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No longer recruiting (closed or complete)Last updated: 22 June 2026

Co-stim: This study is evaluating the safety, and determining the recommended dose regimen, of a drug called JNJ-87801493 when given in combination with immunotherapy (CD3 T-cell engagers) in people with relapsed or refractory B-cell non-Hodgkin lymphoid cancersA Phase 1, First-in-human Study of JNJ-87801493 in Combination With CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies (NHLs)

Trial purpose

Medical clipboardCancer treatment

Tumor type

Blood Cancers Haematological

Age

People18+

Trial acronym

Co-stim

Clinical summary

Summary

This study has two parts: Part A (Dose Escalation) and Part B (Dose Expansion).

In Part A, participants will receive one cycle of T-cell engager (TCE) monotherapy (step up to target dose) with either JNJ-80948543 or JNJ-75348780 followed by initiation of combination therapy with JNJ-87801493 one week later.

In Part B, participants with specific B-cell non-Hodgkin lymphoid histologies will receive recommended phase 2 regimen (RP2R) of JNJ-87801493 with TCE as determined in Part 1.

All treatments will be administered subcutaenously, which is an injection under the skin.

Conditions

This trial is treating people with B-cell non-Hodgkin lymphomas

Eligibility

Inclusion

  • Histologic documentation of B-cell NHL. All participants must have relapsed or refractory disease with no other approved therapies available that would be more appropriate in the investigator's judgment
  • Part 1 participants must have evaluable or measurable disease and Part 2 participants must have measurable disease;all as defined by the appropriate disease response criteria
  • 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

  • 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 14 days 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

Inclusion

  • You have had treatment, but your cancer has come back (relapsed or recurrent).
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

Participating hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Janssen Research & Development, LLC

Scientific Title

A Phase 1, First-in-human Study of JNJ-87801493 in Combination With CD3 T-Cell Engagers in Participants With Relapsed/Refractory B-cell Non-Hodgkin Lymphoid Malignancies (NHLs)

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