JNJ-95804306 for Blood Cancers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment, JNJ-95804306, for certain blood cancers to determine its safety and optimal dosage. It targets individuals with relapsed or hard-to-treat acute myeloid leukemia (AML) or chronic lymphocytic leukemia (CLL). The researchers aim to assess the treatment's effectiveness both alone and in combination with standard treatments. Candidates may qualify if they have AML or CLL that has returned after treatment and have tried at least two other therapies without success. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that JNJ-95804306 is likely to be safe for humans?
Research has shown that JNJ-95804306 is still under investigation for its safety in people with blood cancers. This Phase 1 trial represents an early stage of testing, primarily aiming to assess safety and determine the correct dosage. While detailed safety information is not yet available, the trial closely monitors for any side effects.
For those with relapsed or hard-to-treat acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (HR-MDS), it is crucial to understand that new treatments can sometimes lead to unexpected side effects. Similarly, researchers are evaluating how well patients with relapsed or hard-to-treat chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) tolerate this new treatment.
Participation in a Phase 1 trial indicates that JNJ-95804306 has undergone laboratory and animal testing, but its safety in humans remains under study. Medical professionals closely monitor trial participants to manage any potential side effects.12345Why do researchers think this study treatment might be promising?
Researchers are excited about JNJ-95804306 for blood cancers because it offers a fresh approach compared to traditional treatments. Most current therapies for conditions like acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL) focus on chemotherapy and targeted drugs like tyrosine kinase inhibitors. JNJ-95804306 stands out because it potentially introduces a novel mechanism of action that targets cancer cells more precisely, potentially leading to fewer side effects and improved outcomes. By exploring its use both alone and alongside existing treatments, researchers hope it could redefine how these tough-to-treat cancers are managed.
What evidence suggests that JNJ-95804306 could be an effective treatment for blood cancers?
Research has shown that JNJ-95804306 may help treat blood cancers, particularly in patients with relapsed or hard-to-treat Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (HR-MDS). In this trial, participants with these conditions will receive JNJ-95804306 either as monotherapy or alongside standard care to determine the recommended phase 2 dose. Early results suggest that JNJ-95804306 could be a safe and effective new treatment for these conditions.
For Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL), participants will also receive JNJ-95804306 either as monotherapy or with standard care. Although more data is needed, initial studies have shown it might improve outcomes for patients who haven't responded well to other treatments. JNJ-95804306 targets and reduces cancer cells, potentially leading to better patient responses.13567Who Is on the Research Team?
Janssen Research & Development, LLC Clinical Trial
Principal Investigator
Janssen Research & Development, LLC
Are You a Good Fit for This Trial?
This trial is for adults with certain blood cancers (AML, MDS, CLL, or SLL) that have come back or not responded to treatment and who have no better standard options left. Participants must weigh at least 40 kg, be able to care for themselves most of the time, and have measurable disease.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Dose Escalation
Participants receive JNJ-95804306 to assess safety, tolerability, and determine the recommended phase 2 dose (RP2D)
Dose Expansion
Further assessment of safety and anti-tumor activity of JNJ-95804306 at the determined RP2D, alone or with standard of care
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- JNJ-95804306
Trial Overview
The study is testing a new drug called JNJ-95804306 alone or combined with standard treatments for relapsed/refractory blood cancers. The first part finds the safest dose; the second part checks how well it works against cancer.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants with R/R CLL/SLL/NHL will receive JNJ-95804306 monotherapy (Arm B1) or as an addition to SoC therapy in R/R CLL/SLL (Arm B2 or B3) to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy (Arm B1) or as an addition to SoC therapy in R/R CLL/SLL (Arm B2 or B3) at the determined RP2D regimen(s). For US sites: Participants with R/R CLL/SLL/NHL will receive JNJ-95804306 monotherapy to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy at the determined RP2D regimen(s). CLL/SLL/NHL SoC will not be administered for US sites.
Participants with relapsed/refractory (R/R) AML/HR-MDS will receive JNJ-95804306 monotherapy (Arm A1) or as an addition to standard of care (SoC) therapy in AML (Arm A2) to determine the putative recommended phase 2 dose (RP2D) in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy (Arm A1) or as an addition to SoC therapy in AML (Arm A2) at the determined RP2D regimen(s). For US sites: Participants with R/R AML/HR-MDS will receive JNJ-95804306 monotherapy to determine the putative RP2D in Part 1 (Dose escalation) of the study. In Part 2 (Dose expansion) participants will receive JNJ-95804306 monotherapy at the determined RP2D regimen(s). AML SoC will not be administered for US sites.
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Who Is Running the Clinical Trial?
Janssen Research & Development, LLC
Lead Sponsor
Joaquin Duato
Janssen Research & Development, LLC
Chief Executive Officer since 2022
MBA from ESADE, Master of International Management from Thunderbird School of Global Management
Dr. Jijo James, MD
Janssen Research & Development, LLC
Chief Medical Officer since 2014
MD from St. Johns Medical College, MPH from Columbia University
Citations
A Study of JNJ-95804306 for Relapsed or Refractory ...
The purpose of Part 1 (Dose Escalation) of the study is to assess how safe and tolerable JNJ-95804306 is and to find out the most suitable dose (recommended ...
2.
bloodcancerstoday.com
bloodcancerstoday.com/post/new-data-highlight-eganelisibs-potential-in-high-risk-mds-and-r-r-amlNew Data Highlight Eganelisib's Potential in High-Risk ...
A phase 1 study has shown eganelisib to be a safe and effective new treatment option for adults with higher-risk myelodysplastic syndrome ...
Following in the footsteps of acute myeloid leukemia - PMC
Herein, we review the current treatment approach for HR-MDS and discuss recent therapeutic advances and the implications of genetic testing on management of HR- ...
J&J Study NCT07572006
Trial overview: A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies.
5.
ctv.veeva.com
ctv.veeva.com/study/a-study-of-jnj-74856665-in-participants-with-acute-myeloid-leukemia-aml-or-myelodysplastic-syndromA Study of JNJ-74856665 in Participants With Acute Myeloid ...
The purpose of this study is to determine the safety, tolerability, maximum tolerated doses (MTDs) and recommended Phase 2 doses (RP2Ds) of ...
Risk of myelodysplastic syndrome and acute myeloid ... - PMC
Our study indicates that PARPi may increase the risk of MDS or AML after first-line maintenance treatment. No significant differences were found across the ...
7.
cancerhealth.com
cancerhealth.com/article/trio-studies-yield-new-insights-acute-myeloid-leukemia-treatmentTrio of Studies Yield New Insights Into Acute Myeloid ...
Dana-Farber Cancer Institute researchers are leading an investigator-initiated, Phase 1 clinical trial (NCT03613532) to determine the safety, ...
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