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Non Hodgkin LymphomaPhase 1/2NCT06088654

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

A Phase 1/2 study testing IPH6501 in people with Non Hodgkin Lymphoma, run by Innate Pharma at 14 sites in 3 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Hodgkin Lymphoma
What is being tested?
IPH6501
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
14 sitesin 3 countries
Study dates
4 Mar 2024to 6 Feb 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

14 sites in 3 countries.

14 sites in 3 countries

United States5 sites

  • City of Hope

    Duarte, California, 91010

  • Cedars Sinai

    Los Angeles, California, 90048

  • Icahn School Of Medicine At Mount Sinai

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Siteman Cancer Center

    St Louis, Missouri, 63110

Other trials in United States

France5 sites

  • Institute Bergonie

    Bordeaux

  • Centre Hospitalier Regional Universitaire de Lille

    Lille

  • Hospices Civils de Lyon

    Lyon, 69002

  • Hôpital de la Coception

    Marseille, 13005

  • Centre Hospitalier Universitaire de Nantes

    Nantes

Other trials in France

Australia4 sites

  • Monash Health

    Clayton, Victoria, 3168

  • Peninsula Private Hospital

    Frankston, Victoria, 3910

  • Austin Health

    Heidelberg

  • Wollongong Private Hospital

    Wollongong, New South Wales, 2500

Other trials in Australia

About this study

Official title: 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

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.

Being tested
IPH6501
Keywords
ANKET®, NK cell engager, tetraspecific NK cell engager
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPH6501Drug

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

Study groups in NCT06088654
Study groupRoleWhat they receive
IPH6501 monotherapyExperimentalNot described
Receives: Drug: IPH6501

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

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

Secondary outcomes (6)

  1. Objective Response Rate (ORR)

    To investigate any preliminary antitumor activity

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2023
  2. Study start4 Mar 2024
  3. Primary completion6 Feb 2026
  4. Study completion6 Feb 2026

Why it stopped: Following Completion of dose escalation, the study has been discontinued as part of the Company's strategic priorization of its pipeline.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06088654
Sponsor's protocol ID
IPH6501-101
Status last verified
Apr 2026
First submitted
12 Oct 2023
Last updated
14 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IPH6501 in people with Non Hodgkin Lymphoma, run by Innate Pharma at 14 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in United States, France, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Following Completion of dose escalation, the study has been discontinued as part of the Company's strategic priorization of its pipeline.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: From time of informed consent through treatment period and including the follow-up: up to 22 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06088654.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2026.

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