NCT07572006 A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies
| NCT ID | NCT07572006 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Janssen Research & Development, LLC |
| Condition | Hematologic Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 280 participants |
| Start Date | 2026-05-13 |
| Primary Completion | 2029-05-18 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 280 participants in total. It began in 2026-05-13 with a primary completion date of 2029-05-18.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 phase 2 dose \[RP2D\]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone and/or when administered in addition to standard of care (SoC) therapy at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system). For US sites: 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 phase 2 dose \[RP2D\]) of JNJ-95804306. The purpose of Part 2 (Dose Expansion) is to further assess the safety of JNJ-95804306 and determine the anti-tumor activity alone at the putative RP2D(s) regimens in participants with hematological malignancies (cancer that begins in blood-forming tissue, such as the bone marrow, or in the cells of the immune system).
Eligibility Criteria
Inclusion criteria: For Arm A: * Have a diagnosis of: Acute myeloid leukemia (AML) per International Consensus Classification (ICC) 2022 or myelodysplastic syndromes (MDS) per world health organization (WHO) 2022 classified as moderate high, high, or very high-risk per the molecular international prognostic scoring system (IPSSM). All participants must have relapsed or refractory disease and have exhausted or are ineligible for standard therapeutic options * Body weight greater than or equal to (\>=) 40 kilograms (kg) * Eastern cooperative oncology group (ECOG) performance status of 0 to 2 For Arm B: * Have a diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL/SLL) that meets International workshop on chronic lymphocytic leukemia (iwCLL), National cancer institute (NCI) Working Group Guidelines which is relapsed or refractory and requires treatment with no other approved therapies available that would be more appropriate in the investigator's judgment. a. Participants must have received at least 2 prior lines of therapy; b. Participants who have received at least one prior line of therapy but are not eligible or do not have access to standard second line therapies, will be allowed to enroll * Body weight \>= 40 kg * ECOG performance status of 0 to 2 * Have clinically measurable disease * For US sites: Have a diagnosis of CLL/SLL that meets iwCLL, NCI Working Group Guidelines which is relapsed or refractory and requires treatment with no other approved therapies available that would be more appropriate in the investigator's judgment. a. Participants must have received at least 2 prior lines of therapy Exclusion criteria: For Arm A: * Has acute promyelocytic leukemia according to world health organization (WHO) 2016 criteria or known active central nervous system (CNS) involvement of AML/MDS, unless in specific cohort (s) per study evaluation team (SET) decision * Need for supplemental oxygen use to maintain adequate oxygenation * Have evidence of uncontrolled systemic viral, bacterial, or fungal infection. Antimicrobial prophylaxis is permitted * For US sites: Has acute promyelocytic leukemia according to WHO 2016 criteria or known active CNS involvement of AML/MDS For Arm B: * Need for supplemental oxygen use to maintain adequate oxygenation * Have evidence of uncontrolled systemic viral, bacterial, or fungal infection requiring initiation of parenteral treatment as medical intervention * Developed Richter's transformation or prolymphocytic leukemia * Known active CNS or leptomeningeal involvement of CLL/SLL
Contact & Investigator
Janssen Research & Development, LLC Clinical Trial
STUDY DIRECTOR
Janssen Research & Development, LLC
Frequently Asked Questions
Who can join the NCT07572006 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematologic Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07572006 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07572006 currently recruiting?
Yes, NCT07572006 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07572006 trial being conducted?
This trial is being conducted at Indianapolis, United States, Grand Rapids, United States, Piscataway, United States.
Who is sponsoring the NCT07572006 clinical trial?
NCT07572006 is sponsored by Janssen Research & Development, LLC. The principal investigator is Janssen Research & Development, LLC Clinical Trial at Janssen Research & Development, LLC. The trial plans to enroll 280 participants.