Idecabtagene Vicleucel

ABECMA is a chimeric antigen receptor (CAR)-positive T cell therapy targeting B-cell maturation antigen (BCMA), which is expressed on the surface of normal and malignant plasma cells. The CAR construct includes an anti-BCMA scFv-targeting domain for antigen specificity, a transmembrane domain, a CD3-zeta T cell activation domain, and a 4-1BB costimulatory domain.

• ABECMA is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. ABECMA is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.ICD-10: C90.00

• None. None.contraindicated

For autologous use only. For intravenous use only. • Do NOT use a leukodepleting filter. ( 2.2 ) • Administer a lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine before infusion of ABECMA. ( 2.2 ) • Confirm the patient's identity prior to infusion. ( 2.2 ) • Premedicate with acetaminophen and an H 1 -antihistamine. ( 2.2 ) • Avoid prophylactic use of dexamethasone or other systemic corticosteroids. ( 2.2 ) • Confirm availability of tocilizumab prior to infusion. ( 2.2 , 5.2 ) • Dosing of ABECMA is based on the number of chimeric antigen receptor (CAR)-positive T cells. ( 2.1 ) • The recommended dose range is 300 to 510 × 10 6 CAR-positive T cells. ( 2.1 ) 2.1 Dose For autologous use only. For intravenous use only. ABECMA is provided as a single dose for infusion containing a suspension of chimeric antigen receptor (CAR)-positive T cells in one or more infusion bags. The recommended dose range is 300 to 510 × 10 6 CAR-positive T cells. See the accompanying Release for Infusion Certificate (RFI Certificate) for additional information pertaining to dose [see How Supplied/Storage and Handling (16) ] . 2.2 Administration ABECMA is for autologous use only. The patient's identity must match the patient identifiers on the ABECMA cassette(s) and infusion bag(s). Do not infuse ABECMA if the information on the patient-specific label(s) does not match the intended patient. Preparing Patient for ABECMA Infusion Confirm the availability of ABECMA prior to starting the lymphodepleting chemotherapy regimen.

• Hypersensitivity Reactions : Monitor for hypersensitivity reactions during infusion. ( 5.5 ) • Infections : Monitor patients for signs and symptoms of infection; treat appropriately. ( 5.6 ) • Prolonged Cytopenias : Patients may exhibit prolonged Grade 3 or higher cytopenias following ABECMA infusion. Monitor blood counts prior to and after ABECMA infusion. ( 5.7 ) • Hypogammaglobulinemia : Monitor and consider immunoglobulin replacement therapy. ( 5.8 ) • Secondary Malignancies : T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including ABECMA. In the event that a secondary malignancy occurs after treatment with ABECMA, contact Bristol-Myers Squibb at 1-888-805-4555. ( 5.9 ) 5.1 Early Death In Study 1, a randomized (2:1), controlled trial, a higher proportion of patients experienced death within nine months after randomization in the ABECMA arm (45/254; 18%) compared to the standard regimens arm (15/132; 11%) [see Clinical Studies (14) ] . Early deaths occurred in 8% (20/254) and 0% prior to ABECMA infusion and standard regimen administration, respectively, and 10% (25/254) and 11% (15/132) after ABECMA infusion and standard regimen administration, respectively. Out of the 20 deaths that occurred prior to ABECMA infusion, 15 occurred from disease progression, 3 occurred from adverse events and 2 occurred from unknown causes.

The following adverse reactions are described elsewhere in the labeling: • Early Death [see Warnings and Precautions (5.1) , Clinical Studies (14) ] • Cytokine Release Syndrome [see Warnings and Precautions (5.2) ] • Neurologic Toxicities [see Warnings and Precautions (5.3) ] • Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS) [see Warnings and Precautions (5.4) ] • Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] • Infections [see Warnings and Precautions (5.6) ] • Prolonged Cytopenias [see Warnings and Precautions (5.7) ] • Hypogammaglobulinemia [see Warnings and Precautions (5.8) ] The most common nonlaboratory adverse reactions (incidence ≥20%) include pyrexia, CRS, hypogammaglobulinemia, infections–pathogen unspecified, musculoskeletal pain, fatigue, febrile neutropenia, hypotension, tachycardia, diarrhea, nausea, headache, chills, upper respiratory tract infection, encephalopathy, edema, dyspnea and viral infections. ( 6.1 ) The most common Grade 3 or 4 laboratory adverse reactions (incidence ≥50%) include leukocyte count decreased, neutrophil count decreased, lymphocyte count decreased, platelet count decreased, and hemoglobin decreased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8.1 Pregnancy Risk Summary There are no available data with ABECMA use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with ABECMA to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if ABECMA has the potential to be transferred to the fetus. Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including plasma cell aplasia or hypogammaglobulinemia. Therefore, ABECMA is not recommended for women who are pregnant, and pregnancy after ABECMA infusion should be discussed with the treating physician. Assess immunoglobulin levels in newborns of mothers treated with ABECMA. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. The estimated background risk in the U.S. general population of major birth defects is 2% to 4% and of miscarriage is 15% to 20% of clinically recognized pregnancies. 8.2 Lactation Risk Summary There is no information regarding the presence of ABECMA in human milk, the effect on the breastfed infant, and the effects on milk production.

Metabolism

Following ABECMA infusion, the CAR-positive T cells proliferate and undergo rapid multi-log expansion followed by a bi-exponential decline. The median time of maximal expansion in peripheral blood (T max ) occurred 11 days after infusion.

1. 1Cytokine Release Syndrome66958%
2. 2Immune Effector Cell-associated Neurotoxicity Syndrome18916%
3. 3Fatigue16014%
4. 4Neutropenia837.2%
5. 5Anaemia776.6%
6. 6Neurotoxicity756.5%
7. 7Pyrexia726.2%
8. 8Hypogammaglobulinaemia605.2%
9. 9Nausea564.8%
10. 10Headache554.7%
11. 11Decreased Appetite544.7%
12. 12Death514.4%
13. 13Aspartate Aminotransferase Increased484.1%
14. 14Thrombocytopenia484.1%
15. 15Plasma Cell Myeloma474.1%

The 10 most recently updated of 32 ClinicalTrials.gov registrations naming Idecabtagene Vicleucel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Iberdomide Versus Observation Off Therapy After Idecabtagene Vicleucel CAR-T for Multiple Myeloma
  Suspended · Phase 2 · Interventional · 78 enrolled · National Cancer Institute (NCI)
  NCT06179888updated 2026-06-11
• A Phase 1 Study Evaluating DISP-10 in Participants With Advanced Gastrointestinal Cancers
  Recruiting · Phase 1 · Interventional · 66 enrolled · Dispatch Biotherapeutics
  NCT07544589updated 2026-05-29
• Upfront Chimeric Antigen Receptor T-Cell to Upgrade Response in Multiple Myeloma
  Completed · Phase 2 · Interventional · 40 enrolled · Medical College of Wisconsin
  NCT05032820updated 2026-05-19
• Nivolumab in Multiple Myeloma Patients After Idecabtagene Vicleucel
  Active not recruiting · Phase 2 · Interventional · 1 enrolled · Wake Forest University Health Sciences
  NCT06523621updated 2026-04-16
• Mezigdomide (CC-92480) Post Idecabtagene Vicleucel in Treating Patients With Relapsed Multiple Myeloma
  Recruiting · Phase 1 · Interventional · 15 enrolled · City of Hope Medical Center
  NCT06048250updated 2026-04-07
• A Study of Whether Ide-cel (bb2121) Can Be Made From People With Multiple Myeloma Who Have Had a Hematopoietic Cell Transplant
  Active not recruiting · Phase 2 · Interventional · 24 enrolled · Memorial Sloan Kettering Cancer Center
  NCT05393804updated 2026-04-02
• Anti BCMA CAR- T Cell Therapy for Adults With Relapsed or Refractory Multiple Myeloma
  Recruiting · Phase 1 · Phase 2 · Interventional · 30 enrolled · Minsk Scientific-Practical Center for Surgery, Transplantation and Hematology
  NCT07477912updated 2026-03-17
• Elranatamab in R/R Multiple Myeloma
  Recruiting · Phase 2 · Interventional · 32 enrolled · Massachusetts General Hospital
  NCT06138275updated 2026-03-13
• A Study to Compare the Efficacy and Safety of Idecabtagene Vicleucel With Lenalidomide Maintenance Therapy Versus Lenalidomide Maintenance Therapy Alone in Adult Participants With Newly Diagnosed Multiple Myeloma Who Have Suboptimal Response After Autologous Stem Cell Transplantation
  Active not recruiting · Phase 3 · Interventional · 79 enrolled · Celgene
  NCT06045806updated 2026-03-05
• An Efficacy and Safety Study of bb2121 in Subjects With Relapsed and Refractory Multiple Myeloma and in Subjects With High-Risk Multiple Myeloma
  Completed · Phase 2 · Interventional · 312 enrolled · Celgene
  NCT03601078updated 2026-03-04

Frequently asked questions

How does Idecabtagene Vicleucel work?

ABECMA is a chimeric antigen receptor (CAR)-positive T cell therapy targeting B-cell maturation antigen (BCMA), which is expressed on the surface of normal and malignant plasma cells. The CAR construct includes an anti-BCMA scFv-targeting domain for antigen specificity, a transmembrane domain, a CD3-zeta T cell activation domain, and a 4-1BB costimulatory domain.

What is Idecabtagene Vicleucel used for?

According to FDA labeling, Idecabtagene Vicleucel carries indications including: ABECMA is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody. ABECMA is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Idecabtagene Vicleucel?

Idecabtagene Vicleucel is classified as Antineoplastic cell and gene therapy, Antibody-Surface Antigen Interactions, Immunologic Activity Alteration.

What are the brand names for Idecabtagene Vicleucel?

Idecabtagene Vicleucel is marketed under brand names including Abecma.

What are the contraindications for Idecabtagene Vicleucel?

Idecabtagene Vicleucel labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.