TM Owner Autolus Inc
Aucatzyl 410 x 10^6 CD19 CAR-positive viable T cells Injection
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Indications & Clinical Uses
- Aucatzyl (obecabtagene autoleucel) is a CD19-directed genetically modified autologous CAR T-cell immunotherapy given as a suspension for intravenous infusion.
- It is approved for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia; the European conditional marketing authorisation, granted on 17 July 2025, restricts it to adults aged 26 years and over.
- Aucatzyl is made individually for each patient from that patient's own T cells, which are collected by leukapheresis, engineered in a laboratory to recognise the CD19 protein on leukaemia cells, and returned as a one-time treatment course.
- The total dose is 410 million CAR-positive viable T cells, split between an infusion on Day 1 and a second on Day 10, give or take 2 days, after lymphodepleting chemotherapy.
- It is for autologous use only and is given exclusively in a qualified cell-therapy centre with tocilizumab and emergency equipment immediately available.
Side Effects
- Aucatzyl carries a boxed warning covering cytokine release syndrome, which occurred in about 75 in 100 patients and can be severe or life-threatening; immune effector cell-associated neurotoxicity syndrome (ICANS), reported in about 64 in 100 patients, including fatal and life-threatening reactions; and the occurrence of T-cell malignancies after treatment with CD19-directed CAR T-cell therapies.
- Reactions affecting at least 1 in 5 patients include fever, chills, low blood pressure, bacterial and viral infections, febrile neutropenia, muscle and joint pain, nausea, diarrhoea, headache, confusion or encephalopathy, bleeding, pain and fatigue.
- Prolonged low blood counts lasting weeks are common, and low antibody levels occurred in about 1 in 10 patients.
- Fatal adverse reactions have occurred.
- Report immediately any fever, chills, dizziness, breathlessness, confusion, difficulty speaking or writing, tremor, seizure, severe headache, bruising or bleeding, however mild it seems at first.
Precautions & Warnings
- Aucatzyl is given only at a qualified treatment centre.
- Lymphodepleting chemotherapy with fludarabine 30 mg/m2 daily for 4 days and cyclophosphamide 500 mg/m2 daily for 2 days precedes the first infusion, and paracetamol is given about 30 minutes beforehand; systemic corticosteroids must not be used as premedication.
- You are monitored daily for at least 7 days after each infusion and for at least 2 weeks in total after each one, and you must stay near the treatment centre for that period.
- Do not drive, operate machinery or do anything that needs alertness for at least 2 weeks after each infusion.
- You must never donate blood, organs, tissues or cells afterwards.
- Lifelong follow-up for secondary malignancies is required, and long-term registry follow-up lasts about 15 years.
- Aucatzyl is not recommended in pregnancy.
- The product is shipped and stored frozen in the vapour phase of liquid nitrogen below minus 150°C.
Avoid Interactions
- Tell the transplant and haematology team about every medicine and supplement you use.
- Live vaccines should not be given during lymphodepleting chemotherapy, during Aucatzyl treatment, or until immune recovery after treatment.
- Avoid systemic corticosteroids as premedication, because they can interfere with the CAR T cells; steroids are still used as treatment if severe cytokine release syndrome or neurotoxicity develops.
- Tocilizumab must be available on site before infusion.
- Tell your team about any immunosuppressant, because these can blunt the response, and about drugs that suppress the bone marrow, which add to prolonged low blood counts.
- Because infections are common and antibody levels can fall, you may be given antimicrobial prophylaxis and immunoglobulin replacement, and these should not be stopped without advice.
- Aucatzyl may cause a false-positive result on some HIV tests based on PCR.
- Do not receive any other CAR T-cell product without specialist advice.
References
Frequently Asked Questions
Aucatzyl (obecabtagene autoleucel) is a CD19-directed CAR T-cell therapy for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia. It is made from your own T cells, re-engineered to attack leukaemia cells. The European authorisation limits it to adults aged 26 years and over.
Aucatzyl is given as an intravenous infusion at a qualified cell-therapy centre, never at home. The total dose of 410 million CAR-positive T cells is split into two infusions, on Day 1 and on Day 10 plus or minus 2 days, after lymphodepleting chemotherapy with fludarabine and cyclophosphamide.
Aucatzyl (obecabtagene autoleucel) carries a boxed warning for cytokine release syndrome, in about 75 in 100 patients, and neurologic toxicity or ICANS, in about 64 in 100, both potentially fatal. Common effects include fever, infections, low blood counts, low blood pressure, nausea, diarrhoea, headache and confusion.
Do not drive or operate machinery for at least 2 weeks after each Aucatzyl infusion, because neurologic toxicity can appear suddenly. Never donate blood, organs, tissues or cells afterwards. Avoid live vaccines until your immune system recovers, and avoid steroid premedication, which can interfere with the CAR T cells.
You are monitored daily for at least 7 days after each Aucatzyl infusion and for at least 2 weeks in total, and you must stay close to the treatment centre. Tocilizumab is kept on site for cytokine release syndrome. Report fever, chills, breathlessness, confusion or trouble speaking immediately.
Aucatzyl is a one-time treatment course, but follow-up is lifelong. Because T-cell malignancies have occurred after CD19-directed CAR T-cell therapies, you are monitored for secondary cancers for life, with long-term registry follow-up lasting about 15 years. Low blood counts and low antibody levels can persist for weeks or months.
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