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14 Diseases | | 27 Products |
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39 Trials |  |
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- Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
REAL-WORLD EXPERIENCE OF CAR T-CELL THERAPY: A SINGLE CENTRE EXPERIENCE (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_2394;
CAR-T therapy provides an answer for some, with acceptable toxicity. Our real-world data shows that over the years, with broader selection criteria, inclusion of older patients, and those with higher disease burden, worse outcomes are observed.
- Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
PHYSICAL AND PSYCHOLOGICAL NEEDS AFTER CAR-T THERAPY: TWO NURSES (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_2263;
In the care of patients who receive CAR-T cell therapies, nurses should ideally be competent in general nursing skills (patient-centered care, clinical assessment, tracheostomy care, etc.), but also be trained in CRS and ICANS monitoring as well as have clear guidance on how to advocate for their patients in the critical situations as described above. Additionally, nurses should be trained in intercultural competencies and recognize the added complexity of their patients
- Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
OUTCOMES OF COMMERCIAL AND IN-HOUSE ANTI CD19 CAR T-CELL THERAPY FOR RELAPSED/REFRACTORY B-CELL LYMPHOMA IN SINGAPORE (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_2176;
The real-world efficacy of Kymriah in our patients were equivalent to trial and other real-world reports. Local manufacture enables access of high-risk patients with aBCL to CAR T-products despite financial constraints and rapidly progressing disease
- NURSES ROLE IN CAR-T ADVERSE EFFECTS MANAGEMENT - SINGLE CENTER EXPERIENCE (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_2098;
One of the most severe AEs are CRS and ICANS. Nurses play a crucial role in CAR-T patients care.
- Kymriah (tisagenlecleucel-T) / Novartis, Tecartus (brexucabtagene autoleucel) / Gilead, Yescarta (axicabtagene ciloleucel) / Gilead
IMPACT OF EARLY CAR (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1766;
Among possible determinants of CD4+ T cell recovery, we recognized infusion of a 4-1BB product (tisagenlecleucel, TSA) in comparison with CD28-based ones (axicabtagene/brexucabtagene, AXI/BRX) (hazard ratio [95% CI]: 5.79 [1.16-24.12] p = 0.016). We conclude that a faster CAR
- Kymriah (tisagenlecleucel-T) / Novartis, Tecartus (brexucabtagene autoleucel) / Gilead, Yescarta (axicabtagene ciloleucel) / Gilead
IMPACT OF EARLY CAR (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1765;
Among possible determinants of CD4+ T cell recovery, we recognized infusion of a 4-1BB product (tisagenlecleucel, TSA) in comparison with CD28-based ones (axicabtagene/brexucabtagene, AXI/BRX) (hazard ratio [95% CI]: 5.79 [1.16-24.12] p = 0.016). We conclude that a faster CAR
- HEMATOTOXICITY POST CAR-T CELL THERAPY: REAL-WORLD DATA ON RISK FACTORS AND OUTCOMES (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1678;
IACHT does not predispose to infection or disease response. Additional studies are needed to elucidate the pathophysiology of cytopenia and facilitate early interventions to improve outcomes in these patients.
- HEMATOTOXICITY POST CAR-T CELL THERAPY: REAL-WORLD DATA ON RISK FACTORS AND OUTCOMES (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1677;
IACHT does not predispose to infection or disease response. Additional studies are needed to elucidate the pathophysiology of cytopenia and facilitate early interventions to improve outcomes in these patients.
- Kymriah (tisagenlecleucel-T) / Novartis
EXCELLENT OUTCOME OF CAR-T CELL THERAPY IN CHILDREN WITH PB-ALL RELAPSING POST HSCT, WHO HAD VERY LOW MRD AT LYMPHODEPLETING CHEMOTHERAPY (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1493;
CAR-T cell therapy increases the chance for cure in high-risk patients, in whom HSCT had not guaranteed long-lasting remission. To enhance the probability of optimal outcome, the goal should be to obtain as low disease burden before LDC as possible, ideally with negative MRD.
- Kymriah (tisagenlecleucel-T) / Novartis
EXCELLENT OUTCOME OF CAR-T CELL THERAPY IN CHILDREN WITH PB-ALL RELAPSING POST HSCT, WHO HAD VERY LOW MRD AT LYMPHODEPLETING CHEMOTHERAPY (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1492;
CAR-T cell therapy increases the chance for cure in high-risk patients, in whom HSCT had not guaranteed long-lasting remission. To enhance the probability of optimal outcome, the goal should be to obtain as low disease burden before LDC as possible, ideally with negative MRD.
- Kymriah (tisagenlecleucel-T) / Novartis, Tecartus (brexucabtagene autoleucel) / Gilead, Yescarta (axicabtagene ciloleucel) / Gilead
EVALUATING COGNITIVE IMPAIRMENT AND NEUROTOXICITY POST CAR T CELL THERAPY (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1468;
Our preliminary data suggest that cognitive assessment is feasible in CAR-T cell therapy recipients. The lowest score was found at time T1, suggesting that cognitive dysfunction might be linked to acute toxicities observed in these patients.
- Kymriah (tisagenlecleucel-T) / Novartis, Tecartus (brexucabtagene autoleucel) / Gilead, Yescarta (axicabtagene ciloleucel) / Gilead
EVALUATING COGNITIVE IMPAIRMENT AND NEUROTOXICITY POST CAR T CELL THERAPY (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1467;
Our preliminary data suggest that cognitive assessment is feasible in CAR-T cell therapy recipients. The lowest score was found at time T1, suggesting that cognitive dysfunction might be linked to acute toxicities observed in these patients.
- Kymriah (tisagenlecleucel-T) / Novartis, Tecartus (brexucabtagene autoleucel) / Gilead, Yescarta (axicabtagene ciloleucel) / Gilead
EVALUATING COGNITIVE IMPAIRMENT AND NEUROTOXICITY POST CAR T CELL THERAPY (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1466;
Our preliminary data suggest that cognitive assessment is feasible in CAR-T cell therapy recipients. The lowest score was found at time T1, suggesting that cognitive dysfunction might be linked to acute toxicities observed in these patients.
- Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
ELEVATED MYELOID-DERIVED SUPPRESSOR CELL (MDSC) LEVELS RESULT IN REDUCED CAR-T CELL EXPANSION AND IMPAIRED EFFICACY (Hall 3 South) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1427;
A total of 45 patients diagnosed with DLBCL (30), MCL (9), PMBL (3), or B-ALL (3) and treated with tisa-cel, axi-cel, or brexu-cel were analyzed. The immunological environment at the infusion of CAR-T cells significantly influences their expansion and antineoplastic efficacy.The high circulating levels of G-MDSC may represent a promising predictive biomarker and possibly a hypothetical point of intervention for ameliorating CAR-T efficacy.
- EFFICACY OF SALVAGE THERAPY INCLUDING NOVEL AGENTS IN ADULT B-CELL ACUTE LYMPHOBLASTIC LEUKAEMIA (B-ALL) PROGRESSING AFTER ALLOGENEIC STEM CELL TRANSPLANTATION: A REAL-WORLD UK STUDY (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1425;
The efficacy of 2nd allo-SCT is limited, unless utilized as post-CAR-T consolidation. DLI emerges as a potentially beneficial intervention and its impact should be explored in other datasets to confirm this finding.
- EFFICACY OF SALVAGE THERAPY INCLUDING NOVEL AGENTS IN ADULT B-CELL ACUTE LYMPHOBLASTIC LEUKAEMIA (B-ALL) PROGRESSING AFTER ALLOGENEIC STEM CELL TRANSPLANTATION: A REAL-WORLD UK STUDY (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1424;
The efficacy of 2nd allo-SCT is limited, unless utilized as post-CAR-T consolidation. DLI emerges as a potentially beneficial intervention and its impact should be explored in other datasets to confirm this finding.
- Kymriah (tisagenlecleucel-T) / Novartis
EFFECTIVE TREATMENT OF POST-TRANSPLANT RELAPSE IN YOUNG PATIENTS WITH ALL: POST APPROVAL REAL WORLD EXPERIENCE OF TREATMENT WITH TISAGENLECLEUCEL (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1380;
DLI emerges as a potentially beneficial intervention and its impact should be explored in other datasets to confirm this finding. A) EFS and OS for all patients (24-months estimate
- Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
EASIX SCORE AS A PROGNOSTIC FACTOR OF CYTOKINE RELEASE SYNDROME IN CAR-T PATIENTS - A RETROSPECTIVE ANALYSIS OF MM AND LBCL COHORTS (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1365;
3 in the LBCL CAR-T cohort. On the contrary, these scores seem to have no value in the prediction of CRS in MM/amyloidosis CAR-T patients.
- Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
EASIX SCORE AS A PROGNOSTIC FACTOR OF CYTOKINE RELEASE SYNDROME IN CAR-T PATIENTS - A RETROSPECTIVE ANALYSIS OF MM AND LBCL COHORTS (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1364;
3 in the LBCL CAR-T cohort. On the contrary, these scores seem to have no value in the prediction of CRS in MM/amyloidosis CAR-T patients.
- fludarabine IV / Generic mfg., cyclophosphamide / Generic mfg.
DOSE MODIFICATIONS OF FLUDARABINE AS PART OF FLUDARABINE AND CYCLOPHOSPHAMIDE (FC) LYMPHODEPLETION IN PATIENTS WITH RENAL IMPAIRMENT RECEIVING LICENSED CAR-T CELL THERAPIES IN THE UK (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1345;
On the contrary, these scores seem to have no value in the prediction of CRS in MM/amyloidosis CAR-T patients. Clinical Trial Registry: N/A Background: The recommended lymphodepletion regimens for the three chimeric antigen receptor T-cell (CAR-T) therapies licensed in the UK (Yescarta
- DEVELOPMENT OF DISEASE-SPECIFIC COMPOSITE END-POINTS OF TOXICITY-FREE, PROGRESSION-FREE SURVIVAL (TPFS) AFTER CHIMERIC ANTIGEN RECEPTOR T-CELL THERAPY FOR PATIENTS WITH LARGE B-CELL LYMPHOMA AND MULTIPLE MYELOMA (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1305;
TPFS6 in LBCL and TPFS3 in MM predicted long term OS. Thus, disease-specific TPFS may serve as an ideal composite safety and efficacy endpoint in future CAR T trials aiming at improving efficacy and mitigating toxicities.
- DEVELOPMENT OF DISEASE-SPECIFIC COMPOSITE END-POINTS OF TOXICITY-FREE, PROGRESSION-FREE SURVIVAL (TPFS) AFTER CHIMERIC ANTIGEN RECEPTOR T-CELL THERAPY FOR PATIENTS WITH LARGE B-CELL LYMPHOMA AND MULTIPLE MYELOMA (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1304;
TPFS6 in LBCL and TPFS3 in MM predicted long term OS. Thus, disease-specific TPFS may serve as an ideal composite safety and efficacy endpoint in future CAR T trials aiming at improving efficacy and mitigating toxicities.
- Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
DAY7-CART COUNT ENHANCES PREDICTIVE POWER OF PET30 AND POSSIBLY ANTICIPATES CD19 LOSS IN RELAPSE AFTER CART (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1276;
In this small, retrospective cohort, PET30 and Day7-CAR-T-count greatly support each other in predicting lasting remission vs. relapse. In addition, relapse after high-CAR peak was associated with CD19 loss in 4 of 7 cases, whereas relapse after low CAR-peak was not possibly suggesting distinct resistance mechanisms
- Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
DAY7-CART COUNT ENHANCES PREDICTIVE POWER OF PET30 AND POSSIBLY ANTICIPATES CD19 LOSS IN RELAPSE AFTER CART (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1275;
In this small, retrospective cohort, PET30 and Day7-CAR-T-count greatly support each other in predicting lasting remission vs. relapse. In addition, relapse after high-CAR peak was associated with CD19 loss in 4 of 7 cases, whereas relapse after low CAR-peak was not possibly suggesting distinct resistance mechanisms
- Kymriah (tisagenlecleucel-T) / Novartis, Tecartus (brexucabtagene autoleucel) / Gilead, Yescarta (axicabtagene ciloleucel) / Gilead
CORRELATION OF IL-6 LEVELS WITH THE EXPANSION OF LYMPHOCYTIC POPULATIONS, SEVERITY OF CYTOKINE RELEASE SYNDROME AND NEUROTOXICITY FOLLOWING CAR-T CELL THERAPY (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1236;
This study suggests the potential use of IL-6 levels as a biomarker for CRS but not for ICANS. The application of IL-6 measurement is an easy, fast and effective method that can contribute to the selection of patients for early interventions aimed at preventing complications of CAR-T therapy.
- Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
CHOICE OF COMMERCIALLY AVAILABLE CAR T-CELLS PRODUCT FOR AGGRESSIVE LYMPHOMA: A SURVEY OF BEHALF OF THE CELLULAR THERAPY & IMMUNOBIOLOGY WORKING PARTY (CTIWP) OF THE EBMT (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_1121;
The majority of centers have access to more than one CAR-T cells, mostly tisa-cel and axi-cel. While there were no main differences between the 2 products regarding access and cost, the majority of centers consider axi-cel to be more effective, while tisa-cel is considered to have a better safety profile, making axicel the preferred product in young patients with aggressive diseases, and tisa-cel in elderly patients.
- Opdivo (nivolumab) / Ono Pharma, BMS
ADDITION OF NIVOLUMAB TAILORED BY EXPANSION OF CAR-T CELLS IN PATIENTS WITH PROGRESSIVE DLBCL AT LYMPHODEPLETION (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_874;
P2
Addition of nivolumab tailored by expansion of CAR-T cells in patients with PD at LD is safe and is associated with impressive early response rate. Durability of response is however, suboptimal and future trials addressing this challenge may further improve results
- Kymriah (tisagenlecleucel-T) / Novartis, Actemra IV (tocilizumab) / Roche, JW Pharma, Yescarta (axicabtagene ciloleucel) / Gilead
ACUTE INFECTION AND BASELINE C-REACTIVE PROTEIN (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_863;
This study provides evidence for an unexpected association between this ACPI28 and risk of early lymphoma progression. We speculate that this could be due to poor CAR-T expansion due to adverse cytokine profile precipitated by the immune response to severe infection.
- Kymriah (tisagenlecleucel-T) / Novartis, Actemra IV (tocilizumab) / Roche, JW Pharma, Yescarta (axicabtagene ciloleucel) / Gilead
ACUTE INFECTION AND BASELINE C-REACTIVE PROTEIN (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_862;
This study provides evidence for an unexpected association between this ACPI28 and risk of early lymphoma progression. We speculate that this could be due to poor CAR-T expansion due to adverse cytokine profile precipitated by the immune response to severe infection.
- Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
A SIMPLE PREDICTIVE ALGORITHM FOR ESTIMATION OF THE BLOOD VOLUME TO BE PROCESSED TO YIELD TARGET CELL NUMBERS FOR MANUFACTURING OF TISA-CEL (CLYDE) - Feb 14, 2024 - Abstract #EBMT2024EBMT_852;
Nevertheless, our algorithm facilitates the daily routine of the operators by generating clear guidance on the calculable duration of the leukapheresis. When CE2 changes over time, the algorithm can easily be adjusted by exchanging the corrected CE2 value in the formulas.
- Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
A SIMPLE PREDICTIVE ALGORITHM FOR ESTIMATION OF THE BLOOD VOLUME TO BE PROCESSED TO YIELD TARGET CELL NUMBERS FOR MANUFACTURING OF TISA-CEL (ePoster area) - Feb 14, 2024 - Abstract #EBMT2024EBMT_851;
Nevertheless, our algorithm facilitates the daily routine of the operators by generating clear guidance on the calculable duration of the leukapheresis. When CE2 changes over time, the algorithm can easily be adjusted by exchanging the corrected CE2 value in the formulas.
- | Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost-effectiveness of axicabtagene ciloleucel versus tisagenlecleucel for the treatment of 3L?+?relapsed/refractory large B-cell lymphoma in the United States: incorporating longer survival results. (Pubmed Central) - Feb 14, 2024
Axi-cel remained cost-effective versus tisa-cel (assuming a willingness-to-pay threshold of $150,000 per QALY) across a range of scenarios. With longer-term survival data, axi-cel continues to represent a cost-effective option versus tisa-cel for treatment of r/r LBCL among patients who have previously received ?2 lines of systemic therapy, from a US payer perspective.
- | Kymriah (tisagenlecleucel-T) / Novartis
Journal, CAR T-Cell Therapy: Brief research report: in-depth immunophenotyping reveals stability of CD19 CAR T-cells over time. (Pubmed Central) - Feb 10, 2024
We conducted a prospective observational study of 12 patients treated with Tisagenlecleucel for CD19+ B-cell malignancies...Unsupervised cluster analysis revealed an immune signature of CAR T-cell products associated with the development of immune cell-associated neurotoxicity syndrome. Warranting validation in an independent patient cohort, in-depth phenotyping of CAR T-cell products as well as longitudinal monitoring post cell transfer might become a valuable tool to increase efficacy and safety of CAR T-cell therapy.
- | Kymriah (tisagenlecleucel-T) / Novartis
Retrospective data, Journal, CAR T-Cell Therapy, IO biomarker: Impact of disease burden and late loss of B cell aplasia on the risk of relapse after CD19 chimeric antigen receptor T Cell (Tisagenlecleucel) infusion in pediatric and young adult patients with relapse/refractory acute lymphoblastic leukemia: role of B-cell monitoring. (Pubmed Central) - Feb 4, 2024
CD19-positive relapse was also frequent in patients who lost BCA beyond six months post-infusion. Therefore, these patients are still at significant risk for relapse and close MRD monitoring and/or therapeutic interventions should be considered.
- | Ampligen (rintatolimod) / AIM ImmunoTech
Enrollment open, IO biomarker: Polarized Dendritic Cell (aDC1) Based Treatment, Interferon Alpha-2, Rintatolimod, and Celecoxib for the Treatment of HLA-A2+ Refractory Melanoma (clinicaltrials.gov) - Jan 30, 2024
P2, N=24, Recruiting, Sponsor: Roswell Park Cancer Institute
Therefore, these patients are still at significant risk for relapse and close MRD monitoring and/or therapeutic interventions should be considered. Suspended --> Recruiting
- | LCL161 / Novartis, birinapant (IGM-9427) / IGM Biosciences, JP1201 / Joyant Pharma
Journal: SMAC Mimetics for the Treatment of Lung Carcinoma: Present Development and Future Prospects. (Pubmed Central) - Jan 26, 2024
Suspended --> Recruiting SMAC mimetics acts in a restorative way in the prevention of lung cancer.
- |||||| Kymriah (tisagenlecleucel-T) / Novartis
Enrollment open: Effectiveness and Safety of Tisagenlecleucel Therapy in Brazilian Patients With B-lymphocyte Malignancies (clinicaltrials.gov) - Jan 16, 2024
P=N/A, N=200, Recruiting, Sponsor: Novartis Pharmaceuticals
SMAC mimetics acts in a restorative way in the prevention of lung cancer. Not yet recruiting --> Recruiting
- | birinapant (IGM-9427) / IGM Biosciences
Enrollment closed, Tumor mutational burden: Birinapant and Intensity Modulated Re-Irradiation Therapy in Treating Patients With Locally Recurrent Head and Neck Squamous Cell Carcinoma (clinicaltrials.gov) - Jan 11, 2024
P1, N=34, Active, not recruiting, Sponsor: National Cancer Institute (NCI)
Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting
- || Review, HEOR: A Systematic Literature Review of Health-Related Quality of Life Outcomes and Associated Utility Values in Relapsed and/or Refractory Large B Cell Lymphoma. (Pubmed Central) - Jan 10, 2024
Mixed results were found for novel therapies and salvage therapies. More data are needed as new therapies are used in this patient population to inform treatment decision-making.
- | Kymriah (tisagenlecleucel-T) / Novartis
Journal, Real-world evidence, Real-world: Challenges in the treatment of pediatric acute lymphoblastic leukemia: insights from the pediatric real world CAR consortium regarding nonresponse and relapse post tisagenlecleucel. (Pubmed Central) - Jan 10, 2024
More data are needed as new therapies are used in this patient population to inform treatment decision-making. No abstract available
- | Kymriah (tisagenlecleucel-T) / Novartis
Journal, IO biomarker: Durable Response After Tisagenlecleucel in Adults With Relapsed/Refractory Follicular Lymphoma: ELARA Trial Update. (Pubmed Central) - Jan 9, 2024
P2
No abstract available Low levels of tumor-infiltrating LAG3+CD3+ exhausted T-cells and higher baseline levels of na
- || Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
Retrospective data, Review, Journal, CAR T-Cell Therapy, Real-world evidence, Real-world: Real-world outcomes with CAR T-cell therapies in large B-cell lymphoma: a systematic review and meta-analysis. (Pubmed Central) - Jan 9, 2024
Our meta-analysis indicates that CAR T-cell therapies have manageable safety profiles and are effective in a wide range of patients with r/r LBCL, and that axi-cel is associated with improved OS and PFS and increased risk of Grade ?3 ICANS compared with tisa-cel. Limitations of this study include nonrandomized treatments, potential unknown prognostic factors, and the lack of available real-world data for liso-cel.
- || Kymriah (tisagenlecleucel-T) / Novartis
Review, Journal, CAR T-Cell Therapy: INSPIRED Symposium Part 4A: Access to CAR T cell Therapy in Unique Populations with B-cell Acute Lymphoblastic Leukemia. (Pubmed Central) - Jan 9, 2024
The approval of tisagenlecleucel (tisa-cel) for use in children with B cell acute lymphoblastic leukemia (B-ALL) was based on the phase 2 ELIANA trial, a global registration study...It is important to prospectively study patient-reported outcomes given the differential toxicity expected between CD19 CAR T cell therapy and the historic standard of care, hematopoietic cell transplant. Now that CD19 CAR T cell therapy is commercially available, studies evaluating potential access disparities created by this very expensive novel therapy are increasingly pressing.
- | Kymriah (tisagenlecleucel-T) / Novartis
Journal: Practice preferences for consolidative HSCT following tisagenlecleucel in children and young adults with B-ALL. (Pubmed Central) - Jan 9, 2024
The results of this survey indicate there exists significant practice variability regarding the use of cHSCT as well as interventions for post-tisagenlecleucel BCR or NGS positivity. These results highlight areas for which ongoing clinical trials could inform more standardized practice.
- || Review, Journal: A Review of Meaningful Change Thresholds for EORTC QLQ-C30 and FACT-G Within Oncology. (Pubmed Central) - Jan 9, 2024
Thresholds derived for a similar patient-population should be used where available. Further work is required to provide these across a broader range of cancer sites.
- | Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
Journal: Comparative efficacy and safety of tisagenlecleucel and axicabtagene ciloleucel among adults with r/r follicular lymphoma. (Pubmed Central) - Jan 5, 2024
Further work is required to provide these across a broader range of cancer sites. After adjustment for baseline differences in the trial populations, the results suggested that tisa-cel (n
- || aplitabart (IGM-8444) / IGM Biosciences
Trial completion date, Trial primary completion date: IGM-8444-001: Phase 1a/1b Study of Aplitabart (IGM-8444) Alone or in Combination in Participants With Relapsed, Refractory, or Newly Diagnosed Cancers (clinicaltrials.gov) - Jan 3, 2024
P1, N=430, Recruiting, Sponsor: IGM Biosciences, Inc.
After adjustment for baseline differences in the trial populations, the results suggested that tisa-cel (n Trial completion date: Jan 2027 --> Aug 2027 | Trial primary completion date: Nov 2026 --> Jun 2026
- | Kymriah (tisagenlecleucel-T) / Novartis
Trial completion date, Trial primary completion date: REFUEL: A Second Infusion (Early Reinfusion) of Tisagenlecleucel in Children and Young Adults With B-Cell Acute Lymphoblastic Leukemia(B-ALL) (clinicaltrials.gov) - Jan 1, 2024
P2, N=33, Recruiting, Sponsor: Memorial Sloan Kettering Cancer Center
- || BNT163 / BioNTech
Trial completion date, Trial primary completion date: A Clinical Trial in Healthy Volunteers and Volunteers with Recurrent Genital Herpes to Study the Safety, Tolerability, and Immune Responses After Vaccination with an Investigational Vaccine Designed to Prevent Genital Herpes Lesions (clinicaltrials.gov) - Dec 31, 2023
P1, N=108, Recruiting, Sponsor: BioNTech SE
- ||| Kymriah (tisagenlecleucel-T) / Novartis, Carvykti (ciltacabtagene autoleucel) / J&J
Journal, Adverse events, CAR T-Cell Therapy: Chimeric antigen receptor T-cell immunotherapies adverse events reported to FAERS database: focus on cytopenias. (Pubmed Central) - Dec 25, 2023
Cytopenias represent one of the most frequently reported AEs in FAERS, a CAR T-cell therapy is indicated, with haematopoetic leukopenia being the most common. When comparing different CAR-T cell therapies, the cytopenias' reporting odds ratio was particularly high for tisagenlecleucel, especially in relation to hematopoietic erythropenia.