Sign in

NCT04540796CompletedPhase 1

A Study of JNJ-75348780 in Participants With Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL)

A Phase 1, First-in-Human, Dose Escalation Study of the JNJ-75348780 Bispecific Antibody Targeting CD3 and CD22 in Participants With NHL and CLL

Source: ClinicalTrials.gov · Last updated 10 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The purpose of this study is to characterize safety and to determine the putative recommended Phase 2 dose(s) (RP2D\[s\]) and optimal dosing schedule(s) of JNJ-75348780 in participants with relapsed/ refractory B-cell Non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia (CLL) in Part A and to further characterize the safety at the RP2D(s) in Part B.

Status (registry)
Completed
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
147 (actual)
First submitted
2 Sept 2020
Start date
20 Nov 2020
Primary completion date
9 Sept 2025
Lead sponsor
Janssen Research & Development, LLC
NCT number
NCT04540796
EU CT number
2023-504403-92-00
EudraCT number
2020-001183-29

What you commit to

  • Study type: Interventional · Phase 1
  • Participants enrolled: 147
  • From 20 Nov 2020 to the primary completion date, 9 Sept 2025
  • 32 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior solid-organ transplantation
  • Either of the following: a) received an autologous stem cell transplant \<=3 months before the first dose of JNJ 75348780, b) prior treatment with allogenic stem cell transplant \<= 6 months before the first dose of JNJ-75348780, or has evidence of graft versus host disease that requires immunosuppressant therapy
  • Prior chemotherapy, targeted therapy, immunotherapy or radiotherapy (with the exclusion of palliative radiation to limited sites that do not interfere with response assessment based on a sufficient number of other sites), within 2 weeks before the first administration of study drug. 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, whichever is longer. For investigational agents with long half-lives a wash-out of 4 weeks is acceptable. Participants who received prior treatment with anti-CD20 \* anti-CD3 bispecific therapy will be excluded until a dedicated cohort(s) is opened as determined by the SET

Other illness

  • Active autoimmune disease that requires systemic immunosuppressive medications (example, chronic corticosteroid, methotrexate, or tacrolimus)
  • History of malignancy (other than the disease under study in the cohort to which the participant is assigned) within 1 year prior to the first administration of study drug. Exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy which in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 1 year before the first dose of study drug. Concomitant malignancies that are unlikely to progress and/or preclude evaluation of study endpoints may be allowed after discussion with the Study Responsible Physician

Other

  • Known central nervous system (CNS) involvement with lymphoma

Who the study is looking for

  • Histologic documentation of disease: B-cell NHL or 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 a) If diffuse large B-cell lymphoma (DLBCL): received, or not eligible for high-dose chemotherapy and autologous stem cell transplantation with curative intent, b) If follicular lymphoma (FL)/ marginal zone lymphoma (MZL) (except mucosa-associated lymphoid tissue \[MALT\]), or Waldenstrom macroglobulinemia (WM): previously treated with a minimum of 2 prior lines of systemic therapy, with at least 1 prior line containing an anti-CD20 antibody, c) If mantle cell lymphoma (MCL): previously treated with at least 1 prior line of systemic therapy containing an anti-CD20 antibody. CLL or small lymphocytic lymphoma (SLL): relapsed or refractory with at least 2 prior lines of therapy to include a bruton tyrosine kinase inhibitor (BTKi) and/or a B-cell lymphoma (BCL)2 inhibitor, if eligible. 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 (ms) based on the average of triplicate assessments performed no more than 5 (plus minus \[+ -\] 3) minutes apart
  • Women of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta human chorionic gonadotropin) at screening and prior to the first dose of study drug
  • Women must be: a) not of childbearing potential, b) of childbearing potential and practicing a highly effective, preferably user independent method of contraception (failure rate of less than (\<) 1 percent (%) per year when used consistently and correctly) and agrees to remain on a highly effective method while receiving study drug and until 90 days after last dose

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (32)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Austin Hospital
Coordinator of this site? Confirm its status
HeidelbergAustraliaUnknown status
Linear Clinical Research Ltd
Coordinator of this site? Confirm its status
NedlandsAustraliaUnknown status
Institut Catala d'Oncologia
Coordinator of this site? Confirm its status
BadalonaSpainCompleted
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainCompleted
Hospital Universitario Fundación Jiménez Díaz
Coordinator of this site? Confirm its status
MadridSpainCompleted
Clínica Universidad de navarra
Coordinator of this site? Confirm its status
PamplonaSpainCompleted
Hospital Universitario De Salamanca
Coordinator of this site? Confirm its status
SalamancaSpainCompleted
Centre Hospitalier Universitaire de Lille
Coordinator of this site? Confirm its status
LilleFranceCompleted
Centre Hospitalier Universitaire de Nantes
Coordinator of this site? Confirm its status
NantesFranceCompleted
Hospices Civils de Lyon
Coordinator of this site? Confirm its status
Pierre-BéniteFranceCompleted
Leicester Royal Infirmary
Coordinator of this site? Confirm its status
LeicesterUnited KingdomUnknown status
Kings College Hospital
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
The Christie NHS Foundation Trust
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
Plymouth Hospital NHS Trust
Coordinator of this site? Confirm its status
PlymouthUnited KingdomUnknown status
Rambam Medical Center
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Carmel Medical Center
Coordinator of this site? Confirm its status
HaifaIsraelUnknown status
Hadassah medical Center
Coordinator of this site? Confirm its status
JerusalemIsraelUnknown status
Sheba medical center
Coordinator of this site? Confirm its status
Ramat GanIsraelUnknown status
Tel-Aviv Sourasky MC
Coordinator of this site? Confirm its status
Tel AvivIsraelUnknown status
Seoul National University Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
The Catholic University of Korea Seoul St Marys Hospital
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Asan Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Samsung Medical Center
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
Coordinator of this site? Confirm its status
SeoulSouth KoreaUnknown status
Chang Gung Memorial Hospital, Kaohsiung
Coordinator of this site? Confirm its status
Kaohsiung CityTaiwanUnknown status
China Medical University Hospital
Coordinator of this site? Confirm its status
TaichungTaiwanUnknown status
Taichung Veterans General Hospital
Coordinator of this site? Confirm its status
TaichungTaiwanUnknown status
National Cheng Kung University Hospital
Coordinator of this site? Confirm its status
TainanTaiwanUnknown status
National Taiwan University Hospital
Coordinator of this site? Confirm its status
TaipeiTaiwanUnknown status
University of Alabama at Birmingham
Coordinator of this site? Confirm its status
BirminghamUnited StatesUnknown status
The University of Texas MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Icahn School of Medicine at Mount Sinai
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.