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

Phase 1/2

Recruiting

• Conditions: Relapsed and/or Refractory CD20-expressing Non-Hodgkin Lymphoma
• Interventions: Drug: IPH6501

• Registration Number: 2023-506976-28-00
• Lead Sponsor: Innate Pharma

Brief Summary

To evaluate the safety profile (including dose limiting toxicities (DLT(s), the maximum tolerated dose (MTD) or highest tested dose), tolerability according to National Cancer Institute-Common Terminology Criteria for Adverse Event v5.00 (NCI-CTCAE), and determine the recommended phase 2 dose (RP2D) of IPH6501

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.

Study Timeline

• Study First Posted: 2024-03-25
• Last Update Posted: 2025-04-07

Recruitment & Eligibility

• Status: Ongoing, recruiting
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

Phase 1- Dose finding 1. 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) NOS (Not otherwise specified) • High-grade B-cell lymphoma NOS • Primary mediastinal (thymic) large B-cell lymphoma • Follicular Lymphoma (FL) • Mantle cell lymphoma (MCL) • Marginal zone lymphoma (MZL) (nodal, extranodal or splenic) For the patients with indolent forms of NHL (i.e., FL, MZL) patients must meet criteria to receive systemic therapy

Phase 2- Dose expansion 2. Patients with advanced histologically confirmed, documented CD20+ B-cell NHL defined by WHO 2016.

3. Relapsed, progressive and/or refractory disease without established alternative therapy

4. 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.

5. Male or Female, at least 18 years of age

6. Measurable disease defined as at least one bi-dimensionally measurable nodal lesion, defined as > 1.5 cm in its longest dimension, or at least one bi-dimensionally measurable extranodal lesion, defined as > 1.0 cm in its longest dimension

7. Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

8. Must have a life expectancy of at least 12 weeks.

9. Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non- significant toxicities such as alopecia)

Exclusion Criteria

1. Patients with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the Investigator to be of low likelihood for recurrence)

2. Major surgery within 4 weeks before the first dose of study drug or minor surgery within 1 week (subject must also have recovered from any surgery related toxicities to less than CTCAE Grade 2)

3. Prior chemotherapy, immunotherapy (tumor vaccine, cytokine or growth factor given to control the cancer) or other anti-cancer therapy within less than 4 weeks before study drug administration.

4. 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

5. Live vaccine ≤ 6 weeks prior to first dose of study drug

6. Use of other investigational drugs within 28 days

7. Subjects with brain or subdural metastases are not eligible unless the metastases are asymptomatic and do not require treatment or have been adequately treated by local therapy and have discontinued the use of corticosteroids for this indication for at least 4 weeks prior to study entry. In this protocol subjects with active brain metastasis are not eligible

8. Current or past history of central nervous system (CNS) lymphoma

9. Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease. Patients with a past history of stroke that have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits are allowed

10. Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti‐HCV positive)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IPH6501 monotherapy	IPH6501	-

Primary Outcome Measures

Name	Time	Method
MTD or highest tested dose evaluation		MTD or highest tested dose evaluation
Safety and tolerability analysis		Safety and tolerability analysis

Secondary Outcome Measures

Name	Time	Method
Efficacy analysis		Efficacy analysis
Pharmacokinetics and Immunogenicity analysis		Pharmacokinetics and Immunogenicity analysis

Trial Locations

Locations (6)

Institut Paoli Calmettes; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire De Lille; 🇫🇷 Lille Cedex, France

Centre Hospitalier Universitaire De Nantes; 🇫🇷 Nantes, France

Institut Des Neurosciences De La Timone; 🇫🇷 Marseille, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre Benite, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Institut Paoli Calmettes

🇫🇷Marseille, France

Gabriel BRISOU

Site contact

+33491223866

brisoug@ipc.unicancer.fr