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Trial Title:
A Study of JNJ-87801493 in Combination With T-Cell Engagers in Participants With B-cell Non-Hodgkin Lymphoid (NHLs) Cancer
NCT ID:
NCT06139406
Condition:
Lymphoma, Non-Hodgkin
Conditions: Official terms:
Lymphoma, Non-Hodgkin
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
JNJ-87801493
Description:
JNJ-87801493 will be administered subcutaneously.
Arm group label:
Part 1: Dose escalation
Arm group label:
Part 2:Dose expansion
Intervention type:
Drug
Intervention name:
JNJ-80948543
Description:
JNJ-80948543 will be administered subcutaneously.
Arm group label:
Part 1: Dose escalation
Arm group label:
Part 2:Dose expansion
Intervention type:
Drug
Intervention name:
JNJ-75348780
Description:
JNJ-75348780 will be administered subcutaneously.
Arm group label:
Part 1: Dose escalation
Arm group label:
Part 2:Dose expansion
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].
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Austin Hospital
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Alfred Hospital
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Facility:
Name:
Linear Clinical Research Ltd
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
Scientia Clinical Research
Address:
City:
Randwick
Zip:
2031
Country:
Australia
Status:
Recruiting
Facility:
Name:
Rigshospitalet
Address:
City:
Copenhagen
Zip:
DK-2100
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Odense University Hospital
Address:
City:
Odense
Zip:
5000
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Hadassah Medical Center
Address:
City:
Jerusalem
Zip:
9112001
Country:
Israel
Status:
Recruiting
Facility:
Name:
Sourasky (Ichilov) Medical Center
Address:
City:
Tel Aviv
Zip:
6423906
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hosp Univ Vall D Hebron
Address:
City:
Barcelona
Zip:
08035
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp Univ Fund Jimenez Diaz
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Clinica Univ. de Navarra
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hosp Clinico Univ de Salamanca
Address:
City:
Salamanca
Zip:
37007
Country:
Spain
Status:
Recruiting
Start date:
December 6, 2023
Completion date:
July 8, 2026
Lead sponsor:
Agency:
Janssen Research & Development, LLC
Agency class:
Industry
Source:
Janssen Research & Development, LLC
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06139406
