- |||||||||| 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.
- |||||||||| MCC1 TCR - Fred Hutchinson Cancer Center, Affini / T Therap, Regeneron
Enrollment closed, Enrollment change, Trial completion date, Trial primary completion date, Metastases, Immune cell: ATTAC-MCC: Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer (clinicaltrials.gov) - Mar 26, 2024 P1/2, N=7, Active, not recruiting, Active, not recruiting --> Terminated; Terminated due to slow enrollment and end of funding Recruiting --> Active, not recruiting | N=16 --> 7 | Trial completion date: Apr 2025 --> Jan 2025 | Trial primary completion date: Apr 2024 --> Jan 2024
- |||||||||| Breyanzi (lisocabtagene maraleucel) / BMS, Yescarta (axicabtagene ciloleucel) / Gilead, JCAR014 / BMS
Early Prediction of Severe Icans after CD19 CAR T-Cell Therapy Based on Serum Ferritin Levels () - Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_921; Serum ferritin levels on day +3 are strongly associated with severe ICANS after CD19 CAR T-cell therapy with axi-cel and liso-cel, and was validated in an external cohort including clinical trial patients treated with JCAR014. Validated predictive models using point-of-care assessments create an opportunity to identify high-risk patients who could benefit from early or prophylactic interventions.
- |||||||||| Impact of Gamma-Secretase Inhibition on the Multiple Myeloma Immune Microenvironment (SDCC - Halls G-H) - Nov 3, 2023 - Abstract #ASH2023ASH_6134;
These results provide strong rationale for advancing this therapeutic approach to clinical development. In a phase I, first-in-human clinical trial (n=18; relapsed/refractory MM) combining the GSI, crenigacestat, with anti-BCMA CAR T-cell therapy (FCARH143), we recently demonstrated that plasma cell BCMA antibody-binding capacity increased a median of 12-fold among 17/18 (94%) of participants after they received a 5-day GSI
- |||||||||| Imfinzi (durvalumab) / AstraZeneca, JCAR014 / BMS
Journal, CAR T-Cell Therapy: Timing of Anti-PD-L1 Antibody Initiation Affects Efficacy/Toxicity of CD19 CAR-T Cell Therapy for Large B-Cell Lymphoma. (Pubmed Central) - Oct 30, 2023 Despite the lack of efficacy improvement and similar CAR-T cell kinetics, ongoing durvalumab therapy after JCAR014 was associated with re-expansion of CAR-T cells in blood, late regression of CD19+ and CD19- tumors, and enhanced duration of response. Our results indicate that the timing of initiation of PD-L1 blockade is a key variable that affects outcomes after CD19 CAR-T cell immunotherapy for adults with LBCL.
- |||||||||| MB-106 / Fortress
CD20 CAR-T THERAPY WITH MB-106 FOR BTK INHIBITOR-REFRACTORY WALDENSTR (Poster area) - May 12, 2023 - Abstract #EHA2023EHA_1371; MB-106 has received orphan drug designation by the US FDA for WM, and a multicenter study is currently active in the US for WM and other B-NHLs. Enrollment also continues in this single institution study, and the results will be updated during the presentation.
- |||||||||| PRAME mTCR CAR T / Fred Hutchinson Cancer Research Center
Preclinical evaluation of targeting PRAME with TCR mimic CAR T cells in AML. (On Demand | Hall A; Poster Bd # 395) - Apr 26, 2023 - Abstract #ASCO2023ASCO_2321; We show potent efficacy with eradication of leukemia in PDX-bearing mice following treatment with PRAME mTCRCAR T cells resulting in prolonged survival. These results provide a novel approach to target PRAME with CAR T cells and provide compelling data to evaluate PRAME mTCRCAR T cells for use in clinical trials against AML.
- |||||||||| PRAME mTCR CAR T / Fred Hutchinson Cancer Research Center
Journal, CAR T-Cell Therapy, IO biomarker: Therapeutic targeting PRAME with mTCRCAR T cells in acute myeloid leukemia. (Pubmed Central) - Apr 4, 2023 Furthermore, the cytolytic activity of PRAME mTCRCAR T cells was enhanced by treating the target cells with IFN-?, which increases PRAME antigen expression. These results demonstrate the feasibility and efficacy of targeting PRAME with novel PRAME mTCRCAR T cells.
- |||||||||| BCMA targeted CAR T / Fred Hutchinson Cancer Research Center
Journal, CAR T-Cell Therapy: Anti-HLA antibodies in recipients of CD19 versus BCMA-targeted CAR T-cell therapy. (Pubmed Central) - Mar 14, 2023 These data implicate CD19 long-lived plasma cells as an important source for anti-HLA antibodies, a model supported by infrequent HLA sensitization in BCMA-CARTx subjects receiving previous plasma cell-targeted therapies. Thus, plasma cell-targeted therapies may be more effective against HLA antibodies, thereby enabling improved access to organ transplantation and rejection management.
- |||||||||| FH-MagIC TCR-T / Fred Hutchinson Cancer Center, SignalOne Bio
Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Metastases: ATTAMAGE-A1: Genetically Engineered Cells (MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells) and Atezolizumab for the Treatment of Metastatic Triple Negative Breast Cancer, Urothelial Cancer, or Non-small Cell Lung Cancer (clinicaltrials.gov) - Dec 13, 2022 P1/2, N=1, Terminated, A new cohort including pts in relapse after murine scFv-containing CD19 CAR T cell therapy is currently enrolling. N=18 --> 1 | Trial completion date: Apr 2023 --> Aug 2022 | Suspended --> Terminated | Trial primary completion date: Apr 2023 --> Aug 2022; Terminated due to slow accrual.
- |||||||||| JCAR014 / BMS
CAR T-Cell Therapy for Relapsed or Refractory Large B-Cell Lymphoma Using a Fully Human CD19-Targeted Single Chain Variable Fragment: Results of a First-in-Human Phase I/II Study (ENMCC - Hall D) - Nov 4, 2022 - Abstract #ASH2022ASH_6484; P1, P1/2 All patients received lymphodepletion (LD) with cyclophosphamide 300 mg/m2/d and fludarabine 30 mg/m2/d for 3 days, followed by JCAR021 infusion...Consistent with the higher JCAR021 RP2D compared to JCAR014, we observed after JCAR021 better OR (87% versus 59%, respectively), CR rates (67% versus 53%, respectively), and PFS (12-month PFS, 47% versus 25%; CR pts, 64% versus 37%, respectively; Figure B)...At the RP2D, high rates of durable responses were observed. A new cohort with pts in relapse after murine scFv-containing CD19 CAR T cell therapy is currently enrolling.
- |||||||||| FCARH143 / BMS, Fred Hutchinson Cancer Research Center, National Cancer Institute
Trial completion, Trial completion date, CAR T-Cell Therapy, Metastases: Immunotherapy With BCMA CAR-T Cells in Treating Patients With BCMA Positive Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - Aug 5, 2022 P1, N=28, Completed, Trial completion date: Nov 2023 --> Nov 2024 | Trial primary completion date: Nov 2023 --> Nov 2024 Active, not recruiting --> Completed | Trial completion date: Dec 2037 --> Mar 2022
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead, Daiichi Sankyo, JCAR014 / BMS
Journal, CAR T-Cell Therapy: Impact of CD19 CAR T-cell product type on outcomes in relapsed or refractory aggressive B-NHL. (Pubmed Central) - Jul 6, 2022 P1/2 Higher preleukapheresis LDH, largest lesion diameter, and lower ALC were independently associated with lower odds of CR. We conclude that CD19 CAR T-cell product type independently impacts toxicity and efficacy in R/R aggressive B-NHL patients.
- |||||||||| FH-MagIC TCR-T / Fred Hutchinson Cancer Center, SignalOne Bio
Trial completion date, Trial suspension, Trial primary completion date, Metastases: ATTAMAGE-A1: Genetically Engineered Cells (MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells) and Atezolizumab for the Treatment of Metastatic Triple Negative Breast Cancer, Urothelial Cancer, or Non-small Cell Lung Cancer (clinicaltrials.gov) - May 27, 2022 P1/2, N=18, Suspended, Trial completion date: Oct 2023 --> Dec 2025 | Trial primary completion date: Oct 2023 --> Dec 2025 Trial completion date: Dec 2024 --> Apr 2023 | Recruiting --> Suspended | Trial primary completion date: Dec 2024 --> Apr 2023
- |||||||||| MB-106 / Fortress
EFFICACY AND SAFETY OF A THIRD GENERATION CD20 CART (MB-106) FOR TREATMENT OF RELAPSED/REFRACTORY FOLLICULAR LYMPHOMA (FL) (Hall C1) - May 13, 2022 - Abstract #EHA2022EHA_2715; Chimeric antigen receptor T-cells (CAR-T) targeting CD19 are effective, and axicabtagene ciloleucel is currently approved by FDA for treatment of patients (pts) with relapsed FL, but toxicities like cytokine-release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) may limit its use...Lymphodepletion (LD) consists of cyclophosphamide (Cy) ± fludarabine (Flu)...Median time between leukapheresis and LD was 15 days (range: 9-21) and 2 pts received bridging therapy with lenalidomide (1) and high-dose corticosteroids (1)...Conclusion Treatment with MB-106, a third generation CD20 targeting CAR-T, resulted in high ORR and CR rates and CAR-T persistence in FL pts and was associated with favorable safety profile with no occurrence of Gr 3 or Gr 4 CRS and no ICANS event of any grade. A multicenter trial for treatment of B-cell malignancies including FL will start enrollment in 2022.
|