A Study to Evaluate VIP152 in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia or Richter Syndrome

  • STATUS
    Recruiting
  • End date
    Feb 28, 2026
  • participants needed
    54
  • sponsor
    Vincerx Pharma, Inc.
Updated on 30 December 2021
chronic lymphocytic leukemia
venetoclax
richter syndrome

Summary

Determine the safety, tolerability, pharmacokinetics, maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of VIP152 in patients with Chronic Lymphocytic Leukemia (CLL) or Richter Syndrome

Details
Condition Relapsed Non Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Refractory Chronic Lymphocytic Leukemia, Richter Syndrome, MYC Amplification, MYC Overexpression, MYC Translocation
Treatment VIP152
Clinical Study IdentifierNCT04978779
SponsorVincerx Pharma, Inc.
Last Modified on30 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female patients aged >/=18 years
Patients with a histologically or cytologically
Confirmed CLL who are refractory to or have progressed from 2 or more regimens including BTKi and venetoclax or
Confirmed CLL transformed to DLBCL (Richter Syndrome) who have relapsed after, or been refractory, to at least 1 prior line of therapy for the DLBCL and having MYC overexpression/amplification/translocation
Adequate bone marrow, liver, and renal functions
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2

Exclusion Criteria

Active clinically serious infections of Grade > 2; requiring parenteral therapy
Subjects who have new or progressive brain or meningeal or spinal metastases
Anticancer chemotherapy or immunotherapy during the study or within one week prior to the first dose of study drug
Major surgery or significant trauma within 4 weeks before the first dose of study drug
Allogeneic bone marrow transplant or stem cell rescue within 4 months before first dose of study drug; patients must have completed immunosuppressive therapy before enrollment
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