NexCAR19 (talicabtagene autoleucel) / ImmunoACT, Cipla - LARVOL DELTA

Early Experience With Glofitamab Plus Polatuzumab Vedotin as Bridging Therapy Prior to CD19-Directed CAR T-Cell Therapy in Relapsed/Refractory Large B-Cell Lymphoma (SOHO 2026) - "Cycle 1: obinutuzumab (1000 mg) or rituximab (375 mg/m2) day 1, Pola (1.8 mg/kg) day 2, Glofit (2.5 mg) day 8 and (10 mg) day 15 in a 21-day cycle...After fludarabine-cyclophosphamide, a single Tali-cel infusion of ≥5 × 106 cells/kg was given... Glofit-Pola BT in R/R LBCL achieved high responses and enabled 93% to proceed to CAR-T therapy. Responses were largely maintained post Tali-cel. BT: bridging therapy, CAR-T: chimeric antigen receptor T-cell therapy, CI: confidence interval, CR: complete response, CRS: cytokine release syndrome, Glofit-Pola: glofitamab and polatuzumab vedotin, ICANS: immune effector cell–associated neurotoxicity syndrome, ICU: intensive care unit, LDH: lactate dehydrogenase, ORR: objective response rate, OS: overall survival, PD: progressive disease, PFS: progression-free survival, R/R LBCL: relapsed/refractory large B-cell lymphoma, SD: stable disease, Tali-cel: talicabtagene autoleucel."

CAR T-Cell Therapy • B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Efficacy of Inotuzumab Ozogamicin When Used as Salvage/Bridging Therapy Prior to CD19-Directed CAR-T Therapy in Relapsed/Refractory B-ALL: A Single-Center Experience (SOHO 2026) - "We evaluated the safety and efficacy of InO prior to talicabtagene autoleucel (Tali-cel)...Following fludarabine-cyclophosphamide conditioning, patients received either a single Tali-cel infusion of 5 × 106 or more CAR T cells/kg...Specifically, 15% received single-agent InO, while the remainder received combination therapy, most commonly mini-hyper-CVD (54.3%); ponatinib was the most common TKI used... InO achieved durable responses as salvage/bridging therapy in patients with R/R B-ALL, enabling 96% of patients to proceed to CAR-T therapy with acceptable toxicity profile. CAR-T: chimeric antigen receptor T-cell, CD: cluster of differentiation, CRS: cytokine release syndrome; CVD: cyclophosphamide, vincristine, dexamethasone; IEC-HS: immune effector cell-associated hemophagocytic lymphohistiocytosis-like syndrome; ICANS: immune effector cell-associated neurotoxicity syndrome; InO: inotuzumab ozogamicin; MRD: measurable residual disease; OS: overall survival; PFS:..."

CAR T-Cell Therapy • Clinical • IO biomarker • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD22

Efficacy of Talicabtagene Autoleucel in Relapsed/Refractory B-NHL in Complete Response at the Time of Infusion: A Single-Center Study (SOHO 2026) - "Cytokine release syndrome occurred in 68% (n = 13), with tocilizumab (42%) and anakinra (10%) used for management. Talicabtagene autoleucel consolidation is a highly effective strategy for aggressive relapsed/refractory B-NHL, with exceptional 1-year durability and safety profile, countering concerns that low antigen burden limits efficacy."

Clinical • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Real-World Utilization Trends and Access Disparities in CAR-T Therapy Across the Globe (SOHO 2026) - "By contrast, point-of-care manufacturing initiatives in India (talicabtagene autoleucel) reduced treatment costs to approximately $30000 and achieved a 70% to 89% overall response rate in real-world settings, with intensive care unit admission rates below 10%... Despite remarkable clinical efficacy, CAR-T use remains severely limited by racial, financial, and geographic inequities. Decentralized point-of-care manufacturing and targeted reimbursement policy interventions are urgently needed to broaden access and realize the therapy's full global public health potential. CD: cluster of differentiation, SEER: Surveillance, Epidemiology, and End Grant funding recognition: None."

CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Multiple Myeloma • Non-Hodgkin’s Lymphoma • Oncology

Global Disparities in Access to CAR-T Therapy for Hematologic Malignancies: Emerging Challenges in Equitable Cellular Therapy Delivery (SOHO 2026) - "Emerging real-world implementation programs in middle-income countries, including the development of indigenous CAR-T platforms (such as talicabtagene autoleucel [NexCAR19] in India), demonstrate potential pathways toward improving affordability and regional manufacturing capacity. Despite transforming outcomes in hematologic malignancies, CAR-T therapy remains inaccessible for large populations globally because of major economic, infrastructural, and regulatory disparities. Expanded regional manufacturing, streamlined regulatory pathways, innovative reimbursement strategies, and the development of decentralized treatment infrastructure are critical for achieving equitable global access to cellular therapies."

CAR T-Cell Therapy • Clinical • Hematological Malignancies • Leukemia • Lymphoma • Multiple Myeloma • Oncology

Impact of Loss of B-Cell Aplasia on Clinical Outcomes Following Talicabtagene Autoleucel in Patients With Relapsed/Refractory B-Cell Malignancies: A Single-Center Real-World Experience (SOHO 2026) - "LBCA following CAR T-cell therapy is associated with a significant risk of relapse. This highlights the need for routine B-cell monitoring and developing appropriate maintenance strategies. B-ALL: B-cell acute lymphoblastic leukemia, B-LBL: B-lymphoblastic lymphoma, CAR: chimeric antigen receptor, CD: cluster of differentiation, CR: complete remission, DLBCL: diffuse large B-cell lymphoma, HGNHL: high-grade non-Hodgkin lymphoma, LBCL: large B-cell lymphoma, MRD: minimal residual disease, OS: overall survival, PFS: progression-free survival."

Clinical • Clinical data • Real-world • Real-world evidence • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Large B Cell Lymphoma • Leukemia • Lymphoblastic Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Enabling access to talicabtagene autoleucel in relapsed/refractory B-cell malignancies; multicenter real-world evidence on delivery, efficacy and safety. (PubMed, Blood Cancer J) - "Grade 3/4 cytokine release syndrome (CRS), immune effector cell-associated neurotoxicity syndrome (ICANS), and Immune Effector Cell-associated Hemophagocytic Lymphohistiocytosis-like Syndrome (IEC-HS) occurred in 6%, 4%, and 23% of r/r B-ALL and 6%, 3%, and 18% of r/r B-NHL patients, respectively. These findings demonstrate the successful implementation of tali-cel across multiple centers in a large cohort, which might contribute towards improving CAR-T access globally."

HEOR • Journal • Real-world evidence • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rare Diseases • Transplantation

EARLY EXPERIENCE WITH GLOFITAMAB PLUS POLATUZUMAB VEDOTIN AS BRIDGING THERAPY PRIOR TO CD19-DIRECTED CAR T-CELL THERAPY IN R/R B-CELL LYMPHOMA (EHA 2026) - "We evaluated the safety and efficacy of this combination as BT prior to talicabtagene autoleucel (Tali-cel) in patients (pts) with r/r BCL...During cycle 1, patients received obinutuzumab (1000 mg) or rituximab (375 mg/m²) on day 1, pola (1.8 mg/kg) on day 2, and glofit on days 8 (2.5 mg) and 15 (10 mg) of a 21-day cycle...All CRS events were managed with tocilizumab...93% were successfully bridged to CAR T- cell therapy and responses achieved post-BT were mostly maintained following Tali-cel infusion. Swimmer plot showing longitudinal responses after Glofit-Pola and Tali-cel"

CAR T-Cell Therapy • B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma

FRONTLINE CD19-DIRECTED CAR T-CELL THERAPY AS CONSOLIDATION IN HIGH-RISK B-ALL: A REAL-WORLD SINGLE-CENTER EXPERIENCE (EHA 2026) - "In settings without access to blinatumomab and with low transplant rates, CD19-directed CAR T-cell therapy may serve as a potential consolidation option. Aims To evaluate the safety and efficacy of Talicabtagene autoleucel (Tali-cel) as consolidation in high-risk B-ALL...All pts received conventional chemotherapy for induction, only 1 received inotuzumab during phase 2 induction...Tocilizumab was administered in 17 pts (90%) who developed CRS, with a median dose of 1 (range 1–3); vasopressors were required in 2 pts. IEC-HS was observed in 9 (31%), all of whom received anakinra, and 4 also received ruxolitinib...Although longer follow-up is warranted, our findings support the need for prospective evaluation of CAR T-cell therapy as consolidation in this setting. Kaplan-Meier curves showing event-free survival and overall survival"

CAR T-Cell Therapy • Clinical • IO biomarker • Real-world • Real-world evidence • Infectious Disease • Septic Shock • ABL1 • IKZF1 • PBX1 • TCF3 • TP53 • ZNF384

NexCAR19 (Talikabtagene Autoleucel) in Relapsed/Refractory B-Cell Malignancies (NexCAR19) (clinicaltrials.gov) - P2/3 | N=40 | Recruiting | Sponsor: Health Institutes of Turkey

New P2/3 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Indolent Lymphoma • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CCND1 • CD19

A Novel CAR-T Cell Therapy Product (Talicabtagene Autoleucel: Tali-cel) Shows Promising Activity in Relapsed/ Refractory B-acute Lymphoblastic-leukemia (R/R B-ALL) Patients: Phase Ib/II Clinical Trial (EHA-EBMT-CART 2026) - "Clinical Trial Registry : Reg no. CTRI/2023/03/050689"

CAR T-Cell Therapy • Clinical • IO biomarker • P1/2 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Leukemia • CD19

An Indigenous CAR-T Journey: Managing IEC-HS and Tracking Response Using a Homegrown CTDNA Assay (EHA-EBMT-CART 2026) - "Background : Indigenous CAR-T therapies such as Actalycabtagene autoleucel (Actalyc-CAR-T) represent a major advance in India’s heme-onc landscape...CRS occurred in 41.7% (5/12), including 16.7% (2/12) with grade ≥3 events; all resolved with tocilizumab. IEC-HS/HLH developed in 25% (3/12), typically around day +21, and responded promptly to corticosteroids and anakinra with complete resolution within 10 days...Extending this to a six-patient series showed early ctDNA decline accompanying CMR, sustained suppression in durable responders, and ctDNA re-emergence preceding or contrasting with PET findings, aligning with global observations of early molecular relapse detection [4,5].These findings highlight how a homegrown ctDNA platform, combined with Actalyc-CAR-T, has enabled biologically informed and fully indigenous CAR-T care in Indian practice. Larger prospective cohorts are needed to refine ctDNA-guided monitoring and early-intervention strategies."

Circulating tumor DNA • Bone Marrow Transplantation • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Metabolic Disorders

In-vivo Dynamics of a Novel CD19-directed CAR-T Cell Therapy in Paediatric and Young Adults with Relapsed/Refractory B-acute Lymphoblastic Leukemia (R/R B-ALL) (EHA-EBMT-CART 2026) - "We explored in-vivo dynamics of novel CD19-directed CAR-T product Tali-cel (Nexcar19) post-infusion in patients with relapse/refractory(r/r) B-ALL...Clinical Trial Registry : Reg no. CTRI/2023/03/050689"

CAR T-Cell Therapy • IO biomarker • Preclinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Inflammation • Leukemia • Pediatrics • CD4 • CD8 • CXCL8 • IL10 • IL6

NPPA asks cos to revise prices of 17 drugs following BCD exemption (Pharmabiz) - "The list of drugs include ribociclib, abemaciclib, actalycabtagene autoleucel, tremelimumab, venetoclax, ceritinib, brigatinib..."

Commercial • B Acute Lymphoblastic Leukemia • B Cell Lymphoma • Chronic Lymphocytic Leukemia • HER2 Negative Breast Cancer • Hormone Receptor Positive Breast Cancer • Non Small Cell Lung Cancer • Small Lymphocytic Lymphoma

Cipla Ltd has entered into a strategic partnership with ImmunoACT on January 20 to launch talicabtagene autoleucel, an anti-CD19 CAR-T cell therapy, for the treatment of blood cancers across select African markets. (Scanx) - "Under the exclusive licensing and supply agreement, Cipla will commercialise the therapy through its subsidiary Medpro Pharmaceutica in three key African markets....Separately, Cipla faces regulatory scrutiny as the US Food and Drug Administration (USFDA) has made multiple observations at one of its facilities. The regulatory concerns include: Procedures to prevent contamination were not followed; Control systems designed to prevent contamination were deficient; Deficiencies in aseptic processing areas and laboratory controls; Failure to establish procedures to assure drug purity and quality; Inconsistent following of sampling plans and test procedures; Buildings used in manufacturing not maintained in good state."

FDA event • Licensing / partnership • B Acute Lymphoblastic Leukemia • Non-Hodgkin’s Lymphoma

Early post-infusion cytokine profiling predicts toxicity and outcomes in recipients of NexCAR19 (Actalycabtagene Autoleucel): A pilot study with point-of-care assay integration (ASH 2025) - "While cytokine kinetics have been well-characterized incommercial CAR-T products such as tisagenlecleucel and axicabtagene ciloleucel, no published studies todate have described cytokine profiles in recipients of NexCAR19 (Actalycabtagene autoleucel), a novelCD19-directed CAR-T cell product developed in India. Early post-infusion cytokine profiling in NexCAR19 recipients demonstrated predictive utility for keytoxicities and adverse clinical outcomes. Elevated IL-1β, IL-2, IL-6, and MCP-1 levels were significantlyassociated with HLH, cytopenias, infections, and mortality. The rapid turnaround of the point-of-carecytokine panel supports its feasibility in real-time clinical decision-making."

Clinical • IO biomarker • Acute Lymphocytic Leukemia • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Septic Shock • Thrombocytopenia • IFNG • IL1B • IL2 • IL6 • TNFA

Tali-cel is a safe and effective therapy in patients with Relapsed/Refractory B-cell non-Hodgkin lymphoma that allows equitable access- a real-world experience from India. (ASH 2025) - "Background : Talicabtagene autoleucel (Tali-cel), a second-generation, humanized CAR-T cell therapytargeting CD19, was approved in India in October 2023 for the treatment of relapsed or refractory (r/r) B-cell malignancies...Mostpatients had received a median of 2 prior treatment lines (range: 1–7), including polatuzumab (14%), andstem cell transplantation (4%)...Tocilizumab was administered in 63%patients who developed CRS with median dose of 1 (range 1-3)...IVIG support was required in 34% patients and anakinra formanagement of IEC-HS was required 75% respectively...This real-world analysis demonstrates that tali-cel is a practical, effective, and well-tolerated treatmentoption for r/r B-NHL in India. As the first large-scale, multicenter evaluation of this therapy in the Indianhealthcare landscape, our findings support its broader implementation across various levels of clinicalpractice."

Clinical • Real-world • Real-world evidence • B Cell Non-Hodgkin Lymphoma • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Lymphoma • Non-Hodgkin’s Lymphoma

Early use of talicabtagene autoleucel in r/r B-acute lymphoblastic leukemia is cost-effective: Improved efficacy, reduced toxicity and healthcare resource utilization support affordable access (ASH 2025) - "Utilization of tocilizumab(72% vs. 62%), anakinra (26% vs. 24%), and IVIG (49% vs. 54%) was similar between groups, reflectingconsistent supportive management.Cost modelling revealed a 60% reduction in median hospitalization costs for early-relapse patients, drivenby shorter hospital stay, less ICU need, and fewer high-grade toxicities requiring intensive management.In this real-world cohort, patients with early relapse r/r B-ALL treated with tali-cel achieved more durableresponses, with higher remission rates and longer progression-free survival compared to those treatedlater in the disease course. In this real-world cohort, patients with early relapse r/r B-ALL treated with tali-cel achieved more durableresponses, with higher remission rates and longer progression-free survival compared to those treatedlater in the disease course. Importantly, early use was associated with lower toxicity, reduced healthcareresource utilization, and a significant reduction in overall..."

Clinical • Cost effectiveness • HEOR • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Leukemia

Advancing CAR-T Cell Manufacturing in Latin America: Current Landscape, Future Directions, and Challenges. (PubMed, Crit Rev Oncol Hematol) - "India's talicabtagene autoleucel program built domestic vector and cell production to lower cost and shorten timelines, Brazil coupled a mature regulatory pathway with accredited centers and an emerging national platform for vectors and plasmids, Mexico demonstrated feasibility of hospital based closed system production under national oversight; Colombia and Chile are developing academic pipelines and locally relevant targets...Finally, coordinated alliances among hospitals, professional societies, patient groups, academia, and industry are needed to secure policy support and public investment. Together, these measures provide with a realistic path to safe, equitable, and affordable access to CAR T therapy in Latin America."

Journal • Review • Hematological Disorders • Hematological Malignancies • Oncology

CD 19 CAR T-Cell Therapy in R/R B Cell Malignancies : A Real World Experience from CAR T Working Group, Delhi Ncr ,India (ASH 2024) - "Indigenously developed humanized CD-19 CAR T-cell therapy ( Actalycabtagene Autoleucel , NexCAR-19, ImmunoACT) has become available very recently in India.We report here our early real world experience, of CAR T-cell therapy in RR DLBCL and RR B-ALL from 3 major cancer centres in northern India (Delhi-NCR CAR T working group).15 patients were treated DLBCL -12 , B-ALL -3 from January 2023 to June 2024...The median baseline IgG level was 779 mg/dl (475-1247) and median trough level post CAR T-cell infusion was 566 mg/dl (319-972).11/15 patients received debulking treatment ( Acalabrutinib -Lenalidomide in 3 , Polatuzumab based in 4, R-GEMOX in 2 , Venetoclax -Lenalidomide in 1 , orbital RT in 1 ALL with an orbital lymphomatous mass) while 8/15 received bridging therapy (VIPOR in 1, Gemcitabine -Cyclophosphamide in 1, GEMOX in 1 , Acalabrutinib Lenalidomide in 2, Pola-BR in 1, Procarbazine, Cyclophosphamide, Etoposide, Prednisone + Ara-c in 1 B-ALL) .CRS was seen in 10..."

CAR T-Cell Therapy • Clinical • Real-world • Real-world evidence • CNS Disorders • CNS Lymphoma • Diffuse Large B Cell Lymphoma • Fibrosis • Hematological Malignancies • Hepatology • Immunology • Infectious Disease • Liver Cirrhosis • Lymphoma • Oncology • Pneumonia • Respiratory Diseases • Secondary Central Nervous System Lymphoma • TP53

Evaluating the Safety of HCAR19 (Now Actalycabtagene Autoleucel- Actaly-Cel™), a Novel Humanized CD19-Directed Chimeric Antigen Receptor T-Cells in Pediatric, Adolescents, and Young Adults with Relapsed/ Refractory B- Acute Lymphoblastic Leukemia (ESHA) - Report of Phase-1B (ASH 2023) - "Lymphodepletion was with Fludarabine (30mg/m 2) x 3-days and cyclophosphamide (500 mg/m 2) x 2-days...Those with ≥ Grade-2 CRS received tocilizumab with full recovery...In-vivo dynamics and toxicity profile of Actaly-cel showed robust activity and low cytokines corroborating with pre-clinical studies. A median dose of 5x10 6/kg Actaly-cel is proposed as the P2D."

CAR T-Cell Therapy • Clinical • P1 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Genetic Disorders • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Leukopenia • Novel Coronavirus Disease • Obesity • Oncology • Pediatrics • Thrombocytopenia • IFNG • IL6

High Efficacy and Excellent Safety Profile of Actalycabtagene Autoleucel, a Humanized CD19 CAR-T Product in r/r B-Cell Malignancies: A Phase II Pivotal Trial (ASH 2023) - "Patients received infusion of Actaly-cel two days after conditioning with fludarabine plus cyclophosphamide...Only 1(3%) patient required ICU admission, 2(6%) required vasopressor support, tocilizumab was administered to 18 (55%) patients, median 1 dose (1-4) and steroids were used in 5 (15%) cases... Actaly-cel demonstrated efficacy in r/r B-cell malignancies with a very favorable safety profile. The absence of ICANS, shorter duration of cytopenias and a lower incidence of grade 3/4 CRS makes it one of the safest CD19 CAR-T cell therapy products. Actaly-cel can improve the ease of delivery of CAR T-cell therapy in a wide-range of settings."

Clinical • P2 data • Acute Lymphocytic Leukemia • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Disorders • Hematological Malignancies • Indolent Lymphoma • Leukemia • Lymphoma • Neutropenia • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • Thrombocytopenia

Excellent Safety Profile of a Low-Cost Novel Humanized CD19 CAR T-Cell Therapy, Actalycabtagene Autoleucel : Potential Impact on Access and Feasibility (ASH 2023) - "After lymphodepletion (LD) with a fludarabine plus cyclophosphamide (FC) regimen for 3 days, patients received Actaly-cel at a target dose ≥ 5 million CAR-T cells/kg (upper limit; total 2 x109)...A single dose of tocilizumab was given to 36% (10/28) of patients and only 4% (1/28) received tocilizumab plus corticosteroids... Actaly-cel was efficacious, with no incidence of ICANS and manageable CRS across a wide dose range. More importantly, this study reported low HCRUs due to negligible ICU admission and shorter duration of hospitalization, ensuring potential usage of Actaly-cel in outpatient settings, and ultimately improving the access and feasibility of CD19 CAR-T cell therapy in resource constrained settings such as LMICs."

CAR T-Cell Therapy • Clinical • Hematological Malignancies • Lymphoma • Oncology

Establishing a CAR-T Cell Therapy Centre in a Resource Limited Setting: Barriers and Early Outcomes (ASH 2024) - "In October 2023, India's Central Drugs Standard Control Organization approved Acalycabtagene Autoleucel (NexCAR19) to treat relapsed or refractory B-cell leukaemia (B-ALL) and lymphoma...Seven (87.5%) patients received fludarabine plus cyclophosphamide, while one (0.12%) received bendamustine...Five (62.5%) patients paid out of pocket, supported by crowdfunding campaigns from our public education initiatives, while three (37.5%) were covered by insurance or reimbursement.Conclusions : Despite challenges such as high CAR-T costs, resource constraints, and patient affordability, the therapy was effectively implemented in an LMIC setting. Limitations included early-stage data, small sample sizes, and brief follow-up, yet the results highlight its potential for effective use in similar resource-constrained environments."

CAR T-Cell Therapy • B Cell Lymphoma • Hematological Malignancies • Hemophagocytic lymphohistiocytosis • Immunology • Infectious Disease • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Rare Diseases • Septic Shock

Talicabtagene Autoleucel (humanized CD19 CAR-T) As a Second Line Therapy in r/r B-Cell Lymphoma: Sub-Analysis from a Phase I/II Trial (ASH 2024) - "The requirement for tocilizumab and corticosteroids (cohort 1 : 10% vs cohort 2 : 6%) was comparable, whereas the transfusion support (cohort 1 : 30% vs cohort 2 : 44 %) and IVIG treatment (cohort 1 : 40% vs cohort 2 : 53%) was lower in the patients in cohort 1.The patients in cohort 1 showed higher peak expansion on Day 14 (median, cohort 1 : 2.56x105 vs cohort 2 : 0.57x105 copies/μg of DNA) and the levels further persisted until last follow-up. The CAR-T cell products from cohort 1 had a higher percentage of CD8+ naïve cells in apheresis as well as CAR-T cell product, which associated with robust CAR-T expansion and durable response.Conclusion : In this post-hoc analysis,Tali-cel was found to be more well-tolerated, more efficacious, and easier to deliver in the second line setting for r/r DLBCL. Given limited patients in each cohort, further study based on post-marketing surveillance is planned."

Clinical • P1/2 data • B Cell Lymphoma • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD8