Aucatzyl (obecabtagene autoleucel) / Autolus - LARVOL DELTA

Can Chimeric Antigen Receptor T-Cell Therapy Be a Definitive Treatment for Adult Relapsed/ Refractory B-Cell Acute Lymphoblastic Leukemia Without Stem Cell Transplant? Long-Term Findings and Predictors of Sustained Remission for Obecabtagene Autoleucel (SOHO 2025) - P1/2 | " Important factors identified from the UVA included: age (3), response status to first/last LOT, previous allogeneic stem-cell transplantation (SCT), and previous inotuzumab ozogamicin... Obe-cel persistence, low disease burden at lymphodepletion, and obe-cel use in earlier lines were associated with better outcomes and longer survival. These data reinforce that obe-cel persistence is important for long-term survival without additional treatments, suggesting the potential of obe-cel as a definitive treatment. Accepted for presentation at the EHA 2025 Congress (Milan, Italy; June 12-15, 2025)."

CAR T-Cell Therapy • Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Obecabtagene autoleucel (obe-cel), a CD19-targeting chimeric antigen receptor (CAR) T-cell therapy, in patients with severe, refractory systemic lupus erythematosus (srSLE): initial safety, preliminary efficacy, pharmacokinetics, and biomarker results from the Phase I CARLYSLE study (EULAR 2026) - No abstract available

Biomarker • Clinical • P1 data • PK/PD data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Obecabtagene Autoleucel in Adults with B-Cell Acute Lymphoblastic Leukemia. (PubMed, N Engl J Med) - P1/2 | "Obe-cel resulted in a high incidence of durable response among adults with relapsed or refractory B-cell ALL, with a low incidence of grade 3 or higher immune-related toxic effects. (Funded by Autolus Therapeutics); FELIX ClinicalTrials.gov number, NCT04404660.)."

Clinical • Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology

Obecabtagene autoleucel, a CD19-targeting autologous chimeric (UKKW 2026) - P1 | "Following lymphodepletion with fludarabine (3×25 mg/m²) and cyclophosphamide (1×1,000 mg/m²), obe-cel was administered as a single starting flat dose of 50×10⁶ (±20%) CAR T-cells... Initial findings from the ongoing CARLYSLE study of obe-cel in srSLE show a manageable safety profile, with no DLTs, ICANS or Grade ≥2 CRS. SLEDAI-2K score reduction and clinical benefit were observed in all patients, including three patients who had a CRR. Despite the short follow up and small number of patients, initial findings are promising; further research is warranted."

Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Glomerulonephritis • Hematological Disorders • Hematological Malignancies • Hypertension • Immunology • Infectious Disease • Inflammatory Arthritis • Leukemia • Lupus • Lupus Nephritis • Nephrology • Neutropenia

OBECABTAGENE AUTOLEUCEL (OBE-CEL) IN RELAPSED/REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKAEMIA (R/R B-ALL): LONG-TERM CLINICAL OUTCOMES IN ADULTS STRATIFIED BY AGE SUBGROUPS OF INTEREST (EBMT 2026) - P1/2 | "ORR (complete remission [CR]/CR with incomplete haematological recovery), duration of remission (DoR), event-free survival (EFS), overall survival (OS), safety, and CAR T-cell persistence are reported for patients aged <55/≥55 (groups elected based on published data that showed shorter OS in patients aged ≥55 vs <55 years treated with blinatumomab/inotuzumab ozogamicin), ≥65 (older adults), ≥18–<40 (vulnerable adolescent and young adults population), and ≥26 years (obe-cel UK NICE recommended/EMA conditional approval population)... Obe-cel treatment was associated with a favourable safety profile, high ORR and a 24-month estimated OS probability between 41% and 49% across all investigated age subgroups. These findings indicate that obe-cel is effective and has a positive benefit-risk profile regardless of patient age, including in older adults with R/R B-ALL, who have poorer long-term outcomes/fewer treatment options."

Clinical • Clinical data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia

CLINICAL OUTCOMES IN ADULT PATIENTS WITH RELAPSED/REFRACTORY ACUTE LYMPHOBLASTIC LEUKAEMIA (R/R B-ALL) WHO ACHIEVED REMISSION FOLLOWING TREATMENT WITH OBECABTAGENE AUTOLEUCEL (OBE-CEL) IN THE FELIX STUDY (EBMT 2026) - P1/2 | "The CRi group were more likely to have received ≥3 lines of prior therapy (42.3% vs 30.1%; prior blinatumomab or inotuzumab ozogamicin: 65.4% vs 43.8%) and had higher median bone marrow blasts at screening (78.5% vs 30.0%) vs the CR group... Most patients with R/R B-ALL who achieved remission following obe-cel achieved CR. Interpretation of long-term outcomes among the CRi group remains limited due to the small number of individuals in this subgroup. A substantial number of patients who responded to obe-cel treatment had a sustained survival benefit, regardless of BOR, with the most pronounced long-term benefit observed in patients who achieved CR."

Clinical • Clinical data • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia

OBECABTAGENE AUTOLEUCEL (OBE-CEL) IN RELAPSED/REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKAEMIA (R/R B-ALL): LONG-TERM CLINICAL OUTCOMES IN ADULTS STRATIFIED BY AGE SUBGROUPS OF INTEREST (EBMT 2026) - P1/2 | "ORR (complete remission [CR]/CR with incomplete haematological recovery), duration of remission (DoR), event-free survival (EFS), overall survival (OS), safety, and CAR T-cell persistence are reported for patients aged <55/≥55 (groups elected based on published data that showed shorter OS in patients aged ≥55 vs <55 years treated with blinatumomab/inotuzumab ozogamicin), ≥65 (older adults), ≥18–<40 (vulnerable adolescent and young adults population), and ≥26 years (obe-cel UK NICE recommended/EMA conditional approval population)... Obe-cel treatment was associated with a favourable safety profile, high ORR and a 24-month estimated OS probability between 41% and 49% across all investigated age subgroups. These findings indicate that obe-cel is effective and has a positive benefit-risk profile regardless of patient age, including in older adults with R/R B-ALL, who have poorer long-term outcomes/fewer treatment options."

Clinical • Clinical data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia

Obecabtagene autoleucel (Obe-cel) in the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia (PubMed, Bull Cancer) - No abstract available

Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

CD19-targeting chimeric antigen receptor (CAR) T-cell therapy, obecabtagene autoleucel (obe-cel), in severe refractory systemic lupus erythematosus (srSLE): initial results from Phase I CARLYSLE study (LUPUS 2026) - P1 | "All patients showed deep B-cell depletion post-infusion; >90% of reconstituted B-cells at time of recovery (median: 6.0 months) were transitional and naïve (50M cohort).Abstract LBS1:02 Figure 1Change in SLEDAI-2K score over time in adult patients infused with obe-cel at the 50M or 100M doseAbstract LBS1:02 Table 1Safety outcomes in adult patients infused with obe-cel at the 50M or 100M dose Conclusions In these preliminary findings of obe-cel in srSLE, obe-cel demonstrated a favourable safety profile and clinical benefit despite severe baseline disease activity. Emerging data in the 100M cohort are consistent with the 50M cohort; evaluation is ongoing."

Late-breaking abstract • P1 data • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Systemic Lupus Erythematosus

AUTO1-SL2: A SINGLE-ARM, OPEN-LABEL, PHASE II STUDY TO DETERMINE THE SAFETY AND EFFICACY OF OBECABTAGENE AUTOLEUCEL (OBE-CEL) IN PARTICIPANTS WITH SEVERE, REFRACTORY SYSTEMIC LUPUS ERYTHEMATOSUS WITH ACTIVE LUPUS NEPHRITIS (clinicaltrialsregister.eu) - P1/2 | N=3 | Not yet recruiting | Sponsor: Autolus Limited

New P1/2 trial • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology • Systemic Lupus Erythematosus

CARLYSE: Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=18 | Recruiting | Sponsor: Autolus Limited | Trial completion date: Dec 2026 ➔ Sep 2027 | Trial primary completion date: Dec 2025 ➔ Sep 2027

Trial completion date • Trial primary completion date • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Colitis Reporting in the Era of CAR-T Cell Therapies: Opposing Signals from Global Pharmacovigilance Data (ECCO-IBD 2026) - "Conclusion This global pharmacovigilance study identified a novel safety concern of IMC following BCMA-directed CAR-T therapy, but not after CD19-directed constructs. These findings suggest a distinct, target-dependent effect of CAR-T therapy on intestinal immunity."

Adverse events • CAR T-Cell Therapy • Clinical • Immunology • Inflammatory Bowel Disease • Ulcerative Colitis

Impact of Chimeric Antigen Receptor (CAR) Product Cell Phenotypes on Clinical Outcomes Following Treatment with Obecabtagene Autoleucel (Obe-cel) (EHA-EBMT-CART 2026) - P1/2 | "The OS MVA model included Philadelphia chromosome status, prior inotuzumab ozogamicin (InO), bone marrow blasts at lymphodepletion, and CAR T-cell persistence...High-T cm DP samples displayed enhanced proliferative and polyfunctional responses versus low-T cm DP. Table Clinical Trial Registry : NCT04404660"

Clinical • Clinical data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • CD19 • CD4 • CD8 • HAVCR2 • IL2RA • ISG20 • LAG3 • PD-1

A Study of Obecabtagene Autoleucel in People With B-cell Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P2 | N=40 | Recruiting | Sponsor: Memorial Sloan Kettering Cancer Center

New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19

Evaluating the Safety, Tolerability and Preliminary Efficacy of Obecabtagene autoleucel in Patients with Refractory Progressive Forms of Multiple Sclerosis: The BOBCAT Trial (ACTRIMS Forum 2026) - P1 | "Eligible patients will undergo lymphodepletion using a standard fludarabine-cyclophosphamide regimen prior to obe-cel infusion... BOBCAT is an ongoing study enrolling patients with PMS, or RRMS who meet PIRA criteria, who are refractory to prior DMTs. The trial is recruiting at sites in the UK, Spain, and the US.Funding: This study was sponsored by Autolus Therapeutics PLC."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • CNS Disorders • Hematological Malignancies • Immunology • Inflammatory Arthritis • Leukemia • Lupus • Multiple Sclerosis • Systemic Lupus Erythematosus • NEFL

Treatment of Pediatric Patients with relapsed/refractory B-cell Acute Lymphoblastic Leukemia with Obecabtagene Autoleucel, a CD19-Directed Chimeric Antigen Receptor T-cell Therapy: Preliminary Findings from the Phase Ib/II CATULUS Trial (TCT-ASTCT-CIBMTR 2026) - P1 | "In the Phase I CARPALL study (NCT02443831), obe-cel showed promising efficacy and safety in pediatric R/R B-ALL (Ghorashian S, et al...Eligible pts (<18 years, with primary refractory R/R B-ALL/high-risk first relapse/≥2 relapses) underwent lymphodepletion (fludarabine 4×30 mg/m 2; cyclophosphamide 2×500 mg/m 2 ), followed by a single obe-cel infusion (target dose: 1.0×10 6 /kg CAR T-cells)...3 . To demonstrate the successful manufacture and pharmacokinetics of a single-dose infusion of obe- cel in pediatric patients at the target dose of 1.0×10 6 /kg chimeric antigen receptor T-cells."

CAR T-Cell Therapy • Clinical • P1/2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Pediatrics

Geographic Distribution and Racial Disparities of CAR-T cell Therapy Centers in the United States (TCT-ASTCT-CIBMTR 2026) - "Product availability varied: tisa-cel was offered at 118 centers, axi-cel and brexu-cel at 160 each, ide-cel and liso- cel at 159 each, cilta-cel at 125, and obe-cel at 53... Although CAR-T centers are distributed nationwide, per-capita access remains limited, particularly in large, minority-dense states. Regions with substantial Hispanic and AA populations demonstrate underrepresentation in CAR-T therapy access relative to their population size, highlighting the need to expand treatment infrastructure to reduce racial and geographic disparities in CAR-T availability. 1."

CAR T-Cell Therapy • Hematological Malignancies

Mapping Gaps: Geographic and Racial Disparities in CAR-T cell Therapy Access for Multiple Myeloma and B-ALL in the United States (TCT-ASTCT-CIBMTR 2026) - "Obe-cel, Tisa-cel and Cilta-cel remained less widely distributed compared to Ide-cel, Axi-cel and Liso-cel, and were absent in multiple states (Obe-cel was not available in 27 states, Tisa-cel in 11 and Cilta-cel in 8). Significant racial inequities exist in CAR-T access for both MM and B-ALL. African Americans have limited availability of anti-BCMA therapies (Ide-cel, Cilta-cel) in high-AA states, while Hispanics face similarly restricted access to B-ALL products (Tisa-cel, Brexu-cel, Obe-cel) in Hispanic-dense regions. Targeted expansion of CAR-T centers is critical to achieving equitable access for these high-burden populations."

CAR T-Cell Therapy • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Multiple Myeloma

Validation of a Multiplexed Quantitative PCR Assay for Obecabtagene Autoleucel CAR T cell Expansion and Persistence Monitoring (TCT-ASTCT-CIBMTR 2026) - "Monitoring of CAR T cell persistence can provide important insights into efficacy, durability of response and toxicity. While molecular CAR T cell testing options are commercially available for other anti-CD19 therapies, this has been unavailable to most obe-cel patients outside of clinical trials due to the novel antigen binding domain. This validated obe-cel assay demonstrated excellent performance and will provide rapid and accurate monitoring of CAR T cell dynamics in patients receiving this therapy."

CAR T-Cell Therapy • Hematological Malignancies

Real-World Cost of Cytokine Release Syndrome (CRS) and Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) Following CAR T-cell Therapy, in US Adults with B-ALL (TCT-ASTCT-CIBMTR 2026) - "The frequency of CRS/ICANS observed in this real-world cohort is consistent with those reported in clinical trials and other real-world studies. Our analysis shows the considerable operational burden and financial costs associated with CRS and ICANS, and highlights the substantial impact of high- grade events. Newer CAR T-cell therapies, such as obecabtagene autoleucel which has been associated with low rates of high-grade CRS (2%) and ICANS (7%), could potentially alleviate some of the pressures experienced by healthcare systems and pts/caregivers."

CAR T-Cell Therapy • Clinical • Cytokine release syndrome • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Inflammation • Leukemia

Chimeric Antigen Receptor T-cell Persistence at Month 3 Predicts Clinical Outcomes In Adult Patients with relapsed/refractory B-cell Acute Lymphoblastic Leukemia Treated with Obecabtagene Autoleucel (TCT-ASTCT-CIBMTR 2026) - P1/2 | "3 . To recognize the potential of droplet digital polymerase chain reaction measured CAR T-cell persistence at Month 3 as a predictive biomarker for long-term treatment success following obe-cel therapy."

CAR T-Cell Therapy • Clinical • Clinical data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia

Patient Characteristics, Toxicity, and Response after Real World Administration of Obecabtagene Autoleucel and Brexucabtagene Autoleucel for Relapsed Acute Lymphoblastic Leukemia: A Rocca Analysis (TCT-ASTCT-CIBMTR 2026) - "A larger sample and longer follow up are required for further analyses; we anticipate a cohort of ~75 obe-cel treated pts by the annual meeting and will provide updated data. 1) Understand the real world toxicity of obecabtagene autoleucel 2) Describe early results of the real world efficacy of obecabtagene autoleucel 3) Compare toxicity and efficacy in the real world between obecabtagene autoleucel and brexucabtagene autoleucel for the treatment of R/R ALL"

Clinical • IO biomarker • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • Cerebral Hemorrhage • Hematological Disorders • Hematological Malignancies • Hepatology • Infectious Disease • Leukemia • Liver Failure • Neutropenia

EFFICACY AND SAFETY OUTCOMES OF OBECABTAGENE AUTOLEUCEL (OBE-CEL) STRATIFIED BY AGE IN PATIENTS WITH RELAPSED/REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (R/R B-ALL) (EHA 2025) - P1/2 | "A higher proportion of pts aged <55 years were Hispanic/Latino (36.7% vs 18.8%), had extramedullary disease at lymphodepletion (29.1% vs 8.3%), and had received prior blinatumomab (53.2% vs 22.9%), and/or prior inotuzumab ozogamicin (35.4% vs 25.0%) vs those aged ≥55 years... Obe-cel treatment was associated with deep and durable remissions resulting in favorable ORR, EFS, and OS with low incidence of Grade ≥3 CRS and ICANS in both age groups. These findings indicate that obe-cel is effective and has a positive benefit and risk profile regardless of pt age, including in older adults with R/R B-ALL, despite few pts receiving consolidative SCT"

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Obecabtagene autoleucel (obe-cel, AUTO1) in adults with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL): Overall survival (OS), event-free survival (EFS) and the potential impact of chimeric antigen receptor (CAR)-T cell persistency and consolidative stem cell transplantation (SCT) in the open-label, single-arm FELIX phase Ib/II study. (ASCO 2024) - P1/2 | "Pts received bridging therapy as appropriate and underwent lymphodepletion (fludarabine, 4×30mg/m 2; cyclophosphamide, 2×500mg/m 2 ), followed by obe-cel split dose infusions on Days 1 and 10 based on pre-lymphodepletion leukemic burden at a target dose of 410×10 6 CAR-T cells...At screening, pts' median age was 47 yrs; 42%/31%/44% had received prior blinatumomab/inotuzumab ozogamicin/allogeneic SCT; median bone marrow blast burden was 36% (range: 0−100)... Ongoing CAR-T cell persistency and B-cell aplasia were associated with improved EFS without further consolidation post-obe-cel. At the current follow-up, consolidative SCT for pts in MRD-negative remission post-obe-cel did not improve EFS or OS."

Clinical • P1/2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation

CAN CAR T-CELL THERAPY BE A DEFINITIVE TREATMENT FOR ADULT R/R B-ALL WITHOUT TRANSPLANT? LONG-TERM FINDINGS AND PREDICTORS OF SUSTAINED REMISSION FOR OBECABTAGENE AUTOLEUCEL (EHA 2025) - P1/2 | "Stepwise variable selection was performed to identify the list of important factors in the final model.Important factors identified from the UVA included: age (3), response status to first and last line of therapy, previous allogeneic SCT and previous inotuzumab ozogamicin prior to leukapheresis... Obe-cel persistence, low disease burden at LD and obe-cel use in earlier lines were independent factors associated with better outcomes and longer survival in adult pts with R/R B-ALL. These data re-enforce that obe-cel persistence is important in achieving long-term survival without additional treatments, suggesting the potential of obe-cel as a definitive treatment."

CAR T-Cell Therapy • Clinical • Transplantation