Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This study has two phases.
In Phase 1 (Dose Finding), people with advanced CD20+ B-cell non-Hodgkin lymphoma (NHL) will be enrolled. This Phase will have 2 sub-parts: Dose Escalation will determine the Maximum Toelrated Dose (MTD) or the highest tested dose, and Dose Assessment will determine the recommended pahse 2 dose (RP2D).
In Phase 2 (Dose Expansion), one or more cohorts will be selected with participants with subtypes of advanced CD20+ B-cell non-Hodgkin lymphoma.
Please note, Austin Health is currently only recruiting people with diffuse large B-cell lymphoma (DLBCL), follicular lymphoma (FL), primary mediastinal large B-cell lymphoma (PMBCL) and Mantle Cell Lymphoma (MCL).
Conditions
This trial is treating people with B-cell non-Hodgkin lymphoma, including the following types: high grade; thymic; Follicular Lymphoma; Mantle Cell Lymphoma; Primary mediastinal large B-cell lymphoma, and Marginal Zone Lymphoma
Eligibility
Inclusion
- 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.
Exclusion
- 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
Inclusion
- Your cancer has spread to other parts of the body (metastatic) or has grown into nearby parts of the body (locally advanced).
- You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
- You have had a certain type of treatment or surgical procedure.
Exclusion
- You have been diagnosed with a prior or secondary type of cancer.
- You have certain types of non-cancer medical conditions.
- You have had certain treatments, surgical procedures or drugs.
Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.
More information
Trial Identifiers
Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:
Trial sponsor
Innate Pharma
Scientific 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
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