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

Relapsed or Refractory B Cell Non-Hodgkin Lymphoma Clinical Trial

Official title:

A Phase Ib Multicenter, Open-Label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific 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: NCT05421663
• Other study ID #: 90014496LYM1001
• Secondary ID: 90014496LYM10012
• Status: Recruiting
• Phase: Phase 1
• Start date: August 12, 2022
• Est. completion date: October 28, 2028

Study information

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

Clinical Trial Summary

This is a Phase Ib multicenter, open-label study of JNJ-90014496, an autologous bi-specific chimeric antigen receptor (CAR) T-cell therapy, targeting both cluster of differentiation (CD) CD19 and CD20 for the treatment of adult participants with relapsed or refractory B-Cell non-Hodgkin lymphoma (r/r B-NHL).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: October 28, 2028
• Est. primary completion date: May 29, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

• 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)

Related Conditions & MeSH terms

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

Intervention

Biological:
• JNJ-90014496
JNJ-90014496, an autologous bi-specific chimeric antigen receptor (CAR) - T cell therapy targeting Cluster of differentiation (CD)19 and CD20.

Locations

Country	Name	City	State
Australia	St Vincents Hospital Melbourne	Fitzroy
Australia	The Alfred Hospital	Melbourne
Australia	Fiona Stanley Hospital	Murdoch
Australia	Calvary Mater Newcastle Hospital	Waratah
Denmark	Rigshospitalet	Copenhagen
Denmark	Odense University Hospital	Odense
United States	St. David's South Austin Medical Center	Austin	Texas
United States	Levine Cancer Institute	Charlotte	North Carolina
United States	Colorado Blood Cancer Institute	Denver	Colorado
United States	City of Hope	Duarte	California
United States	Rutgers Cancer Institute of New Jersey	Piscataway	New Jersey
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Texas Transplant Institute	San Antonio	Texas
United States	Swedish Cancer Institute	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Countries where clinical trial is conducted

United States,  Australia,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of Adverse Events (AEs) [Safety and Tolerability]	Occurrence of any AEs, including dose limiting toxicities (DLTs).	Up to 24 months
Primary	Determination of the Recommended Phase 2 Dose (RP2D) of JNJ-90014496 in Participants with Relapsed or Refractory B-cell non-Hodgkin lymphoma (B-NHL)	Based on the assessment of DLTs rates and overall safety profile.	Up to 24 months
Secondary	Overall Response (OR)	Complete response (CR) and partial response (PR) will be assessed by Lugano 2014 guidelines.	Up to 24 months
Secondary	Time to Response (TTR)	The time from the date of JNJ-90014496 infusion to the first documented CR or PR will be assessed by Lugano 2014 guidelines.	Up to 24 months
Secondary	Duration of Response (DOR)	The time from the first documented CR or PR to relapse or death, whichever occurs first will be assessed by Lugano 2014 guidelines.	Up to 24 months
Secondary	Pharmacokinetic Evaluation of JNJ-90014496	JNJ-90014496 blood levels will be reported.	Up to 24 months