JNJ-80948543
DrugJNJ-80948543 will be administered as subcutaneous (SC) or intravenous (IV) injection.
NCT Number: NCT06660563
The purpose of this study is to determine the recommended phase 2 regimen (RP2R) for JNJ-80948543 in combination with JNJ-75348780 (Part 1: Dose Escalation) and to further assess the safety of JNJ-80948543 at the RP2R in combination with JNJ-75348780 (Part 2: Dose Expansion).
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Phase 1
Concord Hospital, Concord, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-80948543 will be administered as subcutaneous (SC) or intravenous (IV) injection.
JNJ-75348780 will be administered as SC injection.
Time frame: Up to 1 year and 10 months
Number of participants with DLT will be reported. DLTs are defined as any of the treatment-related toxicities: any toxicity that would require discontinuation of treatment; Fatal toxicity; Non-hematologic toxicity (Grade 3 toxicity or higher with exceptions); and Hematologic Toxicity (Grade 4 neutrophil count decrease; Grade 4 febrile neutropenia; Grade 3 febrile neutropenia that does not recover with best supportive care within 7 days; Grade 4 platelet count decrease for >=7 days or Grade >3 with Grade >=2 bleeding; Grade 4 anemia).
Time frame: Up to 1 year and 10 months
An AE is any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non-investigational) product. An AE does not necessarily have a causal relationship with the intervention.
Time frame: Up to 1 year and 10 months
Serum Concentration for JNJ-80948543 and JNJ-75348780 will be reported.
Time frame: Up to 1 year and 10 months
AUC tau is defined as area under the serum concentration-time curve during a dosing interval for JNJ-80948543 and JNJ-75348780.
Time frame: Up to 1 year and 10 months
Cmax for JNJ-80948543 and JNJ-75348780 will be reported.
Time frame: Up to 1 year and 10 months
Tmax is the time to reach maximum observed serum concentration for JNJ-80948543 and JNJ-75348780.
Time frame: Up to 1 year and 10 months
Number of participants with presence of anti-drug antibodies of JNJ-80948543 and JNJ-75348780 will be assessed.
Time frame: Up to 1 year and 10 months
ORR is defined as the percentage of participants who have a best response of partial response (PR) or better as assessed by the investigator based on standard response criteria.
Time frame: Up to 1 year and 10 months
CR is defined as the percentage of participants who achieve a best response of CR as assessed by the investigator based on standard response criteria.
Time frame: Up to 1 year and 10 months
DOR is defined as the time from the first efficacy evaluation at which the participant meet all criteria for a response of PR or better to the date of first documented evidence of progressive disease or death as assessed by the investigator based on standard response criteria.
Janssen Research & Development, LLC
Industry
A Phase 1b Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers (TCEs) in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoid (R/R B-Cell NHL) Malignancies
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02690545
Hemic and Lymphatic Diseases, Immune System Diseases
Chapel Hill, North Carolina, United States
View Trial DetailsNCT06470438
Hemic and Lymphatic Diseases, Immune System Diseases
Beijing, China
View Trial DetailsNCT06139406
Hemic and Lymphatic Diseases, Immune System Diseases
Heidelberg, Australia
View Trial DetailsNCT05421663
Hemic and Lymphatic Diseases, Immune System Diseases
Duarte, California, United States
View Trial Details