Study on UCART20x22 for Treating Relapsed or Hard-to-Treat B-Cell Non-Hodgkin Lymphoma
Sponsor: Cellectis S.A.
ClinicalTrials ID:NCT05607420
This clinical trial is testing a new treatment called UCART20x22 for patients with B-Cell Non-Hodgkin Lymphoma that has returned or is not responding to other treatments. The study aims to find the safest and most effective dose of UCART20x22.
Patient Parameters
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Program Overview
This study is the first to test UCART20x22 in humans. It is open-label, meaning both doctors and participants know what treatment is being given. The study will determine the best dose of UCART20x22 for patients with B-Cell Non-Hodgkin Lymphoma (B-NHL) that has come back or is not responding to treatment. The main goals are to assess the safety of UCART20x22 and find the maximum dose that patients can tolerate.
Eligibility Criteria
Inclusion Criteria
- Must have a performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
- Have relapsed or refractory mature B-Cell Non-Hodgkin Lymphoma (B-NHL) that is positive for CD20 and/or CD22 markers.
- Eligible subtypes include:
- For Dose-Finding Part: Relapsed or refractory mature B-NHL, excluding certain types like chronic lymphocytic leukemia and Burkitt's lymphoma.
- For Dose-Expansion Part: Relapsed or refractory large B-cell lymphoma (LBCL), including specific subtypes like diffuse large B-cell lymphoma (DLBCL) and transformed follicular lymphoma.
- Must have tried at least two previous treatments, including specific drugs for different lymphoma types.
- Must have access to autologous stem cells if at high risk for blood-related side effects.
Exclusion Criteria
- Have used an investigational product recently, except for certain cell or gene therapies.
- Have had recent chemotherapy or targeted therapy for B-NHL.
- Have had monoclonal antibody therapy within 30 days.
- Have had recent cell or gene therapy targeting both CD20 and CD22.
- Have had a stem cell transplant recently.
- Have active graft versus host disease or need immunosuppressive treatment.
- Have had recent radiotherapy, except for specific cases.
- Have active or past central nervous system lymphoma.
- Have an active central nervous system disorder.
- Are taking more than 20 mg of prednisone daily.
- Have an active infection or history of certain infections.
- Have a history of allergy to alemtuzumab.
- Have uncontrolled heart disease.
- Have had major surgery recently.
- Have another uncontrolled cancer within the last two years.
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