Back to search
A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies
Hematologic Neoplasms
Clinicaltrials.gov:
EU CTIS:
#2026-525234-39-00
EudraCT:
Other:
#95804306EDI1001
Interested in this trial?
Subscribe or share this trial
Trials at a glance
Status
Enrolling
Condition
Hematologic Neoplasms
Trial type
Interventional
Trial phase
Phase 1
Investigational
product
product
AML SoC
CLL/SLL SoC
JNJ-95804306
Age
18+ years old
Biological sex
All
Placebo?
No
Trial start date
May 13, 2026
Trial end date
September 24, 2032
CT.gov ID
#NCT07572006
Share the trial ID with your doctor to see if trial participation is right for you. Participation depends on an independent medical assessment.
A Study of JNJ-95804306 for Relapsed or Refractory Hematological Malignancies
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).
Primary outcome measures
- Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
- Number of Participants with Adverse Events (AEs) by Severity
Secondary outcome measures
- For US sites: Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
- Serum Concentrations of JNJ-95804306
- Area Under the Curve From Time of Administration until End of Dosing Interval (AUC[t]) of JNJ-95804306
- Maximum Plasma Concentration (Cmax) of JNJ-95804306
- Minimum Plasma Concentration (Cmin) of JNJ-95804306
- Complete Response (CR) in Participants with Acute Myeloid Leukemia (AML)
- Overall Response (OR) in Participants with Myelodysplastic Syndrome (MDS)
- Complete Response (CR) in Participants with MDS
- Overall Response (OR) in Participants with Chronic Lymphocytic Leukemia (CLL)
- Complete Response in Participants with CLL
- Overall Response in Participants with Non-Hodgkin Lymphoma (NHL) Subtypes Including Small Lymphocytic Lymphoma (SLL)
- Complete Response in Participants With NHL Subtypes Including SLL
- Overall Response in WM (Waldenstrom's Macroglobulinemia)
- Complete Response in WM
- Best Overall Response (BOR) Based on Indication-Specific Criteria
- Duration of Response (DoR)
- Time to Response (TTR)
Access detailed information on the trial:
Clinical trials information
© Johnson & Johnson and its affiliates 2026
