A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)

Relapsed or Refractory B Cell Non-Hodgkin Lymphoma Clinical Trial

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05784441
• Other study ID #: 90009530LYM1001
• Secondary ID: 2023-506259-97-0
• Status: Recruiting
• Phase: Phase 1
• Start date: November 6, 2023
• Est. completion date: May 31, 2027

Study information

• Verified date: June 2024
• Source: Janssen Research & Development, LLC
• Contact: Study Contact
• Phone: 844-434-4210
• Email: Participate-In-This-Study[@]its.jnj.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this multicenter study is to test JNJ-90009530 in Relapsed or Refractory Non-Hodgkin Lymphoma Patients. The main questions the study aims to answer are:

• can a safe dose of JNJ-90009530 be determined that is safe and well tolerated by patients.

• will JNJ-90009530 help patients achieve a response and for how long?

Description:

This is a Phase 1b multicenter, open-label study of JNJ-90009530, an autologous anti-Cluster of differentiation (CD) 20 Chimeric Antigen Receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL).

This trial will employ the Bayesian optimal interval (BOIN) design to determine the recommended Phase 2 dose (RP2D).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 92
• Est. completion date: May 31, 2027
• Est. primary completion date: April 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Key Inclusion Criteria

• Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent

• All participants must have relapsed or refractory disease for each histologic subtype

• Mature aggressive large B cell NHL and Follicular Lymphoma Grade 3b: Participants must have >= 2 lines of systemic therapy or >=1 line of systemic therapy in case of participants ineligible for high-dose chemotherapy and autologous Hematopoietic stem cell transplantation (HSCT). Participants also must have had exposure to an anthracycline and an anti-CD20 targeted agent

• 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

• Tumor must be cluster of differentiation (CD) 20 positive

• Measurable disease as defined by Lugano 2014 classification

• Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1

Key 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

• Active central nervous system (CNS) involvement by malignancy

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Non-Hodgkin
• Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

Intervention

Drug:
• JNJ-90009530
JNJ-90009530, an autologous Chimeric Antigen Receptor (CAR) - T therapy targeting CD20

Locations

Country	Name	City	State
Australia	Royal Prince Alfred Hospital	Camperdown
Australia	Monash Medical Centre	Clayton
Australia	Austin Hospital	Heidelberg
Australia	Royal Brisbane and Women's Hospital	Herston
Australia	Westmead Hospital	Westmead
Israel	Hadassah Medical Center	Jerusalem
Israel	Sheba Medical Center	Ramat Gan
United Kingdom	University College London Hospitals	London
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa Hospital	Iowa City	Iowa
United States	University of Kentucky	Lexington	Kentucky
United States	Rutgers University	New Brunswick	New Jersey
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Israel,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Calculate the Occurence of Adverse Events	The safety and tolerability will be measured by recording the occurence and severity of all adverse events or dose limiting toxicities that occur according to Common Terminology Criteria for Adverse Events (CTCAE) criteria version 5.0	up to 24 months
Primary	Determine Recommended Phase 2 dose (RP2D)	Employ a Bayesian optimal interval (BOIN) design and determine the RP2D with review of the number of dose-limiting toxicities	up to 24 months
Secondary	Determine the Overall Response (OR)	Record the number of subjects who have a complete response (CR) or partial response (PR) by radiographical assessment using Lugano Criteria 2014	up to 24 months
Secondary	Determine the time to response (TTR)	Record the number of days from the date of JNJ-90009530 infusion to a CR or PR	up to 24 months
Secondary	Determine the duration of response (DOR)	Record the number of days from the date of the first CR or PR to relapse or death.	up to 24 months
Secondary	Measure the amount of JNJ-90009530 in blood over time	Review pharmacokinetics (PK) of JNJ-90009530 by measuring the Chimeric Antigen Receptor (CAR) copy number over time by Quantitative polymerase chain reaction (qPCR).	up to 24 months