A Clinical Study of HDP-102 in Patients with Relapsed/Refractory B-cell Blood Cancers.

Study Identifier:
HDP-102-01
CT.gov Identifier:
N/A
EudraCT Identifier:
202351000000
EU Trial (CTIS) Number:
2023-508759-38-00
Study Contact Information:
(210) 593-5651 or [email protected]
Recruitment on Hold

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Study Summary

To evaluate HDP-102 in patients with Non-Hodgkin lymphoma.

To assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of HDP-102 in patients with relapsed or refractory B-cell malignancies.

To determine the recommended dose for future studies and dose-escalation phase, the study is planned to enter an expansion phase to further evaluate the safety and potential efficacy of HDP-102 at the optimal dose.

Medical Condition
The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.
  • Leukemia
  • Lymphoma, Non-Hodgkin's
    • Phase
    The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
    I
    Sex
    Female & Male
    Age
    18+ years
    Study Drug
  • Drug: Patients will receive HDP-102.
    • Study Status
    Indicates the current recruitment status or the expanded access status
    Recruitment on Hold

    Requirements information
    Inclusion criteria
    • Inclusion Criteria:
    • Patients with Relapsed/Refractory B-cell Blood Cancers, B-cell non-Hodgkin´s lymphoma and B-cell chronic lymphocytic leukaemia

    Clinical Study Information for Healthcare Providers

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    Study Locations

    Location
    Investigator
    Status
    Condition(s) Treated at Site
    Location
    START Madrid, Spain (FJD)
    Madrid, Spain, 28040
    Investigator
    Daniel Morillo Giles
    Status
    Will Be Recruiting
    Condition(s) Treated at Site
    Leukemia
    Lymphoma, Non-Hodgkin's