in 52% of patients on day 30 and 24% on day 90. For early vs late neutropenia severity using ICAHT, 10% experienced grade ≥3 within the first 30 days compared with 3.3% after day 30.

What were the main infection patterns and severity findings?

Infections occurred in 49% of patients and were severe in 32%. Early infections in the first 30 days were evenly split between bacterial and viral causes (42% each), while infections from day 31–100 and after day 100 were mostly viral (59% and 60%).

Sep 30, 2026

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