A Study of JNJ-90009530 in Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (r/r B-NHL)

Last Updated August 15, 2024

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90009530LYM1001

OVERVIEW

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

1
Sites
15 Sites
Status

Recruiting

SUMMARY

This is a Phase 1b multicenter, open-label study of JNJ-90009530, an autologous anti-Cluster of differentiation (CD) 20 Chimeric Antigen Receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory B cell non-Hodgkin lymphoma (r/r B-NHL). This trial will employ the Bayesian optimal interval (BOIN) design to determine the recommended Phase 2 dose (RP2D).

CONDITIONS

Relapsed or Refractory B Cell Non-Hodgkin Lymphoma

ELIGIBILITY

Key Inclusion Criteria

* Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent
* All participants must have relapsed or refractory disease for each histologic subtype

* Mature aggressive large B cell NHL and Follicular Lymphoma Grade 3b: Participants must have >= 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). Participants also must have had exposure to an anthracycline and an anti-CD20 targeted agent
* 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
* Tumor must be cluster of differentiation (CD) 20 positive
* Measurable disease as defined by Lugano 2014 classification
* Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1

Key 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
* Active central nervous system (CNS) involvement by malignancy
* Current active liver or biliary disease (except for Gilbert's syndrome or asymptomatic gallstones)

Key Inclusion Criteria

* Participant must be greater than or equal to (>=) 18 years of age, at the time of signing informed consent
* All participants must have relapsed or refractory disease for each histologic subtype

* Mature aggressive large B cell NHL and Follicular

More...

DETAILS

LOCATIONS

Locations in:

United States, Australia, Israel, United Kingdom

Country (4)	City or Province (15)	Status
United States	Iowa City University of Iowa Hospital	RECRUITING
United States	Lexington University of Kentucky	RECRUITING
United States	New Brunswick Rutgers University	RECRUITING
United States	Cleveland University Hospitals Cleveland Medical Center	RECRUITING
United States	Philadelphia University of Pennsylvania	RECRUITING
United States	Houston MD Anderson Cancer Center	RECRUITING
Australia	Camperdown Royal Prince Alfred Hospital	RECRUITING
Australia	Clayton Monash Medical Centre	RECRUITING
Australia	Heidelberg Austin Hospital	RECRUITING
Australia	Herston Royal Brisbane and Women's Hospital	RECRUITING
Australia	Westmead Westmead Hospital	RECRUITING
Israel	Jerusalem Hadassah Medical Center	RECRUITING
Israel	Ramat Gan Sheba Medical Center	RECRUITING
United Kingdom	London University College London Hospitals	RECRUITING
United States	Rochester Mayo Clinic Rochester	RECRUITING

Geo Locations

41.66113, -91.53017

37.98869, -84.47772

40.48622, -74.45182

41.4995, -81.69541

39.95233, -75.16379

29.76328, -95.36327

-33.88965, 151.17642

-37.91667, 145.11667

-37.75, 145.06667

-27.44453, 153.01852

-33.80383, 150.98768

31.76904, 35.21633

32.08227, 34.81065

51.50853, -0.12574

44.02163, -92.4699

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