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

Last Updated March 13, 2025

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90014496LYM1001

OVERVIEW

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

1
Sites
26 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 B-Cell non-Hodgkin lymphoma (B-NHL).

CONDITIONS

Lymphoma, Non-Hodgkin
Lymphoma, B-Cell

ELIGIBILITY

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 following indications for each subtype: Relapsed or refractory mature aggressive large B cell non-Hodgkin lymphoma (NHL) and follicular lymphoma 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 follicular lymphoma 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 2 or 3 cycles of frontline chemoimmunotherapy. Participants must have only received 2 or 3 cycles of frontline chemoimmunotherapy for DLBCL
* Measurable disease as defined by Lugano 2014 classification
* Eastern cooperative oncology group (ECOG) performance status of either 0 or 1. ECOG of 0 to 2 is allowed in frontline high-risk DLBCL cohort

Exclusion Criteria:

* Diagnosis of Human herpes virus (HHV) 8-positive DLBCL or T cell/histiocyte-rich large B-cell lymphoma
* Any prior solid organ or allogeneic stem cell transplantation
* 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, 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)

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

United States, Australia, Denmark, Netherlands, Spain, United Kingdom, Canada, South Korea

Country (8)	City or Province (26)	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
Canada	Toronto Princess Margaret Cancer Centre University Health Network	RECRUITING
South Korea	Seoul Seoul National University Hospital	RECRUITING
South Korea	Seoul Asan Medical Center	RECRUITING
South Korea	Seoul Samsung Medical Center	RECRUITING
Netherlands	Rotterdam Erasmus MC	RECRUITING
Spain	Barcelona Hosp Univ Vall D Hebron	RECRUITING
Spain	Madrid Hosp Univ Fund Jimenez Diaz	RECRUITING
United Kingdom	Manchester The Christie NHS Foundation Trust Christie Hospital	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

43.70011, -79.4163

37.566, 126.9784

51.9225, 4.47917

41.38879, 2.15899

40.4165, -3.70256

53.48095, -2.23743

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

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Corresponds to individual site.

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