Obecabtagene Autoleucel

AUCATZYL is a CD19-directed genetically modified autologous T cell immunotherapy consisting of the patient's own T cells expressing an anti-CD19 CAR. Engagement of anti-CD19 CAR-positive T cells with CD19 expressed on target cells, such as cancer cells and normal B cells, leads to activation of the anti-CD19 CAR-positive T cells and downstream signaling through the CD3-zeta domain.

• INDICATION AND USAGE AUCATZYL is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). AUCATZYL is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) ( 1 ).ICD-10: C95.90

• None. None ( 4 ).contraindicated

For autologous use only. For intravenous use only. Do NOT use a leukodepleting filter ( 2.4 ). Prior to infusion Administer a lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide. ( 2.3 ). Ensure availability of bone marrow assessment results from a sample obtained within 7 days prior to start of lymphodepleting chemotherapy ( 2.3 ). Premedicate with acetaminophen ( 2.3 ). Confirm availability of tocilizumab prior to infusion ( 2.3 ). AUCATZYL Dose and Administration Verify patient's identity prior to infusion ( 2.3 ). Dosing is based on the Dose Schedule Planner ( 2.3 ). The total recommended dose of AUCATZYL is 410 × 10 6 CD19 chimeric antigen receptor (CAR)-positive viable T cells ( 2.1 ). The treatment regimen consists of a split dose infusion to be administered on Day 1 and Day 10 (± 2 days) ( 2.1 ). Dose to be administered is determined by the patient bone marrow blast assessment. See Full Prescribing Information for important preparation and administration information ( 2.3 , 2.4 ). 2.1 Dose For autologous use only. For intravenous use only. Strictly follow Administration instructions to minimize dosing errors [see Overdosage (10) ] . The total recommended dose of AUCATZYL is 410 × 10 6 CD19 chimeric antigen receptor (CAR)-positive viable T cells supplied in three to five infusion bags. Bags are supplied in three color-coded bag configurations (10 × 10 6 , 100 × 10 6 , 300 × 10 6 ) for split dose administration.

Prolonged Cytopenias: Patients may exhibit Grade 3 or higher cytopenias for several weeks following AUCATZYL infusion. Monitor complete blood counts ( 5.3 ). Infections: Monitor patients for signs and symptoms of infection; treat appropriately ( 5.4 ). Hypogammaglobulinemia: Monitor and consider immunoglobulin replacement therapy ( 5.5 ). Hemophagocytic Lymphohistiocytosis/ Macrophage Activation Syndrome: Administer treatment per institutional standards ( 5.6 ). Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion ( 5.7 ). Secondary Malignancies: T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies. In the event that a secondary malignancy occurs after treatment with AUCATZYL, contact Autolus Inc at 1-855-288-5227 ( 5.8 ). 5.1 Cytokine Release Syndrome Cytokine Release Syndrome (CRS) occurred following treatment with AUCATZYL. CRS was reported in 75% (75/100) of patients including Grade 3 CRS in 3% of patients. The median time to onset of CRS was 8 days (range: 1 to 23 days) with a median duration of 5 days (range: 1 to 21 days). Sixty-eight percent of patients (51/75) experienced CRS after the first infusion, but prior to the second infusion of AUCATZYL with a median time to onset of 6 days (range: 1 to 10 days). Among patients with CRS, the most common manifestations of CRS included fever (100%), hypotension (35%) and hypoxia (19%) [see Adverse Reactions (6) ] .

The most common (non-laboratory) adverse reactions (incidence ≥ 20%) are: CRS, infections - pathogen unspecified, musculoskeletal pain, viral infections, fever, nausea, bacterial infectious disorders, diarrhea, febrile neutropenia, ICANS, hypotension, pain, fatigue, headache, encephalopathy, and hemorrhage ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Autolus Inc at toll-free phone 1-855-288-5227 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch ( 17 ). 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of AUCATZYL was evaluated in the FELIX study in which 100 patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) received AUCATZYL at a median dose of 410 × 10 6 CD19 CAR-positive viable T cells (range: 10 to 480 × 10 6 CD19 CAR-positive viable T cells with 90% of patients receiving the recommended dose of 410 × 10 6 ± 25%) [see Clinical Studies (14) ] . The most common serious adverse reactions of any Grade (incidence ≥ 2%) included infections-pathogen unspecified, febrile neutropenia, ICANS, CRS, fever, bacterial infectious disorders, encephalopathy, fungal infections, hemorrhage, respiratory failure, hypotension, ascites, HLH/MAS, thrombosis and hypoxia.

8.1 Pregnancy Risk Summary There are limited available data with AUCATZYL use in pregnant women. In the FELIX study, one patient became pregnant 6 months following treatment with AUCATZYL. The patient had a premature delivery at 30 weeks of pregnancy. No animal reproductive and developmental toxicity studies have been conducted with AUCATZYL to assess whether AUCATZYL can cause fetal harm when administered to a pregnant woman. It is not known if AUCATZYL has the potential to be transferred to the fetus and cause fetal toxicity. Based on the mechanism of action of AUCATZYL, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia and hypogammaglobinemia. Therefore, AUCATZYL is not recommended for women who are pregnant. Pregnancy after AUCATZYL infusion should be discussed with the treating physician. In the U.S. general population, the estimated background risk 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 AUCATZYL in human milk, the effect on the breastfed infant, and the effects on milk production.

Metabolism

The pharmacokinetics (PK) of AUCATZYL were assessed in 90 patients with relapsed or refractory CD19+ B-ALL receiving a median dose of 410 × 10 6 CD19 CAR-positive viable T cells (range: 10 to 480 × 10 6 CD19 CAR-positive viable T cells). Following Day 1 infusion, levels of the AUCATZYL transgene in peripheral blood exhibited an initial rapid expansion.

In FELIX study (all cohorts N=127), occurrences of overdose were observed at the administration of the first dose in 4% (5/127) of patients. All 5 patients had bone marrow blasts > 20% and should have received a first dose of 10 × 10 6 CAR-positive viable T cells but instead received a higher dose between 68 and 103 × 10 6 CAR-positive viable T cells. CRS, ICANS and HLH, including severe events, were observed in patients who received overdose of AUCATZYL. In the event of a suspected overdose, closely monitor patients for any adverse reactions and administer treatment according to institutional practice and treatment guidelines.

1. 1Cytokine Release Syndrome1137%
2. 2Immune Effector Cell-associated Neurotoxicity Syndrome517%
3. 3Pyrexia517%
4. 4Pancytopenia413%
5. 5Acute Lymphocytic Leukaemia Recurrent26.7%
6. 6Asthenia26.7%
7. 7Back Pain26.7%
8. 8Bacteraemia26.7%
9. 9Febrile Neutropenia26.7%
10. 10Full Blood Count Decreased26.7%
11. 11Headache26.7%
12. 12Hyperbilirubinaemia26.7%
13. 13Immune Effector Cell-associated Hlh-like Syndrome26.7%
14. 14Infection26.7%
15. 15Leukaemia Recurrent26.7%

The 8 most recently updated of 8 ClinicalTrials.gov registrations naming Obecabtagene Autoleucel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of Obecabtagene Autoleucel in People With B-cell Acute Lymphoblastic Leukemia
  Recruiting · Phase 2 · Interventional · 40 enrolled · Memorial Sloan Kettering Cancer Center
  NCT07400029updated 2026-05-18
• Phase 2 Study Assessing the Clinical Activity and Safety of Obecabtagene Autoleucel as a Consolidation in Patients With Newly Diagnosed High-risk B-cell Acute Lymphocytic Leukemia (ALL)
  Recruiting · Phase 2 · Interventional · 30 enrolled · M.D. Anderson Cancer Center
  NCT07053059updated 2026-05-05
• Obe-cel in Severe, Refractory Systemic Lupus Erythematosus With Active Lupus Nephritis
  Recruiting · Phase 2 · Interventional · 35 enrolled · Autolus Limited
  NCT07053800updated 2026-04-27
• A Study of CD19 Targeted CAR T Cell Therapy in Adult Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (ALL)
  Active not recruiting · Phase 1 · Phase 2 · Interventional · 153 enrolled · Autolus Limited
  NCT04404660updated 2026-04-08
• Obe-cel in Refractory Progressive Forms of Multiple Sclerosis
  Recruiting · Phase 1 · Interventional · 18 enrolled · Autolus Limited
  NCT07139743updated 2026-03-23
• A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)
  Recruiting · Phase 1 · Interventional · 30 enrolled · Autolus Limited
  NCT06173518updated 2026-03-02
• Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus
  Recruiting · Phase 1 · Interventional · 18 enrolled · Autolus Limited
  NCT06333483updated 2026-02-27
• Expanded Access Program for OOS Obe-cel
  Available · Expanded access · Autolus Limited
  NCT06799221updated 2026-02-27

Frequently asked questions

How does Obecabtagene Autoleucel work?

AUCATZYL is a CD19-directed genetically modified autologous T cell immunotherapy consisting of the patient's own T cells expressing an anti-CD19 CAR. Engagement of anti-CD19 CAR-positive T cells with CD19 expressed on target cells, such as cancer cells and normal B cells, leads to activation of the anti-CD19 CAR-positive T cells and downstream signaling through the CD3-zeta domain.

What is Obecabtagene Autoleucel used for?

According to FDA labeling, Obecabtagene Autoleucel carries indications including: INDICATION AND USAGE AUCATZYL is indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). AUCATZYL is a CD19-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) ( 1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Obecabtagene Autoleucel?

Obecabtagene Autoleucel is classified as Antineoplastic cell and gene therapy, CD19-directed Antibody Interactions.

What are the brand names for Obecabtagene Autoleucel?

Obecabtagene Autoleucel is marketed under brand names including Aucatzyl.

What are the contraindications for Obecabtagene Autoleucel?

Obecabtagene Autoleucel labeling lists contraindications including: None. None ( 4 ).. Always consult the full prescribing information and a clinician.