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

Last Updated February 15, 2025

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90014496LYM1001

OVERVIEW

Sexes Eligible for Study
all
Age
18+ years
Phase
phase 1

1
Sites
18 Sites
Status

Recruiting

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).

CONDITIONS

Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

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)

More...

DETAILS

LOCATIONS

Locations in:

United States, Australia, Denmark, Netherlands, Spain, United Kingdom

Country (6)	City or Province (18)	Status
United States	Duarte City of Hope	RECRUITING
United States	Denver Colorado Blood Cancer Institute	RECRUITING
United States	Piscataway Rutgers Cancer Institute of New Jersey	RECRUITING
United States	Charlotte Levine Cancer Institute	RECRUITING
United States	Pittsburgh University of Pittsburgh Medical Center	RECRUITING
United States	Austin St. David's South Austin Medical Center	RECRUITING
United States	San Antonio Texas Transplant Institute	RECRUITING
United States	Seattle Swedish Cancer Institute	RECRUITING
Australia	Fitzroy St Vincents Hospital Melbourne	RECRUITING
Australia	Melbourne The Alfred Hospital	RECRUITING
Australia	Murdoch Fiona Stanley Hospital	RECRUITING
Australia	Waratah Calvary Mater Newcastle Hospital	RECRUITING
Denmark	Copenhagen Rigshospitalet	RECRUITING
Denmark	Odense Odense University Hospital	RECRUITING
Netherlands	Utrecht UMC Utrecht	RECRUITING
Spain	Barcelona Hosp Clinic de Barcelona	RECRUITING
United Kingdom	London University College London Hospitals	RECRUITING
United States	Iowa City University of Iowa Hospital and Clinics	RECRUITING

Geo Locations

34.13945, -117.97729

39.73915, -104.9847

40.49927, -74.39904

35.22709, -80.84313

40.44062, -79.99589

30.26715, -97.74306

29.42412, -98.49363

47.60621, -122.33207

-37.79839, 144.97833

-37.814, 144.96332

-32.06987, 115.83757

-32.90667, 151.72647

55.67594, 12.56553

55.39594, 10.38831

52.09083, 5.12222

41.38879, 2.15899

51.50853, -0.12574

41.66113, -91.53017

Indicates 50+ sites in this region: click to zoom in.

Indicates 10+ sites in this region: click to zoom in.

Indicates < 10 sites in this region: click to zoom in.

Corresponds to individual site.

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