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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05421663
Other study ID # 90014496LYM1001
Secondary ID 90014496LYM10012
Status Recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05784441 - A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL) Phase 1
Recruiting NCT06173518 - A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukaemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL) Phase 1
Recruiting NCT02981745 - Study of Safety,Efficacy and Pharmacokinetics of CT-1530 in Patients With Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, and Waldenstrom's Macroglobulinemia Phase 1/Phase 2