RECRUITING

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

Description

This is a Phase 1b/2, 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 (r/r) B-Cell non-Hodgkin lymphoma (B-NHL) or frontline high-risk diffuse large B-cell lymphoma (DLBCL).

Study Overview

Study Details

Study overview

This is a Phase 1b/2, 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 (r/r) B-Cell non-Hodgkin lymphoma (B-NHL) or frontline high-risk diffuse large B-cell lymphoma (DLBCL).

A Phase 1b/2, Multicenter, Open-label, Study of JNJ-90014496, an Autologous CD19/CD20 Bi-specific CAR-T Cell Therapy in Adult Participants With B-cell Non-Hodgkin Lymphoma

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

Condition
Lymphoma, Non-Hodgkin
Intervention / Treatment

-

Contacts and Locations

Duarte

City of Hope, Duarte, California, United States, 91010

Denver

Colorado Blood Cancer Institute, Denver, Colorado, United States, 80218

Iowa City

University of Iowa Hospital and Clinics, Iowa City, Iowa, United States, 52242

Lexington

University of Kentucky Medical Center, Lexington, Kentucky, United States, 40536

Piscataway

Rutgers Cancer Institute of New Jersey, Piscataway, New Jersey, United States, 08854

Charlotte

Levine Cancer Institute, Charlotte, North Carolina, United States, 28001

Cleveland

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States, 44106

Pittsburgh

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania, United States, 15232

Nashville

Sarah Cannon Research Institute, Nashville, Tennessee, United States, 37203

Austin

St. David's South Austin Medical Center, Austin, Texas, United States, 78704

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * 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 following indications for each subtype in Phase 1b: Relapsed or refractory mature aggressive large B cell non-Hodgkin lymphoma (NHL) and follicular lymphoma (FL) Grade 3b: Participants must have had \>= 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); Relapsed or refractory FL Grade 1-3a and marginal zone lymphoma: Participants must have had \>= 2 prior lines of anti-neoplastic systemic therapy. Participants also must have prior exposure to an anti-CD20 monoclonal antibody; Frontline high-risk diffuse large B Cell lymphoma (DLBCL): Participants must have DLBCL or high-grade B-cell lymphoma (HGBCL) with residual lymphoma by positive interim positron emission computed tomography consistent with lymphoma after 2 or 3 cycles of frontline chemoimmunotherapy. Participants must have only received 2 or 3 cycles of frontline chemoimmunotherapy for DLBCL; Phase 2 participants must have following: A diagnosis of Large B-cell lymphoma (LBCL), Follicular large B-cell lymphoma (FLBL), or transformation of indolent lymphoma; Received at least 2 prior lines of systemic therapy including an anthracycline containing chemotherapy regimen and an anti-CD20 monoclonal antibody; 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:
  • * Measurable disease as defined by Lugano 2014 classification
  • * Eastern cooperative oncology group (ECOG) performance status of 0 to 2
  • * 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 Burkitt-like lymphoma or Richter's transformation, Lymphomatoid granulomatosis, Plasmablastic lymphoma
  • * Any prior solid organ or allogeneic stem cell transplantation
  • * Autologous stem cell transplant within 12 weeks of apheresis; CAR-T exposed only: Prior CAR-T cell therapy within 12 weeks of apheresis

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Janssen Research & Development, LLC,

Janssen Research & Development, LLC Clinical Trial, STUDY_DIRECTOR, Janssen Research & Development, LLC

Study Record Dates

2028-12-29