A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin

A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer

Last Updated August 28, 2024

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87801493LYM1001

OVERVIEW

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

1
Sites
11 Sites
Status

Recruiting

SUMMARY

The purpose of this study is to characterize safety and to determine the recommended phase 2 regimen (RP2R) for JNJ-87801493 in combination with T-cell engagers (TCEs) [Part A: Dose Escalation] and to further assess the safety of JNJ-87801493 at the RP2R in combination with TCEs [Part B: Dose Expansion].

CONDITIONS

Lymphoma, Non-Hodgkin

ELIGIBILITY

Inclusion Criteria:

* Histologic documentation of B-cell NHL. All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment
* Part 1 participants must have evaluable or measurable disease and Part 2 participants must have measurable disease;all as defined by the appropriate disease response criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Hematologic laboratory parameters must meet the required criterias and the values must be without a transfusion or growth factors for at least 7 days prior to the first dose of study drug
* Participants of childbearing potential must have a negative highly sensitive serum pregnancy test (beta (β)-human chorionic gonadotropin) at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.

Exclusion Criteria:

* Known active central nervous system involvement (CNS) or leptomeningeal involvement. CNS involvement may be allowed in specific cohorts as determined by the Study Evaluation Team (SET)
* Prior solid-organ transplantation
* Prior treatment with JNJ-80948543 and/or JNJ-75348780. In addition, history of known allergies, hypersensitivity, or intolerance to either JNJ-80948543, JNJ-75348780, or JNJ-87801493 or its excipients
* Chemotherapy, targeted therapy, or immunotherapy within 14 days before the first dose of study treatment. For investigational agents where the half-life is known, there should be a treatment-free window of at least 2 weeks or 5 half-lives. For checkpoint blockade therapy (example, anti-programmed cell death protein-1 [anti-PD-1]), a washout period of up to 6 weeks may be considered
* Malignancy diagnosis other than the disease under study within 1 year prior to screening. Exceptions are squamous and basal cell carcinoma of the skin, carcinoma in situ of the cervix and any malignancy that is considered cured or has minimal risk of recurrence within 1 year of first dose of the study drugs in the opinion of both the investigator and sponsor's medical monitor
* Autoimmune or inflammatory disease requiring systemic corticosteroids or other immunosuppressive agents within 1 year prior to first dose of study treatment
* Evidence of active viral, bacterial, or uncontrolled systemic fungal infection requiring systemic treatment within 7 days before the first dose of study treatment
* Abnormal cardiac function

Inclusion Criteria:

More...

DETAILS

LOCATIONS

Locations in:

Australia, Denmark, Israel, Spain

Country (4)	City or Province (11)	Status
Australia	Melbourne The Alfred Hospital	RECRUITING
Australia	Nedlands Linear Clinical Research Ltd	RECRUITING
Australia	Randwick Scientia Clinical Research	RECRUITING
Denmark	Copenhagen Rigshospitalet	RECRUITING
Denmark	Odense Odense University Hospital	RECRUITING
Israel	Jerusalem Hadassah Medical Center	RECRUITING
Israel	Tel Aviv Sourasky (Ichilov) Medical Center	RECRUITING
Spain	Barcelona Hosp. Univ. Vall D Hebron	RECRUITING
Spain	Madrid Hosp Univ Fund Jimenez Diaz	RECRUITING
Spain	Pamplona Clinica Univ. de Navarra	RECRUITING
Spain	Salamanca Hosp Clinico Univ de Salamanca	RECRUITING

Geo Locations

-37.814, 144.96332

-31.98184, 115.8073

-33.91439, 151.24895

55.67594, 12.56553

55.39594, 10.38831

31.76904, 35.21633

32.08088, 34.78057

41.38879, 2.15899

40.4165, -3.70256

42.81687, -1.64323

40.96882, -5.66388

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