- |||||||||| Review, Journal: The Implementation of Chimeric Antigen Receptor (CAR) T-cell Therapy in Pediatric Patients: Where Did We Come From, Where Are We Now, and Where are We Going? (Pubmed Central) - May 31, 2024
By comparison, only a single CAR-T cell therapy is approved by the FDA for pediatric patients: tisagenlecleucel, which is approved for patients ? 25 years with refractory B-cell precursor ALL, or B-cell ALL in second or later relapse...All the other FDA-approved CD19-directed CAR-T cell therapies available for adult patients (axicabtagene ciloleucel, brexucabtagene autoleucel, and lisocabtagene maraleucel) are currently under investigations among children, with preliminary results available in some cases...This is particularly true when considering "atypical" situations, e.g.
- |||||||||| Kineret (anakinra) / SOBI
Trial completion, Trial completion date, Trial primary completion date: Anakinra for the Reduction of CAR-T Toxicity in Patients With Relapsed or Refractory Large B-cell Lymphoma (clinicaltrials.gov) - May 31, 2024 P2, N=22, Completed, 25 years with refractory B-cell precursor ALL, or B-cell ALL in second or later relapse...All the other FDA-approved CD19-directed CAR-T cell therapies available for adult patients (axicabtagene ciloleucel, brexucabtagene autoleucel, and lisocabtagene maraleucel) are currently under investigations among children, with preliminary results available in some cases...This is particularly true when considering "atypical" situations, e.g. Active, not recruiting --> Completed | Trial completion date: Jan 2025 --> May 2024 | Trial primary completion date: Jan 2025 --> May 2024
- |||||||||| ProstVac (rilimogene galvacirepvec) / Bavarian Nordic
Trial completion, Combination therapy: PROSTVAC in Combination With Nivolumab in Men With Prostate Cancer (clinicaltrials.gov) - May 31, 2024 P1/2, N=24, Completed, Active, not recruiting --> Completed | Trial completion date: Jan 2025 --> May 2024 | Trial primary completion date: Jan 2025 --> May 2024 Active, not recruiting --> Completed
- |||||||||| Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
Retrospective data, Review, Journal, CAR T-Cell Therapy: Safety and Toxicity Profiles of CAR T Cell Therapy in Non-Hodgkin Lymphoma: A Systematic Review and Meta-Analysis. (Pubmed Central) - May 30, 2024 Overall, this study serves as the first to delineate toxicity profiles associated with various available CAR T products. By better understanding associated toxicities, it may become possible to tailor therapies towards individual patients and anticipate the development of toxicities at earlier stages.
- |||||||||| Keytruda (pembrolizumab) / Merck (MSD), Ad-CCL21-DC / National Cancer Institute
Enrollment closed, Trial completion date, Trial primary completion date, Metastases: HEMONC CIRM IST Lung: CCL21-Gene Modified Dendritic Cell Vaccine and Pembrolizumab in Treating Patients With Stage IV Non-small Cell Lung Cancer (clinicaltrials.gov) - May 8, 2024 P1, N=24, Active, not recruiting, Not yet recruiting --> Recruiting Recruiting --> Active, not recruiting | Trial completion date: Jun 2025 --> Jan 2025 | Trial primary completion date: Jun 2024 --> Jan 2024
- |||||||||| Yescarta (axicabtagene ciloleucel) / Gilead
Journal, CAR T-Cell Therapy: Effect of delayed cell infusion in patients with large B-cell lymphoma treated with chimeric antigen receptor T-cell therapy. (Pubmed Central) - May 2, 2024 We performed a retrospective analysis of 240 patients with relapsed/refractory large B-cell lymphoma treated with standard-of-care axicabtagene ciloleucel (axi-cel) and identified 40 patients (16.7%) who had delay in axi-cel infusion...Together, these findings suggest that delays in CAR T-cell administration after initiation of LDC are associated with inferior outcomes. Further studies are needed to guide strategies to improve efficacy in such patients.
- |||||||||| Review, Journal, IO biomarker: Immunotherapy of Hematological Malignancies of Human B-Cell Origin with CD19 CAR T Lymphocytes. (Pubmed Central) - Apr 26, 2024
In this review, we highlight the current information on traditional treatments of NHL and ALL, the design and manufacturing of various generations of CAR T-cells, the FDA approval of Kymriah, Yescarta Tecartus, and Breyanzi, and a summary of prominent clinical trials and the notable disadvantages of treatments. We further discuss approaches to potentially enhance CAR T-cell therapy for these malignancies, such as the inclusion of a suicide gene and use of FDA-approved drugs.
- |||||||||| Review, Journal: Advancements in the Management of Follicular Lymphoma: A Comprehensive Review. (Pubmed Central) - Apr 25, 2024
Given encouraging outcomes with CAR T cell therapy and BsAbs, multiple trials are testing these highly active agents in earlier lines of therapy and among high-risk patients with early relapse after frontline chemoimmunotherapy. Additonal studies and follow-up are needed to understand how these novel agents may further change treatment algorithms for FL.
- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma, Yescarta (axicabtagene ciloleucel) / Gilead
Association between post-CART terminal complement complex (TCC) levels and clinically significant immune effector cell (Hall A; Poster Bd # 19) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2373; We retrospectively included 42 patients (pts) with B-cell non-Hodgkin lymphoma treated with axi-cel or brexu-cel from 03/2022 - 09/2023 at Ohio State University who had had sC5b-9 levels available pre-lymphodepletion (pre-LD), pre-CART and post-CART infusion...Tocilizumab and steroids were used in 28 (67%) and 20 (48%) of the pts, respectively... Our findings support an association between post-CART sC5b-9 levels and clinically significant ICANS warranting further investigation of the role of complement in the ICANS pathogenesis and as a therapeutic target.
- |||||||||| Secondary myeloid malignancy after CAR T cell therapy for non-Hodgkin lymphoma (NHL). (Hall A; Poster Bd # 16) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2370;
We report on incidence of secondary myeloid malignancy in pt receiving CART for NHL. Mutational characteristics of secondary malignancies were those classically associated with therapy-related myeloid malignancy, thus presumed to be associated with prior exposure to chemotherapy (eg. alkylators/VP-16).
- |||||||||| Breyanzi (lisocabtagene maraleucel) / BMS, Yescarta (axicabtagene ciloleucel) / Gilead, JCAR014 / BMS
Predictors of severe hematotoxicity after CAR T-cell therapy. (Hall A; Poster Bd # 7) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2361; We identified pre- and post-infusion predictors of grade 3-4 ICAHT and internally validated a multivariable logistic regression model including disease-type, pre-LD ANC, pre-LD LDH, peak CRP, peak ferritin, and CRS grade. We plan to further evaluate our model in an external cohort.
- |||||||||| Breyanzi (lisocabtagene maraleucel) / BMS, Yescarta (axicabtagene ciloleucel) / Gilead, JCAR014 / BMS
Improving the ICAHT grading criteria using time-series clustering. (Hall A; Poster Bd # 1) - Apr 24, 2024 - Abstract #ASCO2024ASCO_2356; Unsupervised time-series clustering identified patterns of ANC recovery not captured by the ICAHT grading system and more strongly associated with OS than ICAHT grades. Incorporating these distinct patterns of recovery into a modified ICAHT grading system improved predictions of OS compared to the original ICAHT grades.
- |||||||||| Kineret (anakinra) / SOBI
Enrollment closed, Trial completion date, Trial primary completion date, CAR T-Cell Therapy: A Phase 2 Trial of Anakinra for the Prevention of CAR-T Cell Mediated Neurotoxicity (clinicaltrials.gov) - Apr 23, 2024 P2, N=15, Active, not recruiting, Over 3 years, the estimated cumulative per patient cost of mosunetuzumab is lower than most available newer therapies, resulting in a small increase in the budget after its formulary adoption for the treatment of relapsed or refractory follicular lymphoma. Completed --> Active, not recruiting | Trial completion date: Oct 2023 --> Oct 2025 | Trial primary completion date: Oct 2022 --> Oct 2024
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis, Tecartus (brexucabtagene autoleucel) / Gilead, Yescarta (axicabtagene ciloleucel) / Gilead
Journal, CAR T-Cell Therapy: Early CAR- CD4+ T-lymphocytes recovery following CAR-T cell infusion: A worse outcome in diffuse large B cell lymphoma. (Pubmed Central) - Apr 18, 2024 ZUMA-1 (NCT02348216) and ZUMA-7 (NCT03391466), both registered on ClinicalTrials.gov. Among possible determinants of CD4+ T cell recovery, we recognized infusion of a 4-1BB product (tisagenlecleucel, TSA) in comparison with a CD28 (axicabtagene/brexucabtagene, AXI/BRX) (hazard ratio [HR] [95% CI]: 5.79 [1.16-24.12] p
- |||||||||| Trial completion date, Trial primary completion date: Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - Apr 11, 2024
P2, N=700, Enrolling by invitation, Among possible determinants of CD4+ T cell recovery, we recognized infusion of a 4-1BB product (tisagenlecleucel, TSA) in comparison with a CD28 (axicabtagene/brexucabtagene, AXI/BRX) (hazard ratio [HR] [95% CI]: 5.79 [1.16-24.12] p Trial completion date: Mar 2041 --> Dec 2040 | Trial primary completion date: Mar 2041 --> Dec 2040
- |||||||||| Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
Journal, HEOR, Cost-effectiveness, Cost effectiveness: Cost-effectiveness analysis 3L of axicabtagene ciloleucel vs tisagenlecleucel and lisocabtagene maraleucel in Japan. (Pubmed Central) - Apr 10, 2024 Trial completion date: Mar 2041 --> Dec 2040 | Trial primary completion date: Mar 2041 --> Dec 2040 Results & Axi-cel was associated with greater incremental life years (3.13 and 2.85) and incremental quality-adjusted life-years (2.65 and 2.24), thus generated lower incremental direct medical costs (-$976.29 [-
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