Besponsa (inotuzumab ozogamicin) / Pfizer - LARVOL DELTA

Efficacy and Safety of the Third-Generation Tyrosine Kinase Inhibitor Olverembatinib in Combination With Inotuzumab Ozogamicin for the Treatment of Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia Patients With Refractory/Relapsed Disease or Persistent Minimal Residual Disease Bridging to Hematopoietic Stem Cell Transplantation. (PubMed, Am J Hematol) - No abstract available

Journal • Minimal residual disease • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology • Transplantation

Venetoclax plus inotuzumab ozogamicin for relapsed and refractory ALL: Results of a phase I trial (ASH 2025) - P1 | "Due to distinct mechanisms of action and non-overlapping toxicities, we hypothesized that adding VEN to INO would be safe and effective. This investigator-sponsored phase I study (NCT05016947) enrolled pts ≥18 years with CD22+ (≥20% ofblasts) R/R ALL (≥5% bone marrow [BM] blasts) or lymphoblastic lymphoma (LBL, BM <5% blasts).Philadelphia chromosome-negative (Ph-) pts had received ≥1 line of therapy; Ph+ pts were ponatinib(PON)-refractory or ineligible...Dexamethasone (10 mg/m2) was given during Lead-In and D1-4 of C1 Induction...BH3 profiling showed that ptsMRD- by C2 had lower pre-treatment mitochondrial apoptotic priming.Of the 21 CR patients, 1 pt (KMT2Ar) progressed during C2, and the remaining 20 pts (95.2%) wereconsolidated with blinatumomab (n=9, 42.9%), SCT (n=14, 66.7%, 6 after blinatumomab), DLI (n=1), XRT(n=1), or POMP (n=1)... VEN can be safely added to INO in pts with R/R CD22+ ALL/LBL including Ph+ ALL, with a very high anddurable rate of MRD- CR...."

P1 data • CNS Disorders • Febrile Neutropenia • Gastrointestinal Disorder • Hepatology • Lymphoblastic Lymphoma • Lymphoma • Neutropenia • Thrombocytopenia • KMT2A

Addition of Inotuzumab to a Pediatric Inspired Chemotherapy Regimen in Young Adult Patients with B-Cell Acute Lymphoblastic Leukemia: Findings from the Alliance A041501 Phase 3 Randomized Trial (ASH 2024) - P3 | "Eligible pts received the CALGB 10403 regimen modified to omit extended induction, include dexamethasone as opposed to prednisone as steroid backbone, cap the pegaspargase dose to 3750 units, and adding rituximab for pts with CD20 expression (> 20%). INO may still be efficacious if late toxicity can be mitigated. A pilot study is planned that will decrease INO dose, add 2 cycles of blinatumomab and strict infectious prophylaxis guidelines."

Clinical • P3 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Developmental Disorders • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Pediatrics • Septic Shock • ABL1 • CD20 • CD22

Inotuzumab ozogamicin then blinatumomab for older adults with newly diagnosed, ph-negative, CD22-positive, B-cell acute lymphoblastic leukemia: Extended follow-up of alliance for clinical trials in oncology A041703 cohort 1 reveals durable remission and survival (ASH 2025) - "Longer follow-up of chemotherapy-free treatment with InO and blina for older pts withnewly diagnosed, Ph-negative, CD22-positive, B-cell ALL reveals durable remissions and survival. TheA041703 regimen is a compelling option for first-line treatment of this pt population.Support: U10CA180821, U10CA18088; https://acknowledgments.alliancefound.org."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Breast Cancer • CNS Disorders • Hematological Malignancies • Hepatology • Leukemia • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Solid Tumor • CD22 • TP53 • ZNF384

The growing armamentarium of agents for older adults with ALL (YouTube) - "Marlise Luskin, MD, MSCE...highlights the expanding treatment options for older adults with acute lymphoblastic leukemia (ALL), including inotuzumab ozogamicin and blinatumomab. She also comments on the potential of venetoclax as an alternative for patients who cannot receive inotuzumab or blinatumomab, and explains that combining available agents to create effective regimens is an ongoing investigative goal."

Interview • Video

Blinatumomab, inotuzumab & venetoclax in older patients with ALL: practical considerations (YouTube) - "Marlise Luskin, MD, MSCE...shares insights into the treatment of older adults with acute lymphoblastic leukemia (ALL), emphasizing the importance of improving efficacy while reducing toxicity in this patient population. Dr Luskin highlights the potential of agents such as inotuzumab ozogamicin, blinatumomab, and venetoclax, each with its own advantages and challenges, and notes that ongoing trials are investigating how to best combine these agents to achieve optimal outcomes."

Interview • Video

CD19-CAR T cell therapy as a definitive consolidation in older adults with b-ALL in CR1 is safe and induces durable MRD- remission (ASH 2025) - P1 | "2022), administered following LD with fludarabine and cyclophosphamide.Pts are followed for toxicity and minimal residual disease (MRD) relapse by flow cytometry (FC) andclonoSEQ (if feasible) every 3 months for 2 years...Six pts had Ph+, 5 hadnot otherwise specified (NOS), 2 had hypodiploidy/TP53m, 2 had CRLF2-rearranged Ph-like, 1 each hadKMT2Ar, EP300::ZNF384, and TCF3::PBX1; 15 (83%) and 2 (11%) pts received blinatumomab andinotuzumab as part of initial therapy, respectively...A second pt (75 yrs old; received induction with hyper CVAD +inotuzumab) developed therapy-related myelodysplastic syndrome 18 months post CAR-T... The use of CAR-T in older adults with B-ALL in MRD- CR1 is safe, with the only encounteredtoxicity of G1 CRS, which was manageable. CAR-T cells expanded in the blood and CSF despite the lowantigen setting. We observed preliminary durable MRD- CR with preserved function and cognition on day100 post CAR-T."

CAR T-Cell Therapy • Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • CRLF2 • EP300 • KMT2A • PBX1 • TCF3 • ZNF384

Primary efficacy analysis of phase II study investigating tyrosine kinase inhibitor (TKI) and inotuzumab ozogamicin-based therapy for newly diagnosed Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL) (ASH 2025) - "Tyrosine kinase inhibitor (TKI) + blinatumomab regimenshave demonstrated high MR4 rates and favorable overall survival (OS); however, these regimens includeup to 5 courses of blinatumomab which is a continuous 28-day infusion (Kantarjian et al, JCO 2024; Foa etal, JCO 2024)...Eligibilitycriteria includes newly diagnosed Ph+ ALL, age ≥ 18, ECOG ≤2, CD22+ on ≥20% blasts, and no centralnervous system (CNS) disease.Schema 1 was as follows; Course (C) 1 was (28 days) dasatinib (DAS) 140mg daily, dexamethasone (dex)10mg/m2 D1-7 & D15-21, and InO 0.8mg/m2 D8, 0.5mg/m2 D15 and D22...If MR4 was not achieved by end of C2 (EOC2), DAS was switched to ponatinib(PON)...TKI + InO-based therapy for newly diagnosed pts with Ph+ ALL has an MR3+ rate of 81% within 2 coursesand 100% of pts achieved MR4 and/or NGS MRD- disease by EOC3. No cases of VOD were seen withSchema 2. Given the excellent rates of MR3+ with limited cycles of InO, further development of thisinduction approach is..."

Clinical • P2 data • Acute Lymphocytic Leukemia • CNS Disorders • Hematological Malignancies • Hepatology • Infectious Disease • Leukemia • Pulmonary Disease • Respiratory Diseases • Septic Shock • IKZF1

Brexucabtagene autoleucel (Brexucel) as a consolidation therapy in B-cell acute lymphoblastic leukemia (B-ALL) post HCVAD/minihcvd-inotuzumab-blinatumomab regimens: Initial Results of a prospective Phase 2 trial. (ASH 2025) - P1/2 | "Leukapheresis could be followed by further chemo-immunotherapy and then standard lymphodepletion (LD) with fludarabine-cyclophosphamide beforebrexucel infusion...Adverse events included cytokine release syndrome (CRS) in 8 (57%) pts (all grade 1); 3 pts neededsingle dose tocilizumab... From Dec 2024-July 31 2025, 28 pts have had leukapheresis,18 pts were infused and 14 pts with afollow-up (FU) >1 month post brexucel infusion were included in this report. The median age of theinfused pts was 35 years (range 19-77), and 5 pts (36%) were ³60 years of age. Ten pts (71%) receivedbrexcuel as FL consolidation therapy for adverse genomics, 3 FL pts (21%) had persistent (n=2)/recurrent(n=1) MRD, and 1 (7%) pt had R/R ALL."

Clinical • IO biomarker • P2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Inflammation • Leukemia • KMT2A • TP53

Phase 1 evaluation of the safety and efficacy of rapcabtagene autoleucel (YTB323) in adult patients with Relapsed/Refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) (ASH 2025) - P1/2 | "Sixteen pts (46%) were previously treated with blinatumomaband 13 pts (37%) with inotuzumab...CRS management includedtocilizumab (70%), siltuximab (10%), corticosteroids (40%), tocilizumab plus corticosteroids (37%), andanakinra (7%)...Seven pts received supportive measures for ICANS,including dexamethasone (5 pts, 71%) and anakinra (3 pts, 43%)... Phase 1 results with long follow-up suggest rapcabtagene autoleucel is active with highcellular expansion, durable efficacy for DL2–DL4, and a manageable safety profile in adult pts with r/r B-ALL. DL3—at which 92% of pts achieved BOR of CR/CRi by 3 mo, with median DOR not reached after 22mo median follow-up—exhibited an acceptable balance of safety, efficacy, and cellular expansion."

Clinical • P1 data • Acute Lymphocytic Leukemia • Aplastic Anemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Leukemia • Neutropenia • Rare Diseases

Humanized CD19 chimeric antigen receptor (CAR) T-cell therapy for high-risk and post-CAR relapse of B-cell acute lymphoblastic leukemia (ASH 2025) - P2 | "Patients received huCART19 at a dose of 5x106 CAR T cells/kg (maximum 2.5x108) afterlymphodepletion (LD) with fludarabine and cyclophosphamide...Prior therapy included HSCT in 21%, blinatumomab in 21% and inotuzumab in 15%.The CAR-naïve cohort (n=52) included 25 with first early BM relapse within 36m of diagnosis (12 25% blasts, 25/52 (48%) <0.01%...There was 1 death prior to day 28, due to gastrointestinal hemorrhageon day 2 in the setting of progressive ALL and Gr 2 CRS. CAR neurotoxicity was reported in 14/52 (27%, 2Gr 3, 2 Gr 4) CAR-naïve patients and 7/48 (15%, 1 Gr 3, 1 Gr 4) CAR-exposed, with 1 case of Gr 3 cerebraledema, fully recovered, and 1 case of ongoing myelopathy.ConclusionsHuCART19 produced durable remissions in high risk r/r B-ALL and demonstrated efficacy as salvagetherapy for those with poor response to prior CAR therapy, comparing favorably to historical outcomes inthis extremely high risk group."

Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia

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

International Study for Treatment of Childhood Relapsed Precursor B-Cell ALL 2020 (IntReALL BCP 2020) (clinicaltrials.gov) - P3 | N=750 | Not yet recruiting | Sponsor: Charite University, Berlin, Germany

New P3 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD22

Antibody-drug conjugates for the treatment of hematologic malignancies (AACR 2026) - "Belantamab mafodotin is composed of a monoclonal antibody targeting BCMA and is conjugated to the cytotoxic payload monomethyl auristatin F (MMAF), a microtubule disrupting agent, and is approved for multiple myeloma...Gemtuzumab oxogamicin targets the CD33 receptor on myeloid cells and is approved for AML...Inotuzumab ozogamicin targets the CD22 receptor on B-cell precursor leukemic cells and is approved for ALL in pediatric patients with R/R CD22-positive B-cell precursor ALL...Brentuximab vedotin is composed of a monoclonal antibody targeting the CD20 antigen and conjugated to microtubule disrupting agent monomethyl auristatin, which serves as the payload, for chronic Hodgkin's lymphoma...mPFS was 4.2 months (95% CI: 2.9, 7.1) with BV+R2 and 2.6 months (95% CI: 1.4, 3.1) with Pbo+R2 (HR 0.53, 95% CI: 0.38, 0.73). The ORR was 64.3% (95% CI: 54.7, 73.1) and 41.5% (95% CI: 32.5, 51.0), respectively."

ADC • Hematological Malignancies • Hodgkin Lymphoma • Leukemia • Lymphoma • Multiple Myeloma • Oncology • CD22 • CD33

Integrative multi-omic investigation of gene regulatory networks associated with chemotherapy response in acute lymphoblastic leukemia (AACR 2026) - "Common TF footprints that correlated with drug response included EBF family TFs for inotuzumab ozogamicin response and STAT family TFs for trametinib response. Subsequent multi-omic integration of gene expression, chromatin accessibility and TF footprinting with three-dimensional chromatin conformation maps identified over 9000 gene regulatory networks linked to altered drug response. Collectively, this work represents the largest study of chromatin accessibility and TF occupancy impacting ALL chemotherapy drug response and supports an important functional role for many DREs in anti-leukemic drug resistance."

Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology

Early Follow-up of the First Czech Real-world Data Analysis of Brexucabtagene Autoleucel in the Treatment of Acute Lymphoblastic Leukemia (EHA-EBMT-CART 2026) - "Background : Brexucabtagene autoleucel (brexu-cel) represents a major advancement in the treatment of adult patients with B-cell precursor acute lymphoblastic leukemia (B-ALL), following blinatumomab and inotuzumab ozogamicin. Compared with previously published data, we observed unexpectedly low toxicity and, despite the short follow-up, a trend toward improved survival. This may be related to the broader use of inotuzumab ozogamicin in bridging therapy – resulting in lower tumor burden prior to brexu-cel infusion – as well as to consistent prophylaxis and prompt management of early toxicity grades."

Clinical • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Infectious Disease • Leukemia • Septic Shock

High event-free (EFS) and overall survival (OS) after non-total body irradiation (TBI) conditioning and allogeneic hematopoietic cell transplantation (HCT) in next-generation-sequencing minimal residual disease (NGS-MRD) negative B-acute lymphoblastic leukemia (B-ALL): Results from the EndRAD trial (PTCTC ONC1701) (ASH 2025) - P2 | "Based upon retrospectivedata showing low rates of relapse, we hypothesized that patients with negative pre-HCT MRD by next-generation-sequencing of IgH B-cell receptor rearrangements (NGS-MRD) could achieve 2-year EFSexceeding 75% with a non-TBI regimen, an outcome comparable to those receiving TBI-based regimens. The Pediatric Transplantation and Cellular Therapy Consortium (PTCTC) conducted a phase IIprospective trial at 45 Centers in North America (ONC1701 EndRAD: NCT03509961) between 2018 and2025 to evaluate outcomes of myeloablative non-TBI conditioning regimens for allogeneic HCT in B-ALLpatients at lower risk for relapse defined by absence of NGS-MRD (Clonoseq) of B-cell receptorrearrangements (BCR) just prior to HCT...Mismatched related/haploidentical grafts received post-transplant cyclophosphamide orTCRαβ/CD19 depletion according to institutional preference...Of patientsenrolled, 33% were White/Non-Hispanic, 37% Hispanic, 12% Black or African American, and..."

Biomarker • Clinical • IO biomarker • Minimal residual disease • Next-generation sequencing • Residual disease • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • CNS Disorders • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Transplantation

Ph-Negative Acute Lymphoblastic Leukemia in the Older Adults: Biology, Therapeutic Strategies and Unmet Needs. (PubMed, Eur J Haematol) - "In this context, monoclonal antibodies such as blinatumomab and inotuzumab ozogamicin (InO), used alone or in combination with reduced-intensity chemotherapy, have emerged as promising frontline approaches capable of deep remissions with improved tolerability. Across all treatment strategies, comprehensive geriatric assessment appears more informative than performance status alone in predicting tolerability and outcome, supporting its integration into trial design and routine decision-making. Overall, the refinement of immunotherapeutic approaches, coupled with biologically and geriatrically tailored treatment algorithms, offers the most promising avenue to improve long-term outcomes for older patients with ALL."

IO biomarker • Journal • Review • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Pediatrics • TP53

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

SYSTEMIC EVALUATION FOR EXTRAMEDULLARY DISEASE AND TREATMENT OUTCOMES IN ADULT PATIENTS WITH RELAPSED/REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (EBMT 2026) - "Of them, 48 (52.7%) patients underwent allogeneic hematopoietic cell transplant (allo-HCT), 28 (30.8%) received antibodies blinatumomab/inotuzumab ozogamicin and 17 (18.7%) had a history of CAR-T therapy.For EMDs, 50 patients were assessed by PET/CT and 41 were assessed by CT/MRI/ultrasound. Among heavily treated adult patients with r/r B-ALL, 18F-FDG PET/CT identified a higher incidence of non-CNS EMD and hidden EMDs in MRD-positive patients, suggesting that PET/CT scan could be as a routine approach for EMD evaluation in r/r B-ALL. CAR-T followed by consolidation treatments improved long-term survival of patients with non-CNS EMD, providing a promising option for these patients with poor prognosis."

Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Central Nervous System Leukemia • Hematological Malignancies • Leukemia • CD22

INOTUZUMAB OZOGAMICIN AS A BRIDGE TO ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION IN RELAPSED/REFRACTORY B-ALL: A STUDY ON BEHALF OF GETH-TC (EBMT 2026) - "Defibrotide was used in all but one patient, with SOS resolution in 22 patients (67%). InO is an effective bridge to alloHCT for responsive R/R B-ALL patients. However, relapse and SOS remain major challenges, with InO exposure (>2 cycles or <50-day interval), number of prior treatment lines, and MRD status emerging as key risk factors influencing transplant outcomes."

Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Hepatology • Immunology • Infectious Disease • Transplantation

CAR-T PHENOTYPE AND HOST IMMUNE PROFILES AT APHERESIS AND POST-INFUSION DRIVE CD19 CAR-T PERSISTENCE IN PAEDIATRIC B ALL (EBMT 2026) - " Children receiving commercial tisagenlecleucel (Kymriah, Novartis) at the Royal Children's Hospital Melbourne between 2019–2024 were included...Stable NK cell frequencies from apheresis to Day 30 in early CAR-T persistence cases indicate a potential role for NK cells in supporting long-term CAR-T functionImpact of bridging therapy: Bridging with inotuzumab ozogamicin reshaped Day 30 immunity, increasing T cell levels while reducing NK cells, changes that may influence CAR-T–host crosstalk... This study highlights the critical role of pre-infusion immune fitness and early immune reconstitution in determining CD19 CAR-T persistence and outcome. Apheresis features, particularly CD4⁺ memory, NK, and MAIT cell abundance, alongside Day 30 immune profiles such as CAR-CD8⁺ differentiation state and endogenous T-cell recovery, are key determinants of durable response. Our findings support strategic timing of apheresis, tailored pre-apheresis/bridging therapies, and immune..."

CAR T-Cell Therapy • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Pediatrics • CD27 • CD4 • CD8

EFFICACY OF CNI-FREE GVHD PROPHYLAXIS IN PEDIATRIC PATIENTS UNDERGOING HAPLOIDENTICAL HEMATOPOIETIC STEM CELL TRANSPLANTATION AFTER PRIOR MONOCLONAL ANTIBODY THERAPY (EBMT 2026) - " This single-center retrospective cohort study enrolled 63 pediatric patients (<18 years) with ALL who received haploidentical HCT following prior treatment with inotuzumab ozogamicin and/or blinatumomab...The GVHD prophylaxis backbone for all patients consisted of post-transplant cyclophosphamide (PTCy) administered on days +3 and +4... Our findings suggest that CNI-free prophylactic regimens yield comparable survival outcomes and provide similar control over acute GVHD relative to standard CNI-based protocols. Future research should focus on elucidating the risk factors for chronic GVHD in this setting and developing targeted strategies to reduce its incidence."

Clinical • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Malignancies • Hepatology • Immunology • Leukemia • Pediatrics • Transplantation • Transplantation Associated Thrombotic Microangiopathy

THE ACHILLES HEEL OF KMT2A-REARRANGED ACUTE LYMPHOBLASTIC LEUKEMIA IN INFANTS (EBMT 2026) - "Depending on CD19 and/or CD22 expression, 28-days blinatumomab (blina) course (5mcg/15mkg/sq.m/day by IV continuous infusion) or inotuzumab ozogamicin (ino) 3 times once a week (0.8-0.5-0.5 mg/sq.m/1 hours IV infusion were applied prior to HSCT in all minimal residual disease positive (MRD(+)) cases (range 0.011-0.4% by flow cytometry). Although the combination of immunotherapy and HSCT together with chemotherapy for infant΄s KMT2A-r demonstrates promising results, treatment of pts with CNS positive KMT2A-r infants R/R ALL still a challenging problem. New CNS-directed curative strategy for this group of patients must be evaluated in the nearest future."

IO biomarker • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Transplant Rejection • AFF1 • CD22 • KMT2A • MLLT10 • MLLT3

NANOBODY-DERIVED CD19/CD22 TANDEM CAR-T THERAPY AS SALVAGE TREATMENT FOR IMMUNOTHERAPY-REFRACTORY B-ALL AFTER BLINATUMOMAB, INOTUZUMAB, OR PRIOR SINGLE-TARGET CAR-T: PHASE 1A DOSE FINDING AND RP2D EVALUATION (EBMT 2026) - P1/2 | "Nanobody-derived CD19/CD22 tandem CAR-T demonstrated promising efficacy and manageable toxicity as salvage therapy for immunotherapy-refractory B-ALL following prior immunotherapies."

CAR T-Cell Therapy • IO biomarker • P1 data • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • CD19 • CD22