Experimental drug duo takes on tough lymphoma
NCT ID NCT06660563
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times
Summary
This early-phase trial tests two experimental drugs, JNJ-80948543 and JNJ-75348780, given together to people with relapsed or refractory B-cell non-Hodgkin lymphoma. The study involves 19 participants and aims to find the safest dose and check for side effects. It is not yet known if the combination will shrink tumors or improve outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JNJ-80948543 and JNJ-75348780 (two experimental drugs that help the immune system attack cancer cells)
- What this could lead to
- If successful, this could point toward a new combination treatment option for people with hard-to-treat B-cell non-Hodgkin lymphoma.
- What could go wrong
- This is a very early Phase 1 trial with only 19 participants, so it is primarily testing safety and dosing. The drugs may cause serious side effects or not work well enough to move forward.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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19 people
The number who actually took part.
- Started
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Oct 2024
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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China Medical University Hospital
Taichung, 40447, Taiwan
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Concord Hospital
Concord, 2139, Australia
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Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
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Hosp. Clinic de Barcelona
Barcelona, 08036, Spain
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Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007, Spain
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Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
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Inst. Cat. Doncologia-H Duran I Reynals
L'Hospitalet de Llobregat, 08908, Spain
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Macquarie University Hospital
North Ryde, 2109, Australia
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National Taiwan University Hospital
Taipei, 100, Taiwan
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St Vincents Hospital Melbourne
Fitzroy, 3065, Australia
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University Hospitals Of Leicester Nhs Trust
Leicester, Le1 5ww, United Kingdom
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Other studies related to the condition(s) this trial covers.
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