Clinical trial · Interventional
Single Agent JNJ-56022473 in MDS and AML Patients FAILING HYPOMETHYLATING AGENT BASED THERAPY
Single Agent JNJ-56022473 in MDS and AML Patients Failing Hypomethylating Agent Based Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollement was stopped due to a recommendation by the IDMC/FDA for a parallel clinical trial with TALA, where potentielly no efficancy could be determined.
Summary
Brief summary (as posted)
The outcome of HMA-refractory patients with MDS or AML is dismal with a median survival of 5 months after failure, representing a significant unmet medical need due to the very limited treatment options. In this context, a specific targeting of the leukemic stem cell (LSC) seems a promising option to selectively combat the leukemic progenitor cells. In fact, CD123 is overexpressed in AML and MDS progenitors making it an attractive target for immunotherapy-based approaches. JNJ-56022473 is a promising compound that has been engineered with regard to this strategy and the current phase II trial has the aim to evaluate the overall hematological response rate at 3 months in HMA refractory/relapsed AML and MDS patients.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia (AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndrome (MDS) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Automated CBC | Procedure | — | UNRESOLVED |
| Bone marrow analyses and CBC with differential | Procedure | — | UNRESOLVED |
| Central biobanking | Other | — | UNRESOLVED |
| Cytogenetic analysis | Genetic | — | UNRESOLVED |
| Flow cytometry analyses | Other | — | UNRESOLVED |
| Histopathology analysis | Procedure | — | UNRESOLVED |
| JNJ-56022473 | Drug | — | UNRESOLVED |
| Pregnancy Test | Procedure | — | UNRESOLVED |
| Serum chemistry | Procedure |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Arm
- description
- JNJ-56022473 will be given intravenously to all subjects at a dose of 9 mg/kg once every 14 days for an initial treatment period of 3 months (6 infusions). Responders will then receive up to 20 additional infusions whereas for non-responders the initial treatment will be followed by a up to 9 months observation period without further JNJ-56022473 treatment. Thus, the individual study duration for a subject will be approx. 1 year. A follow up visit will be performed after 3 months after last study drug administration for all patients to track pregnancy status according to IB.
- interventionNames
- Drug: JNJ-56022473
- Procedure: Bone marrow analyses and CBC with differential
- Other: Flow cytometry analyses
- Other: Central biobanking
- Procedure: Histopathology analysis
- Genetic: Cytogenetic analysis
- Procedure: Serum chemistry
- Procedure: Automated CBC
- Procedure: Pregnancy Test
Primary outcomes (1)
- measure
- Overall hematological response rate
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥18 years of age * Diagnosis of AML or MDS * At least ≥ 5% BM blasts at the time of screening (done by central morphology) * At least one cytopenia (ANC \< 1800/μL or platelet count \< 100,000/μL or hemoglobin \< 10 g/dL) * Failure to achieve complete or partial response or hematological improvement after at least six (azacitidine) or four (decitabine) 4-week treatment cycles administered during the past two years OR * Relapse after initial complete or partial response or hematological improvement observed after at least six (azacitidine) or four (decitabine) 4-week treatment cycles administered during the past two years OR * Intolerance to treatment with HMA (hypomethylating agents) defined by drug-related ≥ Grade 3 liver or renal toxicity leading to treatment discontinuation during the past two years * Failed to respond to, relapsed following, not eligible, or opted not to participate in bone marrow transplantation * Off all other treatments for AML/MDS for at least four weeks; Filgrastim (G-CSF) and erythropoietin are allowed before and during the study as clinically indicated * No medical need for or patient opted not to receive induction chemotherapy * ECOG performance status of 0-2 * Willing to adhere to the prohibitions and restrictions specified in the protocol * Signed informed consent Exclusion Criteria: * Previous treatment with a CD123 agent or T- or NK cell redirecting therapy * Patients having received intensive chemotherapy to treat HMA failure * Diagnosis of acute promyelocytic leukemia (APL) * WBC \> 15 GPT/L * Any active malignancy within the past year, except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix or breast * Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia * Active infection not adequately responding to appropriate therapy * Total bilirubin \> 1.5 mg/dL not related to hemolysis or Gilbert's disease * ALT/AST \> 2.5 x upper limit of normal * Serum creatinine \> 2.0 mg/dL * Patients who are unwilling to follow highly effective contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives, contraceptive injections, intrauterine device, , contraceptive patch, surgical sterilization or true sexual abstinence) before entry, at least at screening, throughout the study and within 3 months after last study drug administration * Female patients with reproductive potential who do not have a negative urine β-HCG pregnancy test at screening and prior to the first study drug administration at visit 1 (day 0) of JNJ-56022473 treatment period. * Female patients who are lactating
References
Publications (0)
Data not yet available