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New cancer drug shows promise in early human trial

NCT ID NCT03573310

Disease control Sponsor: Janssen Research & Development, LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-stage trial tested a new oral drug, JNJ-64619178, in 114 people with advanced cancers (including solid tumors, lymphoma, and myelodysplastic syndromes) that had stopped responding to standard treatments. The main goals were to find a safe dose and check for side effects. Researchers also looked for signs that the drug might control tumor growth.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
JNJ-64619178 (a drug that blocks a protein called PRMT5, which may slow cancer growth)
What this could lead to
If it works, this could point toward a new treatment option for people with advanced cancers that have not responded to other therapies.
What could go wrong
This is a very early Phase 1 trial with only 114 participants, so the drug may not prove effective or safe enough for further testing. Side effects, including serious toxicities, are possible.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

114 people

The number who actually took part.

Started

Jul 2018

Finished

Sep 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * B cell non-Hodgkin lymphoma (NHL) or solid tumors, or lower risk MDS * At least 1 measurable site of disease for B cell-NHL and solid tumors * Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1 * Adequate organ function * Women of childbearing potential must have a negative highly sensitive serum (beta-human chorionic gonadotropin \[beta-hCG\]) at screening and prior to the first dose of study drug. Women must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for a period of 90 days after receiving the last dose of study drug Exclusion Criteria: * History of, or known, central nervous system (CNS) involvement * Prior solid organ transplantation * Either of the following: a) Received an autologous stem cell transplant less than or equal (\<=) 9 months before the first dose of study drug B) Prior treatment with allogenic stem cell transplant * History of malignancy (other than the disease under study) within 3 years before the first administration of study drug. Exceptions include squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years * Known allergies, hypersensitivity, or intolerance to JNJ-64619178 or its excipient

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Conditions

The condition(s) this trial relates to.

B-cell non-Hodgkin lymphoma myelodysplastic syndrome Myelodysplastic Syndromes neoplasm non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Myelodysplastic syndromes Neoplasms Non-Hodgkin lymphoma Solid tumor, adult

Contacts and locations

Locations

  • Carmel Medical Center

    Haifa, 34362, Israel

  • Clinica Univ. de Navarra

    Pamplona, 31008, Spain

  • Florida Specialist and Cancer Institute

    Sarasota, Florida, 34232, United States

  • Goethe Universität Frankfurt

    Frankfurt am Main, 60590, Germany

  • Hadassah Medical Center

    Jerusalem, 9112001, Israel

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007, Spain

  • Hosp Univ Fund Jimenez Diaz

    Madrid, 28040, Spain

  • Hosp Univ Vall D Hebron

    Barcelona, 08035, Spain

  • Hosp. Univ. Germans Trias I Pujol

    Badalona, 08916, Spain

  • Hosp. Virgen Del Rocio

    Seville, 41013, Spain

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Ohio State University

    Columbus, Ohio, 43210, United States

  • Princess Margaret Cancer Centre University Health Network

    Toronto, Ontario, M5G1Z5, Canada

  • St. Paul's Hospital

    Vancouver, British Columbia, V6E 1M7, Canada

  • Tel Aviv Sourasky MC

    Tel Aviv, 6423906, Israel

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, 40225, Germany

  • Universitaetsklinikum Leipzig

    Leipzig, 04103, Germany

  • University of Texas, MD Anderson Cancer Center

    Houston, Texas, 77030, United States

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