tenalisib (RP6530) / Rhizen 
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 11 Diseases   2 Trials   2 Trials   100 News 


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  • ||||||||||  CN1 / Curon Biopharma, tenalisib (RP6530) / Rhizen
    Enrollment change, Trial completion date, Trial termination, Combination therapy:  A Study of CN1 in Combination With CN401 in Adult Patients With Relapsed/Refractory Lymphoid Malignancies (clinicaltrials.gov) -  Oct 24, 2022   
    P1/2,  N=7, Terminated, 
    Clinical trial information: NCT05021900. N=78 --> 7 | Trial completion date: Jul 2023 --> Sep 2022 | Recruiting --> Terminated; Sponsor decided that there was no benefit in the drug treatment and due to company change in landscape in the new year.
  • ||||||||||  tenalisib (RP6530) / Rhizen
    Enrollment change, Trial completion date, Trial primary completion date:  Compassionate Use Study of Tenalisib (RP6530) (clinicaltrials.gov) -  Nov 2, 2021   
    P1/2,  N=17, Enrolling by invitation, 
    Based on these encouraging results, further development of this combination in PTCL patients in being planned. N=10 --> 17 | Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Oct 2021 --> Oct 2022
  • ||||||||||  tenalisib (RP6530) / Rhizen
    Trial completion date, Trial primary completion date:  Compassionate Use Study of Tenalisib (RP6530) (clinicaltrials.gov) -  Dec 4, 2020   
    P1/2,  N=10, Enrolling by invitation, 
    Trial primary completion date: Dec 2020 --> May 2021 Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Oct 2020 --> Oct 2021
  • ||||||||||  azacitidine / Generic mfg., tenalisib (RP6530) / Rhizen
    [VIRTUAL] THERAPEUTIC POTENTIAL OF TENALISIB, A PI3K DELTA/GAMMA PLUS SIK-3 INHIBITOR, IN HEMATOLOGICAL MALIGNANCIES () -  May 16, 2020 - Abstract #EHA2020EHA_748;    
    A Phase 1/2 study evaluating the safety and efficacy of Tenalisib in combination with Romidepsin in relapsed/refractory T-cell lymphoma is currently ongoing in the USA...Cell growth following incubation (72 h) with IN0385 as a single agent or in combination with Azacytidine, or Venetoclax was determined in the AML lines: THP-1, U937, and MV-4-11...Gene expression studies in specific cell types and xenograft models are currently underway to further elucidate the role and utility of IN0385 in other hematological malignancies. A Phase-1 trial in relapsed/refractory AML is planned.
  • ||||||||||  tenalisib (RP6530) / Rhizen
    Enrollment status:  Compassionate Use Study of Tenalisib (RP6530) (clinicaltrials.gov) -  Oct 29, 2019   
    P1/2,  N=10, Enrolling by invitation, 
    Currently, a phase I/II combination study to further evaluate safety and efficacy with romidepsin is ongoing in this target population. Recruiting --> Enrolling by invitation
  • ||||||||||  Jakafi oral (ruxolitinib) / Novartis, Incyte
    Journal:  Development of new agents for peripheral T-cell lymphoma. (Pubmed Central) -  Jun 9, 2019   
    In addition, mogamulizumab (anti-CC chemokine receptor 4 antibody), chidamide (histone deacetylase inhibitor), and forodesine (purine nucleoside phosphorylase inhibitor) have been approved in Asian countries, including China, and Japan...However, these are not a curative option when used as a single agent. Further clinical developments are expected, comprising 1) combination therapies of new agents with cytotoxic chemotherapies; 2) "novel-novel" combinations; 3) immune therapies, including chimeric antigen receptor T-cell therapy; and 4) predictive marker analysis.
  • ||||||||||  tenalisib (RP6530) / Rhizen
    Enrollment open, Combination therapy, Epigenetic controller:  Safety and Efficacy of Tenalisib (RP6530) in Combination With Romidepsin in Patients With Relapsed/Refractory T-cell Lymphoma (clinicaltrials.gov) -  Mar 22, 2019   
    P1/2,  N=42, Recruiting, 
    Further clinical developments are expected, comprising 1) combination therapies of new agents with cytotoxic chemotherapies; 2) "novel-novel" combinations; 3) immune therapies, including chimeric antigen receptor T-cell therapy; and 4) predictive marker analysis. Not yet recruiting --> Recruiting
  • ||||||||||  tenalisib (RP6530) / Rhizen
    Enrollment change, Trial completion date, Trial termination, Trial primary completion date, Combination therapy:  Safety and Efficacy Study of Tenalisib (RP6530) in Combination With Pembrolizumab in Relapsed or Refractory cHL (clinicaltrials.gov) -  Feb 26, 2019   
    P1/2,  N=2, Terminated, 
    Initiation date: Dec 2018 --> Mar 2019 N=57 --> 2 | Trial completion date: Dec 2019 --> Feb 2019 | Recruiting --> Terminated | Trial primary completion date: Aug 2019 --> Feb 2019; At this point, the current study in HL does not fit into clinical development and regulatory strategy.
  • ||||||||||  tenalisib (RP6530) / Rhizen
    Trial completion:  Safety and Efficacy Study of a Dual PI3K Delta/Gamma Inhibitor in T-cell Lymphoma (clinicaltrials.gov) -  Dec 13, 2018   
    P1,  N=58, Completed, 
    N=57 --> 2 | Trial completion date: Dec 2019 --> Feb 2019 | Recruiting --> Terminated | Trial primary completion date: Aug 2019 --> Feb 2019; At this point, the current study in HL does not fit into clinical development and regulatory strategy. Active, not recruiting --> Completed