rapcabtagene autoleucel (YTB323) / Novartis 
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  • ||||||||||  rapcabtagene autoleucel (YTB323) / Novartis
    Trial completion date:  CYTB323A12101: Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL (clinicaltrials.gov) -  Oct 8, 2024   
    P1/2,  N=225, Recruiting, 
    Although pt numbers were limited, risk-benefit analysis supports use of the lower-dose LD regimen before infusion; continued assessment of long-term efficacy and safety outcomes is needed. Trial completion date: Jun 2027 --> May 2028
  • ||||||||||  MODULE 5: Chimeric Antigen Receptor (CAR) T-Cell Therapy and Other Novel Strategies for CLL (Manchester Grand Hyatt San Diego, Seaport Ballroom EFGH; In-Person; Virtual) -  Oct 5, 2024 - Abstract #ASH2024ASH_79;    
    Trial completion date: Jun 2027 --> May 2028 This program is supported by educational grants from AstraZeneca Pharmaceuticals LP, BeiGene Ltd and Eli Lilly.Biological rationale for the investigation of CD19- directed CAR T-cell therapy for CLL Published efficacy and safety findings with lisocabtagene maraleucel (liso-cel) for R/R CLL from the Phase I/II TRANSCEND CLL 004 trial FDA approval of liso-cel for CLL previously treated with a BTK inhibitor and a Bcl-2 inhibitor; current clinical role and optimal patient selection Early findings with other CAR T-cell-based approaches (eg, liso-cel in combination with ibrutinib, brexucabtagene autoleucel, rapcabtagene autoleucel) for heavily pretreated CLL Antitumor activity observed with bispecific antibody therapy (eg, epcoritamab, NVG-111, LAVA-051) for CLL, including in patients with Richter's transformation Other promising agents and strategies under investigation for CLL
  • ||||||||||  MODULE 4: Incorporation of Chimeric Antigen Receptor (CAR) T-Cell Therapy into the Management of DLBCL (Omni San Diego, Grand Ballroom (Level 2), 4; Virtual) -  Sep 23, 2023 - Abstract #ASH2023ASH_258;    
    Supported by educational grants from ADC Therapeutics, Genentech, a member of the Roche Group, Incyte Corporation, Kite, A Gilead Company, and Regeneron Pharmaceuticals Inc. Optimal timing for referral of patients with DLBCL for CAR T-cell therapy Major findings from Phase III studies with CAR T-cell therapy as second-line treatment for DLBCL FDA approvals of axi-cel and lisocabtagene maraleucel (liso-cel) as second-line therapy and identification of candidates for this strategy Long-term efficacy and safety data with axi-cel, tisagenlecleucel and liso-cel in multiregimen-relapsed DLBCL Spectrum, frequency and severity of adverse events (AEs) associated with CAR T-cell therapy for DLBCL, including cytokine release syndrome (CRS) and neurotoxicity Early results with other CAR T-cell platforms for DLBCL, such as rapcabtagene autoleucel
  • ||||||||||  rapcabtagene autoleucel (YTB323) / Novartis
    Enrollment change, Trial completion date, Trial primary completion date, CAR T-Cell Therapy:  CYTB323A12101: Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL (clinicaltrials.gov) -  Mar 8, 2023   
    P1,  N=225, Recruiting, 
    Phase classification: P1 --> P1/2 N=110 --> 225 | Trial completion date: Oct 2025 --> Jun 2027 | Trial primary completion date: Oct 2025 --> Jun 2027
  • ||||||||||  YTB323 / Novartis
    PHASE I STUDY OF YTB323, A CHIMERIC ANTIGEN RECEPTOR (CAR)-T CELL THERAPY MANUFACTURED USING T-CHARGE™, IN PATIENTS WITH RELAPSED/REFRACTORY DIFFUSE LARGE B-CELL LYMPHOMA (Hall A7) -  May 13, 2022 - Abstract #EHA2022EHA_2643;    
    P1
    Tocilizumab and corticosteroids were used for CRS management in 4 (80%) and 2 (40%) pts at DL2, respectively...YTB323 expansion (C max and AUC 0-28d ) with 12.5×10 6 CAR+ cells (DL2) was comparable to a median tisagenlecleucel dose of 312×10 6 CAR+ cells in pts with DLBCL, a 25-fold lower median dose (Awasthi R, et al...Conclusion YTB323 is a potent new CAR-T cell tx with distinct cellular kinetics, encouraging early efficacy results across DL1 and DL2, and a manageable safety profile. Updated results will be presented at the meeting along with a recommended dose for subsequent trials.
  • ||||||||||  YTB323 / Novartis, PHE885 / Novartis, Kymriah (tisagenlecleucel-T) / Novartis
    Novel Benchmark Scaling Method for First-in-Human Dose of CAR-T Therapies (Poster Board Number: W-250; Hall D) -  Apr 20, 2022 - Abstract #ASGCT2022ASGCT_748;    
    P1
    Result The development of a CD19-targeted CAR-T (YTB323) and a BCMA-targeted CAR-T (PHE885) with a new optimized manufacturing method (T-ChargeTM) are used as examples...Assuming a comparable safety profile based on the same mechanism of action as CTL019, an YTB323 dose up to 2.8×107 cells (highest CTL019 dose with manageable AEs from another study UPCC03712 of 1.1×109 cells divided by 40) should be tolerable...In a second example, the target starting dose for PHE885 was derived based on preclinical comparison and clinical data generated with MCM998, another BCMA-targeted CAR-T previously tested in r/r multiple myeloma patients (NCT02546167)...Conclusion The proposed method to calculate FIH starting dose mitigates the current limitation in preclinical-to-clinical translation in CAR-T therapy. Examples of two CAR-Ts with different targets and indications demonstrated the general utility of the approach.
  • ||||||||||  rapcabtagene autoleucel (YTB323) / Novartis
    Trial completion date, Trial primary completion date, CAR T-Cell Therapy:  CYTB323A12101: Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL (clinicaltrials.gov) -  May 14, 2021   
    P1,  N=110, Recruiting, 
    Current data support continued development of YTB323 in r/r DLBCL pts. Trial completion date: Mar 2024 --> Oct 2025 | Trial primary completion date: Mar 2024 --> Oct 2025
  • ||||||||||  rapcabtagene autoleucel (YTB323) / Novartis
    Enrollment change, Trial completion date, Trial primary completion date, CAR T-Cell Therapy:  CYTB323A12101: Phase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, r/r ALL and 1L HR LBCL (clinicaltrials.gov) -  Aug 7, 2020   
    P1,  N=110, Recruiting, 
    Trial completion date: Mar 2024 --> Oct 2025 | Trial primary completion date: Mar 2024 --> Oct 2025 N=50 --> 110 | Trial completion date: Jan 2023 --> Mar 2024 | Trial primary completion date: Jan 2023 --> Mar 2024