Trial purpose
Cancer treatment
Tumor type
Haematological
Age
18+
Clinical summary
Summary
This study will assess whether the medication JNJ-90009530 can be used for the treatment of B-cell Non-Hodgkin Lymphoma which has returned, or not responded to treatment.
JNJ-90009530 is a form of CAR-T therapy where the patient's own T cells are used to treat the cancer.
The aim of this study is to see what side effects the medication may have, how long it stays in the body and how the body responds to it.
This phase 1, open label, multi site study will recruit an estimated 92 participants to a single study group.
Conditions
This trial is treating people with B-cell Non-Hodgkin Lymphoma which has returned or not responded to treatment
Eligibility
Exclusion
- Diagnosis of Human herpes virus (HHV) 8-positive Diffuse large B Cell lymphoma (DLBCL)
- Prior allogeneic Hematopoietic stem cell transplantation (HSCT)
- Autologous stem cell transplant within 12 weeks of chimeric antigen receptor (CAR) T cell infusion
- Uncontrolled active infections
- History of deep vein thrombosis or pulmonary embolism within six months of infusion (except for line associated deep vein thrombosis [DVT])
- History of stroke, unstable angina, myocardial infarction, congestive heart failure ( New York Heart Association [NYHA] Class III or IV), severe cardiomyopathy or ventricular arrhythmia requiring medication or mechanical control within 6 months of screening
- History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease or neurodegenerative disorder
- Known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
- Active central nervous system (CNS) involvement by malignancy
- Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)
Inclusion
- You have had treatment, but your cancer has come back (relapsed or recurrent).
- 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 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
Janssen Research & Development, LLC
Scientific Title
A Phase 1b Multicenter, Open-Label, Study of JNJ-90009530, an Autologous Anti-CD20 CAR-T Cell Therapy in Adult Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma
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