A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participan

A Study of JNJ-80948543, a T-cell Redirecting CD79b x CD20 x CD3 Trispecific Antibody, in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

Last Updated August 30, 2024

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CR109174

OVERVIEW

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

1
Sites
27 Sites
Status

Recruiting

SUMMARY

The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D[s]), optimal dosing schedule(s) and route(s) of administration 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).

CONDITIONS

Lymphoma, Non-Hodgkin
Leukemia, Lymphocytic, Chronic, B-Cell

ELIGIBILITY

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 or deemed not eligible or fit for an alternative 2nd line therapy. Participants may be eligible if relapsing after chimeric antigen receptors (CAR-T) cell treatment or while waiting for a CAR-T cell treatment.

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): Previously treated with at least 2 lines of systemic therapy. H.pylori-positive gastric MALT lymphoma must have failed prior H. pylori eradication therapy as one of their prior lines .

Waldenstrom macroglobulinemia (WM): Previously treated with at least 1 line of systemic therapy.

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 treatment

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

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 appropr

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DETAILS

LOCATIONS

Locations in:

United States, Australia, China, Denmark, France, Israel, Poland, Japan

Country (8)	City or Province (27)	Status
United States	Duarte City of Hope	RECRUITING
United States	New York Icahn School of Medicine at Mount Sinai	RECRUITING
United States	New York Memorial Sloan Kettering Cancer Center	RECRUITING
United States	Nashville Sarah Cannon Research Institute	COMPLETED
United States	Houston The University of Texas MD Anderson Cancer Center	RECRUITING
United States	San Antonio Texas Transplant Institute	RECRUITING
United States	Seattle Seattle Cancer Care Alliance	RECRUITING
Australia	Macquarie University Macquarie University Hospital	RECRUITING
Australia	Melbourne The Alfred Hospital	RECRUITING
Australia	Nedlands Linear Clinical Research Ltd	RECRUITING
Australia	Randwick Scientia Clinical Research	RECRUITING
China	Guangzhou Sun Yat-Sen University Cancer Center	RECRUITING
China	Tianjin Tianjin cancer hospital	RECRUITING
China	Wuhan Union Hospital Tongji Medical College of Huazhong University of Science and Technology	RECRUITING
Denmark	Copenhagen Rigshospitalet	RECRUITING
Denmark	Odense Odense University Hospital	RECRUITING
France	Lille Cedex CHRU de Lille Hopital Claude Huriez	RECRUITING
France	Paris Institut Curie	RECRUITING
France	Toulouse Cedex 9 Institut Universitaire du cancer de Toulouse-Oncopole	RECRUITING
Israel	Haifa Carmel Medical Center	RECRUITING
Israel	Jerusalem Hadassah Medical Center	RECRUITING
Israel	Tel Aviv Tel Aviv Sourasky Medical Center	RECRUITING
Poland	Gdansk Uniwersyteckie Centrum Kliniczne Osrodek Badan Klinicznych Wczesnych Faz	RECRUITING
Poland	Skorzewo Centrum Medyczne Pratia Poznan	RECRUITING
China	Chongqing Chongqing University Cancer Hospital	RECRUITING
Japan	Nagoya Shi Aichi Cancer Center Hospital	RECRUITING
Japan	Tokyo The Cancer Institute Hospital of JFCR	RECRUITING

Geo Locations

34.13945, -117.97729

40.71427, -74.00597

36.16589, -86.78444

29.76328, -95.36327

29.42412, -98.49363

47.60621, -122.33207

-33.7738237, 151.1126498

-37.814, 144.96332

-31.98184, 115.8073

-33.91439, 151.24895

23.11667, 113.25

39.14222, 117.17667

30.58333, 114.26667

55.67594, 12.56553

55.39594, 10.38831

50.63297, 3.05858

48.85341, 2.3488

43.60426, 1.44367

32.81841, 34.9885

31.76904, 35.21633

32.08088, 34.78057

54.35205, 18.64637

52.3906266, 16.7919124

29.56278, 106.55278

35.18147, 136.90641

35.6895, 139.69171

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.

OVERVIEW

Sexes Eligible for Study

Age

Phase

Sites

Status

SUMMARY

CONDITIONS

ELIGIBILITY

DETAILS

LOCATIONS

34.13945, -117.97729

40.71427, -74.00597

40.71427, -74.00597

36.16589, -86.78444

29.76328, -95.36327

29.42412, -98.49363

47.60621, -122.33207

-33.7738237, 151.1126498

-37.814, 144.96332

-31.98184, 115.8073

-33.91439, 151.24895

23.11667, 113.25

39.14222, 117.17667

30.58333, 114.26667

55.67594, 12.56553

55.39594, 10.38831

50.63297, 3.05858

48.85341, 2.3488

43.60426, 1.44367

32.81841, 34.9885

31.76904, 35.21633

32.08088, 34.78057

54.35205, 18.64637

52.3906266, 16.7919124

29.56278, 106.55278

35.18147, 136.90641

35.6895, 139.69171

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