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TerminatedNCT06088654Updated Apr 14, 2026

Phase1/2 Study of IPH6501 in Patients With Relapsed /Refractory B-Cell Non-Hodgkin Lymphoma

A Phase 1/2 interventional study of IPH6501 in Non Hodgkin Lymphoma, sponsored by Innate Pharma. Terminated at 14 sites in 3 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-14.

Sponsored by Innate Pharma · Phase 1/2, Interventional, and Treatment

Why this study was terminated
Following Completion of dose escalation, the study has been discontinued as part of the Company's strategic priorization of its pipeline.
Phase
Phase 1/2
Study type
Interventional
Enrollment
23
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

In Phase 1 - Dose finding, patients with advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin lymphoma (NHL) will be enrolled. The dose finding part will include 2 sub-parts: Dose escalation will determine the Maximum Tolerated Dose (MTD) or the highest tested dose, Dose assessment will determine RP2D.

In Phase 2 - Dose expansion, one or more cohorts will be selected with patients with subtypes of advanced histologically confirmed, documented CD20+ B-cell non-Hodgkin lymphoma.

02

Conditions studied

  • Non Hodgkin Lymphoma

Keywords

  • ANKET®
  • NK cell engager
  • tetraspecific NK cell engager
03

In context

Lymphoma, Non-Hodgkin

1,989 studies on the registry are indexed under Lymphoma, Non-Hodgkin; 307 are open to participants now.

This study's enrollment of 23 is below the median of 41 across 1,703 interventional studies indexed under Lymphoma, Non-Hodgkin.

Browse Lymphoma, Non-Hodgkin studies →

Lead sponsor

Innate Pharma is the lead sponsor of 17 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
23 participants (actual)

Study arms

  • Experimental
    IPH6501 monotherapy

    Drug: IPH6501

Interventions

  • DrugIPH6501

    phase 1 (dose finding) and phase 2 (dose expansion)

06

What researchers measure

Primary outcomes

  1. Safety and tolerability

    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)

    Time frame: From time of informed consent through treatment period and including the follow-up: up to 22 months

Secondary outcomes

  1. Objective Response Rate (ORR)

    To investigate any preliminary antitumor activity

    Time frame: From time of informed consent through treatment period and including the follow-up: up to 22 months

  2. Duration Of Response (DoR)

    To investigate any preliminary antitumor activity

    Time frame: From time of informed consent through treatment period and including the follow-up: up to 22 months

  3. Progression Free Survival (PFS)

    To investigate any preliminary antitumor activity

    Time frame: From time of informed consent through treatment period and including the follow-up: up to 22 months

  4. Maximum Observed Plasma Concentration (Cmax)

    To characterize and evaluate the pharmacokinetic profile of IPH6501

    Time frame: From time of informed consent through treatment period and including the follow-up: up to 22 months

  5. Area Under the Plasma Concentration (AUC)

    To characterize and evaluate the pharmacokinetic profile of IPH6501

    Time frame: From time of informed consent through treatment period and including the follow-up: up to 22 months

  6. Incidence of antidrug antibodies (ADA) against IPH6501

    To evaluate the immunogenicity of IPH6501

    Time frame: From time of informed consent through treatment period and including the follow-up: up to 22 months

07

Study locations

14 sites
  • City of Hope
    Duarte, California 91010, United States
  • Cedars Sinai
    Los Angeles, California 90048, United States
  • Siteman Cancer Center
    St Louis, Missouri 63110, United States
  • Icahn School Of Medicine At Mount Sinai
    New York, New York 10029, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Wollongong Private Hospital
    Wollongong, New South Wales 2500, Australia
  • Monash Health
    Clayton, Victoria 3168, Australia
  • Peninsula Private Hospital
    Frankston, Victoria 3910, Australia
  • Austin Health
    Heidelberg, Australia
  • Institute Bergonie
    Bordeaux, France
  • Centre Hospitalier Regional Universitaire de Lille
    Lille, France
  • Hospices Civils de Lyon
    Lyon, 69002, France
  • Hôpital de la Coception
    Marseille, 13005, France
  • Centre Hospitalier Universitaire de Nantes
    Nantes, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06088654
Lead sponsor
Innate Pharma
Responsible party
Sponsor
First posted
Oct 18, 2023
Start date
Mar 4, 2024
Primary completion
Feb 6, 2026
Completion
Feb 6, 2026
Last update
Apr 14, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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