Clinical trial NCT06660563: A Study of JNJ-80948543 in Combination With Other CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-Cell Non-Hodgkin Lymphoma (R/R B-Cell NHL)
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Lymphoma, Non-Hodgkin
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2024-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* Histologic documentation of diffuse large B-cell lymphoma (DLBCL), including high-grade B-cell lymphoma and DLBCL arising from indolent lymphoma. All participants must have received at least 2 prior lines of therapy
* Participants must have measurable disease as defined by the appropriate disease response criteria
* Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
* 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 24 hours before 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
* 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 defined as the need for supplemental oxygen to maintain adequate oxygenation
* Evidence of clinically significant and/or symptomatic infection (viral, bacterial, or fungal) at the time of study drug initiation. Anti-microbial treatment for infection must be discontinued at least 7 days before the first dose of study drug

Primary outcomes:
measure: Number of Participants with Dose-limiting Toxicity (DLT)
timeFrame: Up to 1 year and 10 months
measure: Number of Participants with Adverse Events (AEs)
timeFrame: Up to 1 year and 10 months
Secondary outcomes:
measure: Serum Concentration of JNJ-80948543 and JNJ-75348780
timeFrame: Up to 1 year and 10 months
measure: Area Under the Curve (AUCtau) for JNJ-80948543 and JNJ-75348780
timeFrame: Up to 1 year and 10 months
measure: Maximum Serum Concentration (Cmax) for JNJ-80948543 and JNJ-75348780
timeFrame: Up to 1 year and 10 months
measure: Time to Reach Cmax (Tmax) for JNJ-80948543 and JNJ-75348780
timeFrame: Up to 1 year and 10 months
measure: Number of Participants with Presence of Anti-Drug Antibodies of JNJ-80948543 and JNJ-75348780
timeFrame: Up to 1 year and 10 months
measure: Overall Response Rate (ORR)
timeFrame: Up to 1 year and 10 months
measure: Complete Response Rate (CRR)
timeFrame: Up to 1 year and 10 months
measure: Duration of Response (DoR)
timeFrame: Up to 1 year and 10 months
Other outcomes:
Locations:
city: Concord
country: Australia
facility: Concord Hospital
city: Fitzroy
country: Australia
facility: St Vincents Hospital Melbourne
city: North Ryde
country: Australia
facility: Macquarie University Hospital
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Hosp. Clinic de Barcelona
city: L Hospitalet De Llobregat
country: Spain
facility: Inst. Cat. Doncologia-H Duran I Reynals
city: Madrid
country: Spain
facility: Hosp. Gral. Univ. Gregorio Maranon
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei City
country: Taiwan
facility: National Taiwan University Hospital
city: Leicester
country: United Kingdom
facility: University Hospitals Of Leicester Nhs Trust
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References: