Non Hodgkin Lymphoma Clinical Trial

A Study of JNJ-90014496 in Participants With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Summary

This is a Phase Ib multicenter, open-label study of C-CAR039, an autologous bi-specific CAR-T therapy targeting CD19 and CD20, for the treatment of adult patients with relapsed or refractory B-Cell non-Hodgkin lymphoma (r/r B-NHL).

View Eligibility Criteria

Eligibility Criteria

Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent
Diagnosis of mature aggressive large B cell non-Hodgkin lymphoma or follicular lymphoma
Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive
Must have relapsed or refractory disease with the following indications for each histologic subtype: Mature aggressive large B cell non-Hodgkin lymphoma (NHL) and follicular lymphoma Grade 3b: Participants must have >= 2 lines of systemic therapy, or >= 1 line of systemic therapy for participants who are ineligible for autologous stem cell transplant; Follicular lymphoma Grade 1-3a and marginal zone lymphoma: Participants must have >= 2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody
Measurable disease as defined by Lugano 2014 classification
Eastern cooperative oncology group (ECOG) performance status of either 0 or 1

Exclusion Criteria

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
Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

104

Study ID:

NCT05421663

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There are 9 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
Colorado Blood Cancer Institute
Denver Colorado, 80218, United States
Rutgers Cancer Institute of New Jersey
Piscataway New Jersey, 08854, United States
St. David's South Austin Medical Center
Austin Texas, 78704, United States
Texas Transplant Institute
San Antonio Texas, 78229, United States
Swedish Cancer Institute
Seattle Washington, 98104, United States
St. Vincent's Hospital Melbourne
Fitzroy , 3065, Australia
The Alfred Hospital
Melbourne , 3004, Australia
Fiona Stanley Hospital
Murdoch , 6150, Australia

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

104

Study ID:

NCT05421663

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.