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 at the 2025 National Immune Cell Effector Therapy (ICE-T) Conference, Tiba Al Sagheer, PharmD, BCOP, BCACP; Rebecca Gonzalez, PharmD, BCOP, FASTCT; and Syeda Saba Kareem PharmD, BCOP, spoke about their presentations on managing adverse effects (AEs) across different hematologic malignancy populations. At the meeting, Al Sagheer, Gonzalez, and Kareem presented their ideas for treating patients with lymphoma, leukemia, and multiple myeloma, respectively.

Al Sagheer is a Pharmacy Quality Improvement Coordinator and Transplant/Cellular Therapy and Hematology Clinical Pharmacy Specialist at Miami Cancer Institute of Baptist Health South Florida. Gonzalez is a clinical pharmacy specialist in Blood and Marrow Transplantation and Cellular Immunotherapy at Moffitt Cancer Center. Kareem is a clinical pharmacy supervisor in Malignant Hematology at Moffitt Cancer Center.

Across different disease states, the presenters outlined the most common toxicities associated with CAR T-cell therapy, bispecific antibodies, and other novel immunotherapies. Additionally, they described strategies for reducing the severity of AEs such as cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome as well as other oral, dermatological, and nail toxicities. Other key considerations for preserving quality of life among those receiving cellular therapy included risk stratifying patients based on tumor burden and inflammatory markers at baseline to inform prophylactic measures.

Each presenter shared key takeaways for treating patients who experience treatment-related AEs based on their individual presentations. Al Sagheer emphasized that it is not “one size fits all” when it comes to therapy, as providers must tailor their use of specific drugs, prophylactic measures, and anti-infective medication to each individual patient. Kareem noted that cellular therapy represents an evolving field, as toxicity mitigation strategies will continue to change over time as new data emerge. Finally, Gonzalez underscored the intimate nature of the cellular therapy field, which presents opportunities to collaborate with other institutions and receive guidance on managing complex cases.

Al Sagheer T. Mastering the management of adverse effects from cellular therapies in lymphoma. Presented at the 2025 National Immune Cell Effector Therapy (ICE-T) Conference; July 26, 2025; Orlando, FL.

Gonzalez R. Navigating the challenges: managing adverse effects of cellular therapies in ALL. Presented at the 2025 National Immune Cell Effector Therapy (ICE-T) Conference; July 26, 2025; Orlando, FL.

Kareem SS. Management of adverse events of CAR-T and T-cell engagers in myeloma. Presented at the 2025 National Immune Cell Effector Therapy (ICE-T) Conference; July 26, 2025; Orlando, FL.

A panel of clinical pharmacists discussed strategies for mitigating toxicities across different multiple myeloma, lymphoma, and leukemia populations.

Navigating AE Management for Cellular Therapy Across Hematologic Cancers

, in collaboration with the American Society for Transplantation and Cellular Therapy, organized an X Space hosted by Rahul Banerjee, MD, FACP; Taha Al-Juhaishi, MD; and Muhammad Salman Faisal, MD. This expert panel convened to discuss key presentations and abstracts of interest at the 

2025 American Society of Clinical Oncology (ASCO) Annual Meeting

, featuring noteworthy developments in modalities such as chimeric antigen receptor (CAR) T-cell therapy and transplantation across multiple myeloma, lymphoma, and other disease types.

Banerjee is an assistant professor in the Clinical Research Division at the Fred Hutchinson Cancer Center in Seattle, Washington. Al-Juhaishi is the associate director of the Hematopoietic Stem Cell Transplantation and Cell Therapy Program at Oklahoma University Health Stephenson Cancer Center and an assistant professor of medicine at the University of Oklahoma College of Medicine. Faisal is a hematologist/oncologist at Oklahoma University Health Stephenson Cancer Center and serves as an ambassador for ASCO.

The group highlighted several late-breaking abstracts, plenary sessions, and poster presentations focused on significant clinical trial data and other findings across the hematologic oncology landscape. Topics of interest included the following:

Phase 1b/2 CARTITUDE-1 trial (NCT03548207, NCT05201781)

Long-term follow-up showed that approximately one-third (33%; n = 32) of patients with relapsed/refractory multiple myeloma maintained progression-free status for at least 5 years following a single infusion of ciltacabtagene autoleucel (cilta-cel; Carvykti).

An equal likelihood of progression-free survival occurred in patients with high-risk cytogenetics or extramedullary plasmacytomas.

With a median follow-up of 61.3 months, the median overall survival (OS) with cilta-cel was 60.7 months (95% CI, 41.9-not evaluable [NE]).

Real-world axicabtagene ciloleucel (axi-cel; Yescarta) use

Across inpatient and outpatient treatment settings, safety and efficacy outcomes were comparable for patients who received axi-cel for relapsed/refractory large B-cell lymphoma.

Multivariate analysis showed no associations between intended care setting and cytokine release syndrome or immune effector cell–associated neurotoxicity syndrome.

Investigators noted that these real-world data support the consideration of axi-cel in appropriate outpatient settings.

Phase 1b/2 NEXICART-2 trial (NCT06097832)

Investigators assessed NXC-201, a sterically optimized CAR T construct, as a treatment for patients with relapsed/refractory light chain amyloidosis, a population with no FDA-approved options.

Among 12 patients who received the agent at 450 x 10

 cells, 100% achieved rapid and deep hematologic responses at a median time to first and best response of 7 and 26 days, respectively.

With a median follow-up of 121 days (range, 29-289), no hematologic relapses or progression had occurred.

Voorhees P, Martin T, Lin Y, et al. Long-term (≥5 year) remission and survival after treatment with ciltacabtagene autoleucel (cilta-cel) in CARTITUDE-1 patients (pts) with relapsed/refractory multiple myeloma (RRMM). 

2025;43(suppl 16):7507. doi:10.1200/JCO.2025.43.16_suppl.7507

Furqan F, Hemmer M, Tees M, et al. Trends and outcomes by inpatient and outpatient infusion of axicabtagene ciloleucel (axi-cel) in the US for patients (pts) with relapsed/refractory large B-cell lymphoma (R/R LBCL). 

2025;43(suppl 16):7023. doi:10.1200/JCO.2025.43.16_suppl.7023

Landau H, Hughes C, Rosenberg A, et al. Safety and efficacy data from NEXICART-2, the first US trial of CAR-T in R/R light chain (AL) amyloidosis, NXC-201. 

2025;43(suppl 16):7508. doi:10.1200/JCO.2025.43.16_suppl.7508

ASCO Annual Meeting: Hematology

An expert panel highlights key presentations in multiple myeloma, lymphoma, and other hematologic malignancies at the 2025 ASCO Annual Meeting.

CAR T and Transplantation Advances Across Hematologic Cancers at ASCO 2025

 and the American Society for Transplantation and Cellular Therapy (ASTCT) program 

Nora M. Gibson, MD, MSCE, and Taha Al-Juhaishi, MD, spoke about real-world applications of betibeglogene autotemcel (beti-cel; Zynteglo) as a treatment for patients with β-thalassemia. They spoke in the context of a study that Gibson presented at the 

 which evaluated patients who received commercial beti-cel in a single-center cohort following 

Gibson is a fourth-year fellow in bone marrow transplant and cellular therapy at the Children's Hospital of Philadelphia (CHOP), with a background in clinical research and epidemiology. Al-Juhaishi is the associate director of the Hematopoietic Stem Cell Transplantation and Cell Therapy Program at Oklahoma University Health Stephenson Cancer Center and an assistant professor of medicine at the University of Oklahoma College of Medicine.

Findings from Gibson’s study revealed that among 10 patients who underwent stem cell collection at CHOP from 2022 to 2024, beti-cel yielded consistent red blood cell transfusion independence, with investigators noting prolonged platelet engraftment time and high platelet transfusion requirements. Beyond these findings, the conversation focused on how beti-cel compares with other currently available gene therapies for patients with hemoglobin disorders as well as noncurative therapies such as allogeneic stem cell transplantation. Gibson and Al-Juhaishi also discussed strategies for mitigating occlusive disease and other potential toxicities associated with beti-cel.

“It's a really exciting time to be working in this field, where we finally have really good options for these patients. From our experience and from clinical trials, beti-cel and likely exagamglogene autotemcel [Casgevy]...are very effective, curative therapies for thalassemia in the real-world setting, and we've seen very similar results in sickle cell disease,” Gibson said. “These therapies have been life-changing for our patients, and they've had a huge reduction in their symptoms and a huge reduction in their burden of health care that's required.”

Gibson NM, Friedman DF, Elgarten CW, et al. Post-approval, real-world experience with betibeglogene autotemcel for transfusion-dependent beta thalassemia. 

 2025;31(2):S254. doi:10.1016/j.jtct.2025.01.386

FDA approves first cell-based gene therapy to treat adult and pediatric patients with beta-thalassemia who require regular blood transfusions. News release. FDA. August 17, 2022. Accessed April 21, 2025. https://tinyurl.com/3vrkk8kz

Therapies such as betibeglogene autotemcel have been “life-changing” for patients with β-thalassemia, according to Nora M. Gibson, MD, MSCE.

Reviewing Real-World Use of Beti-Cel in Transfusion-Dependent β-Thalassemia

In a special co-branded episode between Oncology On the Go hosted by CancerNetwork

and the American Society for Transplantation and Cellular Therapy (ASTCT)’s program 

Alexis K. Kuhn, PharmD, BCOP, spoke with Katie Bruce, PharmD, BCPPS, and Susie Long, PharmD, about the use of approved cell-based gene therapies for patients with sickle cell disease, beta thalassemia, adrenoleukodystrophy (ALD), and metachromatic leukodystrophy (MLD). These panelists shared the pharmacist’s perspective on ensuring quality care with these 

 gene therapies across all treatment phases, including mobilization, conditioning, and infection prophylaxis.

Kuhn is an ambulatory Pediatric Hematology/Oncology/BMT Pharmacist at the Mayo Clinic in Rochester, Minnesota, and an assistant professor of Pharmacy at the Mayo Clinic College of Medicine. Bruce is a pediatric clinical pharmacy specialist at the Sarah Cannon Pediatric Hematology/Oncology & Cellular Therapy program of Tristar Centennial Medical Center in Nashville, Tennessee. Long is a pediatric clinical pharmacist in the Blood and Marrow Team at the University of Minnesota Masonic Children's Hospital.

Specifically, the panelists spoke about the use of agents like elivaldogene autotemcel (Skysona) and atidarsagene autotemcel (Lenmeldy), which are FDA-approved for ALD and MLD, respectively.

 They also discussed the use of exagamglogene autotemcel (Casgevy) and lovotibeglogene autotemcel (Lyfgenia), which the FDA approved for treating patients 12 years and older with sickle cell disease in December 2023.

 The conversation broke down each stage of treatment, detailing optimal strategies for the cell manufacturing and storing processes as well as the management of toxicities like cytopenias. They also reviewed key considerations during the post-infusion period that may help maximize the quality of life for patients after they complete their therapy.

“It has been so amazing to be able to be a part of gene therapy and gene editing,” Bruce stated regarding the potential long-term impacts of these treatments. “We have patients who are able to hold full-time jobs they never were able to have before. We have patients who are climbing mountains and backpacking through Europe, which would have never been an option before because their sickle cell disease would have prevented them from [doing] that…. It’s not an easy process, and it has a lot of steps for the patient to go through, but the reward at the end of it all is worth it.”

bluebird bio receives FDA accelerated approval for SKYSONA® gene therapy for early, active cerebral adrenoleukodystrophy (CALD). News release. bluebird bio, Inc. September 16, 2022. Accessed October 7, 2024.https://tinyurl.com/mp8crxes

FDA approves first gene therapy for children with metachomatic leukodystrophy. New release. FDA. March 18, 2024. Accessed October 7, 2024. https://tinyurl.com/mrh659yk

FDA approves first gene therapies to treat patients with sickle cell disease. News release. FDA. December 8, 2023. Accessed October 7, 2024. https://tinyurl.com/3zbdnf4c

Contemporary Concepts in Hematologic Oncology

A panel of expert pharmacists provides their perspectives on gene therapy agents such as exagamglogene autotemcel in the management of sickle cell disease.

Leveraging Ex Vivo Gene Therapy Advancements in Hemoglobinopathies and Metabolic Diseases

 and the American Society for Transplantation and Cellular Therapy (ASTCT)’s program 

, Rahul Banerjee, MD, FACP, and Noopur Raje, MD, discussed the risk of secondary malignancies in patients with multiple myeloma who receive CAR T-cell therapy.

Banerjee is an assistant professor in the Clinical Research Division of Fred Hutchinson Cancer Center and an assistant professor in the Division of Hematology and Oncology at the University of Washington. Raje is the director of the Center for Multiple Myeloma at Massachusetts General Hospital Cancer Center and a professor of medicine at Harvard Medical School.

Banerjee and Raje spoke in the context of prior advisories from the FDA on the potential development of secondary T-cell malignancies in patients who receive CAR T-cell therapy for hematologic cancers. Specifically, the agency required a 

boxed warning for secondary T-cell malignancy risks

for BCMA- or CD19-targeting therapies in April 2024.

 The conversation also touched upon reports of secondary malignancies in cases and trials such as CARTITUDE-1 (NCT04181827), in which second primary cancers were highlighted in 9 patients who received treatment with ciltacabtagene autoleucel (Carvykti).

Considering these reports and warnings, Banerjee and Raje emphasized shared treatment decision-making with patients after assessing the risks and benefits of CAR T-cell therapy compared with other agents like bispecific antibodies. They also reviewed optimal strategies for monitoring and referring patients based on the incidence of certain toxicities.

“[Treatment with] CAR T cells requires planning, and we need to have good control of the disease. We need to have 4 to 6 weeks of a lead time to get these effective treatments to our patients, so early referral is a good idea,” Raje said. “[For example], if you see chronic diarrhea in someone that is way out of the window of what you would expect, referring back to the CAR T-cell center is important so that we don’t miss some of these toxicities.”

FDA requires boxed warning for T cell malignancies following treatment with BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies. News release. FDA. April 18, 2024. Accessed August 22, 2024. https://tinyurl.com/5n8pm5ca

San-Miguel J, Dhakal B, Yong K, et al. Cilta-cel or standard care in lenalidomide-refractory multiple myeloma. 

2023;389(4):335-347. doi:10.1056/NEJMoa2303379

American Society for Transplantation and Cellular Therapy

Experts in multiple myeloma weigh the benefits and risks of administering CAR T-cell therapy to patients based on prior reports of secondary malignancies.

Managing Secondary Cancer Risks After CAR T-Cell Therapy in Multiple Myeloma Subgroups

, Nausheen Ahmed, MD, spoke about optimizing monitoring strategies for patients with B-cell non-Hodgkin lymphoma who undergo treatment with CAR T-cell therapy.

Ahmed, an associate professor in the Division of Hematologic Malignancies and Cellular Therapeutics at the University of Kansas Medical Center, discussed the possibility of offering more flexible monitoring periods for patients in the context of findings from a 

 Data from her study showed that the occurrence of new onset cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) was rare at more than 2 weeks following CAR T-cell therapy infusion. Additionally, late non-relapse mortality generally resulted from infectious complications.

The FDA implemented a Risk Evaluation and Mitigation Strategy (REMS) to help manage the risk of severe CRS and ICANS by requiring patients to reside within 2 hours of an authorized treatment center for 4 weeks following CAR T-cell therapy infusion.

 According to the study authors, this mitigation strategy may create significant barriers to CAR T-cell therapy access among certain patients and caregivers who need to relocate as part of a treatment plan.

Findings from Ahmed’s study supported the development of individualized monitoring strategies depending on the stability of the patient. She and her coauthors proposed a 2-week monitoring period for patients while allowing for an optional increase to 4 weeks based on factors such as physician comfort and availability of local community oncology support. As Ahmed emphasized during the discussion, having flexibility in these monitoring periods could help mitigate financial and geographic obstacles preventing adequate access to CAR T-cell therapy among patients.

“There has to be more of a hybrid model of care. There has to be more involvement of our referring doctors or community doctors in detecting and managing these infections or working with the specialized center in order to bypass the [emergency room] and other strategies to help these patients,” Ahmed said. “If there is enough data to say that the patients do not need extra restrictions beyond 2 weeks, which is what our studies show, then reconsidering the requirements will be one step towards decreasing disparities in access.”

Ahmed N, Wesson W, Lutfi F, et al. Optimizing the post-CAR T monitoring period in recipients of axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel. 

 Published online July 24, 2024. doi:10.1182/bloodadvances.2023012549

Risk Evaluation and Mitigation Strategies (REMS) for autologous chimeric antigen receptor (CAR) T cell immunotherapies modified to minimize burden on healthcare delivery system. FDA. June 26, 2024. Accessed July 23, 2024. https://tinyurl.com/2m284rjy

Nausheen Ahmed, MD, discusses findings from a study supporting reduced monitoring windows for patients with lymphoma who receive CAR T-cell therapy.

Improving CAR T-Cell Therapy Monitoring Strategies and Access in Lymphoma

2024 European Hematology Association (EHA) Congress

 spoke with a variety of experts in the hematologic oncology space about optimizing outcomes across different patient populations and subgroups based on updated research they presented at the meeting.

Manali Kamdar, MD, an associate professor of medicine-hematology and clinical director of Lymphoma Services at the University of Colorado Anschutz Medical Campus, in Colorado, spoke about data from 

the phase 1 TRANSCEND NHL 001 trial (NCT02631044)

 supporting the use of lisocabtagene maraleucel (liso-cel; Breyanzi) in earlier lines of therapy for patients with relapsed/refractory mantle cell lymphoma (MCL).

Specifically, Kamdar highlighted how research should continue to focus on the potential utility of liso-cel in MCL subgroups such as those with 

mutations or blastoid morphology. Additionally, she stated that liso-cel may need to be further tested in earlier lines of therapy for patients with diffuse large B-cell lymphoma, including those with double-hit lymphoma.

Michael R. Grunwald, MD, chief of the Leukemia Division and director of the Transplantation and Cellular Therapy Program at Atrium Health’s Levine Cancer Institute, in North Carolina, discussed findings from the Prospective Observational Study of Patients With Polycythemia Vera (PV) in US Clinical Practices Trial (REVEAL) exploring risk factors for disease progression in patients with polycythemia vera (PV).

According to Grunwald, a history of thromboembolic events, elevated white blood cell counts, and higher variant allele frequencies may contribute to a patient’s likelihood of experiencing progression to myelofibrosis or acute myeloid leukemia (AML). Additionally, he highlighted ongoing research into the potential molecular factors that may prognosticate disease transformation in PV among a small cohort of patients enrolled on the REVEAL trial.

Harry P. Erba, MD, PhD, a professor of medicine in the Division of Hematologic Malignancies and Cellular Therapy and the director of the Leukemia Program and Phase I Development in Hematologic Malignancies at Duke Cancer Institute, in North Carolina, discussed the clinical implications of data from the phase 3 QuANTUM-First study (NCT02668653).

Specifically, findings demonstrated that continuation therapy with quizartinib (Vanflyta) elicited a more pronounced survival benefit vs placebo in patients with newly diagnosed 

-ITD–positive AML who did not undergo allogeneic hematopoietic stem cell transplant (allo-HSCT). However, Erba noted that survival outcomes were not significantly different in the quizartinib and placebo arms among patients who received allo-HSCT.

Experts discuss updated findings presented at the 2024 EHA Congress in diseases such as mantle cell lymphoma and acute myeloid leukemia.

Hematologic Oncology

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