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

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

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

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

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

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

PREDICTING HEMATOTOXICITY RISK AND OUTCOMES IN RELAPSED/REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (R/R B-ALL): SHOULD HEMATOTOX MODELS BE CAR SPECIFIC RATHER THAN DISEASE SPECIFIC (EHA 2025) - P1/2 | "A higher proportion of CAR-HT low-risk (80.0%) vs high-risk pts (51.0%) received prior blinatumomab or inotuzumab ozogamicin... Although both models show potential, ALL-HT appears to improve risk stratification and may be a better predictor of response, survival and safety outcomes in adult pts with R/R B-ALL treated with obe-cel, than CAR-HT. Taken together with other published reports, our data suggest that the strength of HT-model predictions may be CAR specific. Further analyses are needed."

Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Hematological Malignancies • Infectious Disease • Large B Cell Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CRP

OBECABTAGENE AUTOLEUCEL IN ADULT RELAPSED/REFRACTORY B CELL ACUTE LYMPHOBLASTIC LEUKEMIA: SURVIVAL AND POTENTIAL IMPACT OF CAR-T CELL PERSISTENCE AND STEM CELL TRANSPLANTATION IN THE FELIX STUDY (EHA 2024) - P1/2 | "Patients received bridging therapy as appropriate and underwent lymphodepletion ( fludarabine, 4×30mg/m2; cyclophosphamide, 2×500mg/m2 )...At screening, patients ' median age was 47 years, and 42%, 31%, and 44% of patients had received prior blinatumomab, inotuzumab ozogamicin, or allogeneic SCT, respectively... Without further consolidation post-obe-cel, ongoing CAR-T cell persistence and B cell aplasia were associated with improved EFS. At the current follow-up, consolidative SCT for patients in MRD-negative remission post- obe-cel did not improve EFS or OS. Longer follow-up is needed to validate the requirement of consolidative SCT post-obe-cel."

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

Obecabtagene Autoleucel (obe-cel, AUTO1) for Relapsed/Refractory Adult B-cell Acute Lymphoblastic Leukemia (R/R B-ALL): Pooled Analysis of the Ongoing FELIX Phase Ib/II Study (ASH 2023) - P1/2 | "Pts received bridging therapy as needed and lymphodepletion with fludarabine (4 × 30mg/m2) and cyclophosphamide (2 × 500mg/m2)...Baseline characteristics at screening (n=126): median age 46.5 (range 20–81) yrs; Philadelphia positive B-ALL 27%; median 2 (range 1–6) prior lines of therapy; prior blinatumomab/inotuzumab 42%/32%; median BM blast burden 37% (range 0–100) including 23% pts with EMD; prior allogeneic stem cell transplant 44%... This pooled analysis of data from all pts treated to date in the FELIX study demonstrates high rates of CR/CRi after obe-cel treatment, durable responses (median DoR not reached), and a favorable safety profile. Preliminary data suggest better outcomes in pts with low leukemia burden at screening/lymphodepletion, with higher rates of deep MRD negative complete remission, median DoR not reached at the current follow up, no Gr ≥3 CRS and one Gr ≥3 ICANS. These data support further exploration of CAR T therapy earlier in..."

P1/2 data • Retrospective data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

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

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

Safety, Efficiency and Long-Term Follow-up of AUTO1, a Fast-Off Rate CD19 CAR in Relapsed/Refractory B-Cell Acute Lymphoblastic Leukaemia and Other B-Cell Malignancies (ASH 2022) - P1 | "Study design: Subjects ≥ 16y received fludarabine (30mg/m2 x3) and cyclophosphamide (60mg/kg x1) conditioning. DLBCL patients additionally received pembrolizumab (200mg) on day -1... AUTO1 has a tolerable safety profile in patients with r/r B-cell cancers despite high disease burden. In the B-ALL cohort, long-term follow-up indicates that 40% of patients continue in remission post-AUTO1. In both indolent and aggressive NHL and in CLL, AUTO1 shows excellent ORR and CAR engraftment/persistence."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Novel Coronavirus Disease • Oncology • Pediatrics • CD19

Safety and efficacy of obecabtagene autoleucel (obe-cel, AUTO1), a fast-off rate CD19 CAR, in relapsed/refractory adult B-cell acute lymphoblastic leukemia (r/r B-ALL): Top line results of the pivotal FELIX study. (ASCO 2023) - P1, P1/2 | "Its clinical activity has been tested in r/r paediatric and adult B-ALL trials (CARPALL, Ghorashian S et al., Nat Med 2019; ALLCAR19, Roddie C et al., JCO 2021) and more recently in adults with r/r B-cell malignancies (NCT02935257)...Patients underwent bridging therapy as necessary and lymphodepletion with fludarabine (4x30mg/m2) and cyclophosphamide (2x500mg/m2)... The pre-specified interim analysis of the FELIX study demonstrated that obe-cel for adult r/r B-ALL is safe with low rates of Grade >3 CRS and/or ICANS, even in patients with high burden disease. Obe-cel is effective with high CR/CRi rates and ongoing CAR T persistence in the majority of responders. The trial has completed dosing of all patients in Cohort A. Additional data and longer follow up will be reported at the conference."

Clinical • Acute Lymphocytic Leukemia • Anemia • B Acute Lymphoblastic Leukemia • Febrile Neutropenia • Hematological Disorders • Hematological Malignancies • Leukemia • Neutropenia • Oncology • Pediatrics • Transplantation

CD19/CD22 targeting with co-transduced CAR T-cells to prevent antigen negative relapse after CAR T-cell therapy of B-ALL. (PubMed, Blood) - P1 | "Twelve patients with advanced B-ALL were treated (CARPALL study, NCT02443831), a third of whom had failed prior licensed CAR therapy...Six and 12-month event free survival (EFS) were 75% (95%CI: 41-91%) and 60% (95%CI: 23-84%). These data suggest dual targeting with co-transduction may prevent antigen negative relapse after CAR T-cell therapy."

CAR T-Cell Therapy • Journal • Inflammation • CD22

Tumor burden-guided dosing contributes to mitigation of immunotoxicities following treatment with obecabtagene autoleucel in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia. (PubMed, Haematologica) - P1/2 | "Although further study is needed to better characterize the effects of the split-dosing strategy, the clinical evidence supports its use when administering obe-cel for the treatment of R/R B-ALL. Trial registration number: NCT04404660 (www.clinicaltrials.gov)."

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

Autolus Therapeutics Presents Updated Clinical Data from the CARLYSLE Trial in Patients with Severe Refractory Systemic Lupus Erythematosus at the American Society of Hematology (ASH) Annual Meeting 2025 (The Manila Times) - "Obe-cel was well tolerated in all patients. No dose limiting toxicities (DLTs) or cases of immune effector cell-associated neurotoxicity syndrome (ICANS) were observed at the 50M dose....At the 50M dose, three patients (50%) achieved CRR and five patients (83%) achieved DORIS with a median onset of 5.1 months (range: 4.9-8.9), without evidence of new disease activity at a median of 12 months of follow up (range: 8.5-16.3). All non-renal manifestations of the disease resolved by month four....Based on this positive initial experience with obe-cel in the CARLSYLE trial we have initiated the LUMINA trial, a Phase 2 trial in lupus nephritis with registrational intent."

P1 data • Trial status • Systemic Lupus Erythematosus

Efficacy and safety profile of obecabtagene autoleucel as a CAR T-cell therapeutic agent (ASH 2025) - "2 Conclusion - The progress in CAR T-cell therapies has transformed healthcare; however, challenges such as severe cytokine release syndrome (CRS) and related neurotoxicity have hindered their broader application. Obecabtagene autoleucel is an innovative drug."

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

A post-marketing pharmacovigilance analysis of cardiotoxicities following chimeric antigen receptor T-cell therapy using the FDA adverse event reporting system (ASH 2025) - "Therefore, a post-marketing pharmacovigilance analysis of the cardiac AEs reported to the FDAAdverse Event Reporting System (FAERS) for each CAR-T product was conducted to address thisknowledge gap. All individual case safety reports of cardiac AEs listing any of the approved CAR-T therapies[Tisagenlecleucel (Tisa-cel), Axicabtagene ciloleucel (Axi-cel), Lisocabtagene maraleucel (Liso-cel),Brexucabtagene autoleucel (Brexu-cel), Idecabtagene vicleucel (Ide-cel), Ciltacabtagene autoleucel (Cilta-cel) and Obecabtagene autoleucel (Obe-cel)] as the suspected drug were identified from the FAERSdatabase... This post-marketing pharmacovigilance analysis highlights patterns of cardiac AEs followingCAR-T therapy. Trends in AEs based on CAR-T product, age, and sex support the ongoing need forvigilance for these unique toxicities. As this study is limited by FAERS reporting bias, prospective studiesto validate these associations and elucidate the underlying mechanisms are needed,..."

Adverse events • CAR T-Cell Therapy • P4 data • Acute Coronary Syndrome • Acute Lymphocytic Leukemia • B Cell Non-Hodgkin Lymphoma • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Malignancies • Hypotension • Leukemia • Lymphoma • Multiple Myeloma • Myocardial Infarction • Non-Hodgkin’s Lymphoma • Thrombosis • ROR1

Chimeric antigen receptor (CAR) T-cell persistence at month 3 predicts clinical outcomes in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) treated with obecabtagene autoleucel (obe-cel) (ASH 2025) - P1/2 | "In patients who remained in remission beyond M3, including those with deep MRD-negative remissionand no post obe-cel SCT, ongoing CAR T-cell persistence at M3, measured by ddPCR, was associated withlonger EFS and OS compared with loss of persistence. Persistence status at M3 may be a marker forpredicting long-term outcomes following obe-cel treatment in patients with R/R B-ALL."

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