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

NCT05421663 | Active Not Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: 90014496LYM10012023-506267-33-00
• Study Type: interventional
• Target: 166
• Locations: 8 countries
• Sites: 32

Brief Summary

This is a Phase 1b/2, multicenter, open-label, study of JNJ-90014496, an autologous dual targeting chimeric antigen receptor (CAR) T-cell therapy targeting both cluster of differentiation (CD) CD20 and CD19, for the treatment of adult participants with relapsed or refractory (r/r) B-Cell non-Hodgkin lymphoma (B-NHL) or frontline high-risk diffuse large B-cell lymphoma (DLBCL).

Conditions

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma, Large B-Cell, Diffuse

Keywords

CD20/CD19

Outcome Measures

Primary Outcomes (2)

• Phase 1b: Occurrence of Adverse Events (AEs) [Safety and Tolerability]

  Occurrence of any AEs, including dose limiting toxicities (DLTs).

  Up to 15 Years post JNJ-90014496 infusion

• Phase 2: Overall Response (OR) As Assessed by Independent Review Committee (IRC)

  Overall response is defined as a PR or CR at any point between the time of JNJ-90014496 infusion until PD or start of subsequent anti-lymphoma therapy, whichever occurs first (per Lugano 2014 guidelines).

  Up to 6 months post last participant's JNJ-90014496 infusion

Secondary Outcomes (12)

• Phase 1b: Overall Response (OR)

  Up to 6 months post last participant's JNJ-90014496 infusion

• Phase 1b: Duration of Response (DOR)

  Up to 6 months post last participant's JNJ-90014496 infusion

• Phase 1b: Pharmacokinetic Evaluation of JNJ-90014496

  Up to 6 months post last participant's JNJ-90014496 infusion

• Phase 2: Occurrence of Adverse Events (AEs) by Severity

  Up to 15 Years post JNJ-90014496 infusion

• Phase 2: Complete Response (CR)

  Up to 6 months post last participant's JNJ-90014496 infusion

Study Arms (1)

JNJ-90014496

EXPERIMENTAL

Participants will receive intravenous (IV) infusion of autologous JNJ-90014496. The study is no longer enrolling.

Biological: JNJ-90014496

Interventions

JNJ-90014496 BIOLOGICAL

JNJ-90014496, an autologous dual targeting chimeric antigen receptor (CAR) - T cell therapy targeting Cluster of differentiation (CD)20 and CD19.

JNJ-90014496

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant must be greater than or equal to (\>=) 18 years of age, at the time of signing informed consent
• Tumor must be histologically confirmed cluster of differentiation (CD)19 and/or CD20 positive
• Must meet the indications for each subtype in Phase 1b as specified in protocol and Phase 2 participants must have following: Diagnosis of Large B-cell lymphoma (LBCL), Follicular large B-cell lymphoma (FLBCL), or transformation of indolent lymphoma; Received at least 2 prior lines of systemic therapy; Relapsed or refractory disease defined as 1 or more of the following: Stable disease or Progressive disease (PD) as best response to most recent anti-lymphoma therapy OR disease progression or recurrence after a partial response (PR) or complete response (CR) to most recent anti lymphoma therapy; cohort specific requirements as mentioned in protocol
• Measurable disease as defined by Lugano 2014 classification
• Eastern cooperative oncology group (ECOG) performance status of 0 to 2

You may not qualify if:

• History of symptomatic deep vein thrombosis or pulmonary embolism within six months of apheresis (line associated deep vein thrombosis is allowed)
• 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 apheresis
• History of a seizure disorder, 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)
• Evidence of active viral or bacterial infection requiring systemic antimicrobial therapy, or uncontrolled systemic fungal infection
• Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-rich large B-cell lymphoma or Burkitt and high-grade B-cell lymphoma with 11q aberrations (previously Burkitt-like lymphoma) or Richter's transformation or Lymphomatoid granulomatosis or Plasmablastic lymphoma or Waldenstrom's Macroglobulinemia
• Any prior solid organ or allogeneic stem cell transplantation
• Autologous stem cell transplant within 12 weeks of apheresis; Prior CAR-T cell therapy within 12 weeks of apheresis

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (32)

City of Hope

Duarte, California, 91010, United States

Location

Colorado Blood Cancer Institute

Denver, Colorado, 80218, United States

Location

University of Iowa Hospital and Clinics

Iowa City, Iowa, 52242, United States

Location

University of Kentucky Medical Center

Lexington, Kentucky, 40536, United States

Location

Rutgers Cancer Institute of New Jersey

Piscataway, New Jersey, 08854, United States

Location

Levine Cancer Institute

Charlotte, North Carolina, 28001, United States

Location

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Greco Hainesworth Tennessee Oncology Centers for Research

Nashville, Tennessee, 37203, United States

Location

Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

St. David's South Austin Medical Center

Austin, Texas, 78704, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Texas Transplant Institute

San Antonio, Texas, 78229, United States

Location

Swedish Cancer Institute

Seattle, Washington, 98104, United States

Location

St Vincents Hospital Melbourne

Fitzroy, 3065, Australia

Location

The Alfred Hospital

Melbourne, 3004, Australia

Location

Fiona Stanley Hospital

Murdoch, 6150, Australia

Location

Calvary Mater Newcastle Hospital

Waratah, 2298, Australia

Location

Princess Margaret Cancer Centre University Health Network

Toronto, Ontario, M5G2M9, Canada

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Odense University Hospital

Odense, 5000, Denmark

Location

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Asan Medical Center

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Hosp Univ Vall D Hebron

Barcelona, 08035, Spain

Location

Hosp Clinic de Barcelona

Barcelona, 08036, Spain

Location

ICO L'Hospitalet - Hospital Duran i Reynals

Barcelona, 08908, Spain

Location

Hosp Univ Fund Jimenez Diaz

Madrid, 28040, Spain

Location

University College London Hospitals

London, NW1 2BU, United Kingdom

Location

The Christie NHS Foundation Trust Christie Hospital

Manchester, M20 4BX, United Kingdom

Location

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 16, 2022
• Study Start: August 12, 2022
• Primary Completion (Estimated): December 29, 2028
• Study Completion (Estimated): July 30, 2041
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

AU (4); DK (2); GB (2); US (14); NL (2); ES (4); CA (1); KR (3)