Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma (NCT06088654) | Clinical Trial Compass
TerminatedPhase 1/2
Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma
Stopped: Following Completion of dose escalation, the study has been discontinued as part of the Company's strategic priorization of its pipeline.
United States23 participantsStarted 2024-03-04
Plain-language summary
This is an international, first-in-human, multicenter, open-label Phase 1/2 study to evaluate the safety profile, tolerability of IPH6501, and determine the recommended phase 2 dose (RP2D) for patients with B-Cell non-Hodgkin lymphoma.
Who can participate
Age range18 Years
SexALL
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Main Inclusion criteria
* Patients with advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin's lymphoma (NHL) including the following types defined by WHO 2016: Diffuse Large B Cell Lymphoma (DLBCL); high grade; thymic; Follicular Lymphoma (FL); Mantle cell lymphoma (MCL); Marginal zone lymphoma (MZL)
* Relapsed, progressive and/or refractory disease without established alternative therapy
* Must have received at least 2 prior systemic therapies including at a minimum anti-CD20 antibody therapy (e.g., rituximab) potentially in combination with chemotherapy and/or relapsed after autologous stem cell rescue.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Adequate organ and hematological function
* Able to provide a fresh biopsy from a safely accessible site (or historical biopsy), per investigator determination.
Main Exclusion Criteria
* Patients with another invasive malignancy in the last 2 years
* Prior chemotherapy, immunotherapy or other anti-cancer therapy within less than 4 weeks before study drug administration.
* Autologous stem cell transplant or treatment with CAR-T (Chimeric Antigen Receptor T-Cell) cell therapy within 100 days prior to first dose of study drug
* Subjects with brain or subdural metastases are not eligible, nor those with history of central nervous system (CNS) lymphoma
* Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease.
* Known history of infe…
What they're measuring
1
Safety and tolerability
Timeframe: From time of informed consent through treatment period and including the follow-up: up to 22 months