Aucatzyl (obecabtagene autoleucel) / Autolus - LARVOL DELTA

Obecabtagene autoleucel (obe-cel), a CD19-targeting Chimeric Antigen Receptor (CAR) T-cell Therapy, in Adults and Adolescents with Severe, Refractory Systemic Lupus Erythematosus (srSLE): Findings from the Phase I CARLYSLE Study (ACR Convergence 2026) - No abstract available

Clinical • P1 data • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

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

COMBINATION THERAPY WITH BLINATUMOMAB AND ASCIMINIB FOR PHILADELPHIA CHROMOSOME-POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA: RESULTS FROM A PHASE I/II STUDY (EHA 2026) - "Summary/Conclusion In this ongoing phase I/II study, the combination of blinatumomab + asciminib is safe and highly effective in pts with R/R Ph+ ALL, including those with prior exposure to blinatumomab + ponatinib...The study continues to accrue R/R pts. Given the encouraging activity observed in the R/R population, the study has been expanded to also enroll frontline pts ≥18 years of age."

Combination therapy • P1/2 data • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Movement Disorders • ABL1

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

Autolus Therapeutics plc…announced today that the U.S. Food and Drug Administration has granted regenerative medicine advanced therapy designation to obecabtagene autoleucel for the treatment of systemic lupus erythematosus and lupus nephritis. (Investing.com) - "The designation for obe-cel is based on Phase 1b data from the CARLYSLE trial....The company submitted the next data update from the Phase 1 CARLYSLE trial in patients with SLE for presentation at the American College of Rheumatology Annual Meeting in the fourth quarter of 2026. The LUMINA Phase 2 study of obe-cel in patients with refractory lupus nephritis is enrolling in five countries. Autolus expects to report data from the study in 2028."

FDA event • P1 data • P2 data • Immunology • Lupus Nephritis • Systemic Lupus Erythematosus

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

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

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

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

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

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

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

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

The effect of obecabtagene autoleucel (obe-cel) on adult patients (pts) with relapsed/refractory B-cell acute lymphoblastic leukemia (R/R B-ALL) and extramedullary disease (EMD). (ASCO 2026) - P1/2 | "Obe-cel treatment demonstrated favorable efficacy and safety outcomes in pts with and w/o EMD in the FELIX trial. Among responders, DoR in pts with EMD was comparable with that observed in pts w/o EMD. Overall, these findings support a positive benefit–risk profile for obe-cel, irrespective of EMD status at LD."

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

Clinical Outcomes in Adult Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia Who Achieved Remission Following Treatment With Obecabtagene Autoleucel in the FELIX Study (SOHO 2026) - P1/2 | "Most patients with R/R B-ALL who achieved remission following obe-cel achieved CR (n = 73/99; 74%); most patients in CRi recovered blood counts and achieved CR within 3 months. A substantial number of patients who responded to obe-cel treatment showed sustained survival benefits, regardless of BOR. Late platelet-count recovery after 3 months was not associated with bleeding events."

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

The Effect of Obecabtagene Autoleucel on Adult Patients With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia and Extramedullary Disease (SOHO 2026) - P1/2 | "Obe-cel treatment demonstrated favorable efficacy and safety outcomes in patients with and without EMD in the FELIX trial. Among responders, DoR in patients with EMD was comparable with that observed in patients without EMD. Overall, these findings support a positive benefit-risk profile for obe-cel, irrespective of EMD status at lymphodepletion."

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

Improving Efficacy and Safety Outcomes in Patients With Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia in Morphologic Remission Treated With Obecabtagene Autoleucel (SOHO 2026) - P1/2 | "Obe-cel demonstrated efficacy regardless of BM blast percentage at screening/lymphodepletion, with comparable EFS and low CRS/ICANS incidence in patients who had <5% BM blasts before/after BT. These data suggest that the best outcomes occurred when the BM blast percentage was low/effectively reduced by BT. The poorerHHgroup results may indicate high-risk biology or a need to optimize BTs."

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

The UK has become the first country in the world to recruit patients into a new Phase II clinical trial for a groundbreaking systemic lupus erythematosus (lupus) treatment. (NIHR) - "Cambridge University Hospitals NHS Foundation Trust (CUH) is the first UK site to offer the pioneering, one-off CAR-T cell therapy to patients following a successful Phase I trial...This local success was supported by the UK Vaccine Innovation Pathway (UKVIP), part of our Life Sciences Industry Hub. The Hub worked in partnership with the sponsor and clinical teams to proactively anticipate and manage study-wide issues throughout the set-up process, avoiding delays and ensuring rapid resolution...Crucially, this trial showcases research delivery capability for highly controlled specialist environments required for advanced cell therapies. It provides sponsors like Autolus with the confidence to run complex, global trials in the UK."

Trial status • Lupus • Systemic Lupus Erythematosus

KCAT19: Allogeneic T Cells Expressing T Cell Receptor-KDEL and the Chimeric Antigen Receptor CAT19 for the Treatment of Advanced CD19+ Malignancies (clinicaltrials.gov) - P1 | N=12 | Recruiting | Sponsor: University College, London | Not yet recruiting ➔ Recruiting | Trial completion date: Nov 2034 ➔ Feb 2040 | Trial primary completion date: Nov 2024 ➔ Feb 2027

Enrollment open • Trial completion date • Trial primary completion date • Hematological Malignancies • Oncology

Obecabtagene Autoleucel in Relapsed/Refractory B-ALL: A Critical Review of Clinical Efficacy and Safety. (PubMed, Ann Pharmacother) - "While logistical complexities and high acquisition costs remain an access barrier to CAR-T cell therapies, obe-cel's molecular design and safety profile represent a significant advancement in the care of patients with R/R B-ALL."

Journal • Review • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

CARLYSE: Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus (clinicaltrials.gov) - P1 | N=16 | Active, not recruiting | Sponsor: Autolus Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Immunology • Inflammatory Arthritis • Lupus • Systemic Lupus Erythematosus

Comparison of obecabtagene autoleucel versus an external control arm in adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia. (PubMed, Leukemia) - P1/2 | "ECAs represented standard of care (SoC) non-CAR T-cell therapies: blinatumomab, inotuzumab ozogamicin, and conventional chemotherapy...Safety profiles were comparable between groups, with similar rates of Grade ≥3 adverse events. Obe-cel offers superior remission rates and survival benefits over current SoC non-CAR T-cell therapies, with an acceptable safety profile; its use could address unmet needs in adult R/R B-ALL."

Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation

False-positive HIV-1 RNA detection following obecabtagene autoleucel. (PubMed, Bone Marrow Transplant) - No abstract available

Journal • Human Immunodeficiency Virus • Infectious Disease

Immune effector cell-associated hematotoxicity following CAR-T cell therapies: insights from a large national database. (PubMed, Jpn J Clin Oncol) - "Axicabtagene ciloleucel had the highest case count (n = 18) and most precisely estimated ROR (1365.54; 95% CI: 778.83-2394.24)...No ICAHT reports were identified for obecabtagene autoleucel or tisagenlecleucel, with the former having minimal post-marketing data and the latter potentially reflecting genuine mechanistic differences related to its 4-1BB co-stimulatory domain. These findings demonstrate that ICAHT generates exceptionally strong and concordant pharmacovigilance signals across multiple CAR-T products, supporting heightened post-infusion hematologic monitoring with a low threshold for investigating unexplained cytopenias."

Journal • Bone Marrow Transplantation • Hematological Disorders • Transplantation