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Obecabtagene autoleucel (autologous)

Class
CAR T cell therapy
Subclass
CD19-directed genetically modified autologous T cells
Substance name
Obecabtagene autoleucel, obe-cel
Brand names
Aucatzyl®
Common formulations
Suspension
Indications for use
Labeled indications
Adults
•
Treatment of precursor B-cell lymphoblastic leukemia (relapsed or refractory, bone marrow blasts >20% or inconclusive)
•
Treatment of precursor B-cell lymphoblastic leukemia (relapsed or refractory, bone marrow blasts ≤20%)
Safety risks
Boxed warnings
Cytokine release syndrome
•
Maintain a high level of suspicion, as obecabtagene autoleucel has been associated with an increased risk of cytokine release syndrome. Premedicate with acetaminophen 30 minutes before infusion to minimize infusion reactions, and avoid corticosteroids as they may interfere with drug activity. Monitor patients daily for cytokine release syndrome at a healthcare facility for 14 days and periodically for 4 weeks post-infusion. Instruct patients to stay within proximity of a healthcare facility for at least 4 weeks following the first infusion. Delay infusion until CRS resolves to Grade ≤1 for Grade 2 reactions; discontinue treatment for Grade ≥3 reactions.
Immune effector cell-associated neurotoxicity syndrome
•
Maintain a high level of suspicion, as obecabtagene autoleucel has been associated with an increased risk of immune effector cell-associated neurotoxicity syndrome, which were fatal and life-threatening reactions. Monitor patients daily for mmune effector cell-associated neurotoxicity syndrome at a healthcare facility for 14 days and periodically for 4 weeks post-infusion. Instruct patients to remain within proximity of a healthcare facility for at least 4 weeks following the first infusion and to refrain from driving or engaging in hazardous activities for at least 8 weeks post-infusion. Postpone infusion until day 21 to allow immune effector cell-associated neurotoxicity syndrome to fully resolve in Grade 1 reactions. Discontinue treatment for Grade ≥2 reactions.
T-cell malignancies
•
Maintain a high level of suspicion, as BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies are associated with an increased risk of T-cell malignancies.
Contraindications
Active infection or inflammatory disorders
Use of live vaccines
•
Do not use live vaccines for at least 6 weeks before lymphodepleting chemotherapy, throughout obecabtagene autoleucel treatment, and until immune recovery is achieved following treatment.
Warnings and precautions
Cytopenias
•
Maintain a high level of suspicion, as lymphodepleting chemotherapy and obecabtagene autoleucel can cause cytopenias, including anemia, neutropenia, and thrombocytopenia, which may persist for several weeks post-treatment. Monitor blood counts after each infusion.
Hemophagocytic lymphohistiocytosis, macrophage activation syndrome
•
Maintain a high level of suspicion, as obecabtagene autoleucel has been associated with an increased risk of hemophagocytic lymphohistiocytosis/macrophage activation syndrome, including life-threatening and fatal reactions.
Hypersensitivity reactions
•
Maintain a high level of suspicion, as serious hypersensitivity reactions, including anaphylaxis, may occur due to dimethyl sulfoxide in the obecabtagene autoleucel preparation. Monitor patients for hypersensitivity reactions during and after infusion.
Hypogammaglobulinemia
•
Maintain a high level of suspicion, as obecabtagene autoleucel may cause hypogammaglobulinemia and B-cell aplasia. Monitor serum immunoglobulin levels following each infusion.
Infections
•
Maintain a high level of suspicion, as obecabtagene autoleucel has been associated with an increased risk of severe, including life-threatening and fatal infections. Screen for HBV, HCV, and HIV infections per clinical guidelines before cell collection for manufacturing. Monitor patients for signs and symptoms of infection before and after obecabtagene autoleucel infusion. Administer prophylactic antimicrobials according to local guidelines. Postpone infusion until day 21 for Grade ≥3 adverse reactions, ensuring severe intercurrent infections are controlled before proceeding.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
•
No guidance available.
Renal replacement therapy
Any modality
•
No guidance available.
Hepatic impairment
Any severity
•
No guidance available.
Pregnancy and breastfeeding
Pregnancy
All trimesters
•
Do not use. Obecabtagene autoleucel may cause fetal toxicity, including B-cell lymphocytopenia and hypogammaglobulinemia, if transduced cells cross the placenta. Ensure females of reproductive potential have a negative pregnancy test before treatment.
Breastfeeding
Use only if benefits outweigh potential risks.
Unknown amount excreted in breastmilk.
Unknown drug levels in breastfed infants.
Adverse reactions
Very common > 10%
•
Anemia, bacterial infections, cytokine release syndrome, ↓ WBC count, ↓ blood lymphocyte count, ↓ blood neutrophil count, ↓ platelet count, ↓ serum ferritin, encephalopathy, febrile neutropenia, fungal infections, immune effector cell-associated neurotoxicity syndrome, abdominal pain, bleeding, constipation, chills, weight loss, diarrhea, dizziness, cough, fatigue, headache, loss of appetite, musculoskeletal pain, nausea, fever, pain, hypotension, skin rash, vomiting, tachycardia, edema, viral infections
Common 1-10%
•
Adrenal insufficiency, macrophage activation syndrome, hemophagocytic lymphohistiocytosis, ascites, graft-versus-host disease, pleural effusion, cardiac arrhythmias, stomatitis, delirium, coagulopathy, hypogammaglobulinemia, heart failure, ↑ serum AST, motor impairment, renal dysfunction, palpitations, visual disturbances, infusion-related reactions, seizure, skin ulceration, respiratory failure, thrombosis, tremor
Unknown frequency
•
T-cell malignancies
Interactions
Drug(s)
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