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Purpose

This is a Phase 1b/2, multicenter, open-label, study of prizloncabtagene autoleucel (prizlo-cel), 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

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion 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 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

Exclusion Criteria

  • 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

Study Design

Phase
Phase 1/Phase 2
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Prizlo-Cel 		Participants will receive intravenous (IV) infusion of autologous prizlo-cel.
  • Biological: Prizloncabtagene autoleucel (Prizlo-Cel)
    Prizlo-Cel, an autologous dual targeting chimeric antigen receptor (CAR) - T cell therapy targeting Cluster of differentiation (CD)20 and CD19.
    Other names:
    • JNJ-90014496

Recruiting Locations

City of Hope
Duarte, California 91010

Colorado Blood Cancer Institute
Denver, Colorado 80218

University of Iowa Hospital and Clinics
Iowa City, Iowa 52242

University of Kentucky Medical Center
Lexington, Kentucky 40536

Rutgers Cancer Institute of New Jersey
Piscataway, New Jersey 08854

Levine Cancer Institute
Charlotte, North Carolina 28001

University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106

University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15232

Greco Hainesworth Tennessee Oncology Centers for Research
Nashville, Tennessee 37203

Sarah Cannon Research Institute
Nashville, Tennessee 37203

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

MD Anderson Cancer Center
Houston, Texas 77030

Texas Transplant Institute
San Antonio, Texas 78229

Swedish Cancer Institute
Seattle, Washington 98104

More Details

NCT ID
NCT05421663
Status
Recruiting
Sponsor
Janssen Research & Development, LLC

Study Contact

Study Contact, M.D.
844-434-4210
Participate-In-This-Study1@its.jnj.com

Notice

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