Phase1/2 Study of IPH6501 in Patients With Relapsed /Refr... | NCT06088654

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

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

Expanded Access Info

Start Date

Mar 4, 2024Actual

Primary Completion Date

Feb 6, 2026Actual

Completion Date

Feb 6, 2026Actual

First Submitted Date

Oct 12, 2023

First Submission Date that Met QC Criteria

Oct 12, 2023

First Posted Date

Oct 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 9, 2026

Last Update Posted Date

Apr 14, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Label	Type	Description	Intervention Names
IPH6501 monotherapy	Experimental		Drug: IPH6501

Name	Type	Description	Arm Group Labels	Other Names
IPH6501	Drug	phase 1 (dose finding) and phase 2 (dose expansion)	IPH6501 monotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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)	From time of informed consent through treatment period and including the follow-up: up to 22 months

Secondary Outcomes

Measure	Description	Time Frame
Objective Response Rate (ORR)	To investigate any preliminary antitumor activity	From time of informed consent through treatment period and including the follow-up: up to 22 months
Duration Of Response (DoR)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
City of Hope		Duarte	California	91010	United States
Cedars Sinai

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases
D006425	Hemic and Lymphatic Diseases
D007160	Immunoproliferative Disorders
D007154	Immune System Diseases