RVT-1801 / Roivant 
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  • ||||||||||  RVT-1801 / Roivant
    Trial completion date, Trial primary completion date:  MOMENTUM: Gene Transfer for Patients With Sickle Cell Disease (clinicaltrials.gov) -  Jul 20, 2023   
    P1/2,  N=7, Active, not recruiting, 
    Trial completion date: Jun 2035 --> Jul 2038 | Trial primary completion date: Jun 2023 --> Jul 2037
  • ||||||||||  RVT-1801 / Roivant
    Enrollment closed, Enrollment change:  MOMENTUM: Gene Transfer for Patients With Sickle Cell Disease (clinicaltrials.gov) -  Jul 20, 2022   
    P1/2,  N=7, Active, not recruiting, 
    Trial completion date: Jun 2035 --> Jul 2038 | Trial primary completion date: Jun 2023 --> Jul 2037 Recruiting --> Active, not recruiting | N=10 --> 7
  • ||||||||||  RVT-1801 / Roivant
    STABLE TRANSDUCTION OF FETAL HEMOGLOBIN IN PATIENTS WITH SICKLE CELL DISEASE IN THE PHASE 1/2 MOMENTUM STUDY OF ARU-1801 GENE THERAPY AND REDUCED INTENSITY CONDITIONING () -  May 13, 2022 - Abstract #EHA2022EHA_1400;    
    P1/2
    We have previously shown (1) ARU-1801 can reach effective levels of anti-sickling hemoglobin at VCN ≤1, with 42% HbF G16D expression per DP VCN and (2) HbF G16D may have a more potent anti-sickling effect than endogenous HbF. Along with these effects, strong long-term HSC engraftment (as demonstrated by high, stable ratios of PB to DP VCN) requiring only RIC makes ARU-1801 a promising gene therapy alternative to treatments that require myeloablative conditioning, offering amelioration of SCD phenotype without the toxicities and resource utilization of full myeloablation.
  • ||||||||||  RVT-1801 / Roivant
    Enrollment open:  MOMENTUM: Gene Transfer for Patients With Sickle Cell Disease (clinicaltrials.gov) -  Aug 26, 2021   
    P1/2,  N=10, Recruiting, 
    The second patient had lower HSC engraftment due to below-target melphalan exposure (likely caused by renal hyperfiltration), with 14% HbF and 5% HbA2 at three years. Active, not recruiting --> Recruiting
  • ||||||||||  RVT-1801 / Roivant
    [VIRTUAL] Aruvant Sciences () -  May 31, 2021 - Abstract #BIO2021BIO_245;    
    For more information on the ongoing ARU-1801 clinical study, please visit www.momentumtrials.com and for more on the company, please visit www.aruvant.com . Follow Aruvant on Facebook , Twitter @AruvantSciences and on Instagram @Aruvant_Sciences .
  • ||||||||||  Zarzio (filgrastim biosimilar) / Novartis, RVT-1801 / Roivant
    [VIRTUAL] TOWARDS PATIENT-SPECIFIC DOSING OF MELPHALAN CONDITIONING FOR ARU-1801, A NOVEL GENE THERAPY FOR TREATMENT OF SICKLE CELL DISEASE () -  May 13, 2021 - Abstract #EHA2021EHA_1410;    
    Background Sickle cell disease (SCD) is a severe genetic disease for which the only cure is allogeneic hematopoietic stem cell transplant (HSCT), but this procedure requires myeloablative conditioning (usually with busulfan) to allow donor cell engraftment at the risk of chemotherapy-related toxicities, including short-term (e.g. neutropenia, veno-occlusive disease) and long-term (e.g. ovarian failure, secondary leukemia) effects...These data suggest individualized melphalan dosing prior to ARU-1801 infusion may be feasible; additional data will be used to refine the PK model for patients with SCD. A simple melphalan dose adjustment algorithm based on few covariate values has the potential to reduce variability and optimize melphalan exposure, which may result in improved patient outcomes after treatment with ARU-1801.
  • ||||||||||  RVT-1801 / Roivant
    Enrollment closed:  MOMENTUM: Gene Transfer for Patients With Sickle Cell Disease (clinicaltrials.gov) -  Mar 1, 2021   
    P1/2,  N=10, Active, not recruiting, 
    These results are an encouraging sign of the therapeutic benefit of ARU-1801 with RIC for patients with SCD. Recruiting --> Active, not recruiting
  • ||||||||||  RVT-1801 / Roivant
    Trial completion date, Trial primary completion date:  MOMENTUM: Gene Transfer for Patients With Sickle Cell Disease (clinicaltrials.gov) -  May 8, 2020   
    P1/2,  N=10, Recruiting, 
    P2 had lower HSCP engraftment, which we hypothesize was due to below target melphalan exposure. Trial completion date: Dec 2035 --> Jun 2035 | Trial primary completion date: Dec 2035 --> Jun 2023
  • ||||||||||  RVT-1801 / Roivant
    Trial completion date, Trial primary completion date:  MOMENTUM: Gene Transfer for Patients With Sickle Cell Disease (clinicaltrials.gov) -  May 6, 2019   
    P1/2,  N=10, Recruiting, 
    Trial completion date: Dec 2035 --> Jun 2035 | Trial primary completion date: Dec 2035 --> Jun 2023 Trial completion date: Aug 2033 --> Dec 2035 | Trial primary completion date: Aug 2032 --> Dec 2035
  • ||||||||||  RVT-1801 / Roivant
    Trial primary completion date:  MOMENTUM: Gene Transfer for Patients With Sickle Cell Disease (clinicaltrials.gov) -  Aug 30, 2017   
    P1/2,  N=10, Recruiting, 
    Trial completion date: Aug 2033 --> Dec 2035 | Trial primary completion date: Aug 2032 --> Dec 2035 Trial primary completion date: Jul 2017 --> Aug 2032