Non Hodgkin Lymphoma Clinical Trial

A Study of JNJ-80948543, a T Cell Redirecting Antibody, in Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

Summary

The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]) and optimal dosing schedule(s) of JNJ-80948543 in Part A (Dose Escalation) and to further characterize the safety of JNJ-80948543 at the putative RP2D(s) in Part B (Cohort Expansion).

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Full Description

B-cell non-Hodgkin lymphoid malignancies (NHLs) are defined by clonal populations of B- lymphocytes. JNJ-80948543 is a T-cell redirecting tri-specific antibody that recognizes the cluster of differentiation 3 (CD3) antigen on T lymphocytes and surface antigens on mature healthy and malignant B- lymphocytes. The study will be conducted in 2 parts: Part A (dose Escalation) and part B (Cohort Expansion). Each of the 2 parts of this study is divided into 3 periods, a screening phase, a treatment phase and a post-treatment follow-up phase. The total duration of the study will be up to 2 year 5 months. Efficacy assessments will include radiographic image assessments, positron emission tomography scan, bone marrow assessment, endoscopy, physical examinations. Safety will be monitored throughout the study.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Histologic documentation of disease: B-cell non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL) requiring therapy.

All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment.

B-cell NHL as defined per the 2016 world health organization (WHO) classification. In addition, the following disease-specific criteria outlined below must be met.

If diffuse large B-cell lymphoma (DLBCL) or other high-Grade B-cell lymphoma: Received, or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent.

If transformed lymphoma from low Grade B-cell malignancies: Received or not a candidate for an approved first-line regimen for DLBCL and received or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent. If follicular lymphoma (FL) (all grades): Previously treated with a minimum of 2 prior lines of systemic therapy, with at least one prior line containing an anti-CD20 antibody.

If mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) (including nodal, extranodal/MALT, and splenic MZL subtypes), or Waldenstrom macroglobulinemia (WM): Previously treated with at least 1 line of systemic therapy. H.pylori-positive gastric MALT lymphoma must have failed prior H. pylori eradication therapy as one of their prior lines.

small lymphocytic lymphoma/chronic lymphocytic leukemia (CLL/SLL): Relapsed or refractory with at least 2 prior lines of therapy, including a Bruton tyrosine kinase inhibitor (BTK) inhibitor or a BCL2 inhibitor, if eligible. In addition for part B Participants must have measurable disease as defined by the appropriate disease response criteria

Eastern Cooperative Oncology Group (ECOG) performance status Grade of 0 or 1
Cardiac parameters within the following range: corrected QT interval (QTc intervals corrected using Fridericia's formula [QTcF]) less than or equal to (<=) 480 milliseconds based on the average of triplicate assessments performed no more than 5 (plus minus [+-] 3) minutes apart
A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (beta- human chorionic gonadotropin) at screening and must agree to further serum or urine pregnancy tests prior to the first dose, during the study and until 3 months after the last dose of study treatment
A female participant must agree not to be pregnant, breastfeeding, or planning to become pregnant while enrolled in this study or within 3 months after the last dose of study intervention

Exclusion Criteria:

Known active central nervous system (CNS) involvement; Lymphoma with CNS involvement may be allowed in pharmacokinetic/ pharmacodynamic (PK/PD) and expansion cohorts if approved by the study evaluation team (SET)
Prior solid-organ transplantation
Autoimmune or inflammatory disease requiring systemic steroids or other immunosuppressive agents (example, methotrexate or tacrolimus) within 1 year prior to first dose of study drug
Toxicity from prior anticancer therapy has not resolved to baseline levels or to Grade <= 1 (except alopecia, vitiligo, peripheral neuropathy, or endocrinopathies that are stable on hormone replacement, which may be Grade 2)
Clinically significant pulmonary compromise, particularly the need for supplemental oxygen use to maintain adequate oxygenation

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

180

Study ID:

NCT05424822

Recruitment Status:

Recruiting

Sponsor:

Janssen Research & Development, LLC

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There are 22 Locations for this study

See Locations Near You

City of Hope
Duarte California, 91010, United States
Icahn School of Medicine at Mt. Sinai
New York New York, 10029, United States
Memorial Sloan Kettering Cancer Center
New York New York, 10065, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
The University of Texas MD Anderson Cancer Center
Houston Texas, 77030, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Macquarie University Hospital
Macquarie University , 2109, Australia
The Alfred Hospital
Melbourne , 3004, Australia
Linear Clinical Research Ltd
Nedlands , 6009, Australia
Scientia Clinical Research
Randwick , 2031, Australia
Rigshospitalet
Copenhagen , 2100, Denmark
Odense University Hospital
Odense , 5000, Denmark
CHRU de Lille - Hôpital Claude Huriez
Lille Cedex , 59037, France
Hopital Saint Eloi
Montpellier Cedex 5 , 34285, France
Institut Curie
Paris , 75005, France
Institut Universitaire du cancer de Toulouse-Oncopole
Toulouse Cedex 9 , 31059, France
Gustave Roussy
Villejuif , 94800, France
Carmel Medical Center
Haifa , 34362, Israel
Hadassah Medical Center
Jerusalem , 91120, Israel
Tel Aviv Sourasky Medical Center
Tel Aviv , 64239, Israel
Uniwersyteckie Centrum Kliniczne, Osrodek Badan Klinicznych Wczesnych Faz
Gdansk , 80-21, Poland
Centrum Medyczne Pratia Poznan
Skorzewo , 60-18, Poland

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 1

Estimated Enrollment:

180

Study ID:

NCT05424822

Recruitment Status:

Recruiting

Sponsor:


Janssen Research & Development, LLC

How clear is this clinincal trial information?

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