Clinical trial · Interventional
Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma
A Phase 1/2, Open-Label, Multicenter Trial Investigating the Safety, Tolerability, and Preliminary Antineoplastic Activity of IPH6501 in Patients With Relapsed and/or Refractory CD20-expressing Non-Hodgkin Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Following Completion of dose escalation, the study has been discontinued as part of the Company's strategic priorization of its pipeline.
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non Hodgkin Lymphoma | Non-Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IPH6501 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IPH6501 monotherapy
- interventionNames
- Drug: IPH6501
Primary outcomes (1)
- measure
- Safety and tolerability
- timeFrame
- From time of informed consent through treatment period and including the follow-up: up to 22 months
- description
- To evaluate the safety profile (including dose limiting toxicities (DLT(s), the maximum tolerated dose (MTD) or highest tested dose), tolerability and determine the recommended phase 2 dose (RP2D)
Secondary outcomes (6)
- measure
- Objective Response Rate (ORR)
- timeFrame
- From time of informed consent through treatment period and including the follow-up: up to 22 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 infection with human immunodeficiency virus (HIV) or hepatitis B or C * Major surgery within 4 weeks before the first dose of study drug * Comorbidities including diabetes, cardiovascular diseases, immunodeficiencies/autoimmune condition * Pregnant / breastfeeding woman
References
Publications (0)
Data not yet available