NCT05421663 A Study of JNJ-90014496 in Participants With B-Cell Non-Hodgkin Lymphoma
| NCT ID | NCT05421663 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Janssen Research & Development, LLC |
| Condition | Lymphoma, Non-Hodgkin |
| Study Type | INTERVENTIONAL |
| Enrollment | 439 participants |
| Start Date | 2022-08-12 |
| Primary Completion | 2028-12-29 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 439 participants in total. It began in 2022-08-12 with a primary completion date of 2028-12-29.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
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
Contact & Investigator
Janssen Research & Development, LLC Clinical Trial
STUDY DIRECTOR
Janssen Research & Development, LLC
Frequently Asked Questions
Who can join the NCT05421663 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lymphoma, Non-Hodgkin. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05421663 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05421663 currently recruiting?
Yes, NCT05421663 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT05421663 trial being conducted?
This trial is being conducted at Duarte, United States, Denver, United States, Iowa City, United States, Lexington, United States and 11 additional locations.
Who is sponsoring the NCT05421663 clinical trial?
NCT05421663 is sponsored by Janssen Research & Development, LLC. The principal investigator is Janssen Research & Development, LLC Clinical Trial at Janssen Research & Development, LLC. The trial plans to enroll 439 participants.