New combo therapy targets tough lymphoma in early trial
NCT ID NCT06139406
First seen Jun 27, 2026 · Last updated Aug 28, 2026 · Updated 4 times
Summary
This early-phase study tests a new drug (JNJ-87801493) combined with immune-activating therapies (T-cell engagers) in about 70 people whose B-cell non-Hodgkin lymphoma has returned or stopped responding to other treatments. The main goals are to check safety and find the best dose. The trial is not yet recruiting and is actively ongoing.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JNJ-87801493 combined with T-cell engagers (JNJ-80948543 or JNJ-75348780)
- What this could lead to
- If successful, this could point toward a new treatment option for people with hard-to-treat B-cell non-Hodgkin lymphoma.
- What could go wrong
- This is a very early (Phase 1) and small (70 participants) trial focused on safety, not yet on effectiveness. The combination may cause serious side effects like cytokine release syndrome, and it may not work for many patients.
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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70 people
The number who actually took part.
- Started
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Dec 2023
- Expected to finish
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Sep 2026
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 B-cell NHL. All participants in part 1 must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment. In Part 2, participants with diffuse large B-cell lymphoma (DLBCL) or other high-grade B cell lymphoma and participants with transformed lymphoma from low-grade B cell malignancies who relapsed or failed to respond to only one prior systemic treatment regimen can be included * Part 1 participants must have evaluable or measurable disease and Part 2 participants must have measurable disease; all as defined by the Lugano criteria for non-Hodgkin lymphoid malignancies (NHL) and the international workshop on Waldenstrom's Macroglobulinemia (IWWM-6) for WM * 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 2 weeks 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
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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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Austin Hospital
Heidelberg, 3084, Australia
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Clinica Univ. de Navarra
Pamplona, 31008, Spain
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Hadassah Medical Center
Jerusalem, 9112001, Israel
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Hosp Clinico Univ de Salamanca
Salamanca, 37007, Spain
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Hosp Univ Fund Jimenez Diaz
Madrid, 28040, Spain
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Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
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Linear Clinical Research Ltd
Nedlands, 6009, Australia
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Odense University Hospital
Odense, 5000, Denmark
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Rigshospitalet
Copenhagen, DK-2100, Denmark
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Scientia Clinical Research
Randwick, 2031, Australia
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Sourasky (Ichilov) Medical Center
Tel Aviv, 6423906, Israel
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The Alfred Hospital
Melbourne, 3004, Australia
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