Clinical trial · Interventional
Phase 1/2 Dose Escalation Study in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia
Phase 1/2 Open-Label, Multiple-dose, Dose-escalation Study to Evaluate the Safety and Tolerability of IMO-8400 in Patients With Relapsed or Refractory Waldenstrom's Macroglobulinemia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of efficacy
Summary
Brief summary (as posted)
Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 90% of the patients with Waldenström's macroglobulinemia. MYD88 is a key linker protein in the signaling pathway of Toll Like Receptors (TLRs) 7, 8, and 9, and IMO-8400 is an oligonucleotide specifically designed to inhibit TLRs 7,8, and 9. The scientific hypothesis for use of IMO-8400 to treat patients with Waldenström's macroglobulinemia depends on the inhibition of mutant MYD88 signaling in the TLR pathway, thereby interrupting the proliferation of cell populations responsible for the propagation of the disease.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Waldenstrom's Macroglobulinemia | Waldenstrom Macroglobulinemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMO-8400 | Drug | Immunomodulatory Oligonucleotide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IMO-8400 at escalating dose levels
- description
- IMO-8400 at escalating dose levels by subcutaneous injection
- interventionNames
- Drug: IMO-8400
Primary outcomes (1)
- measure
- Safety and Tolerability of IMO-8400 in Patients With Waldenstrom's Macroglobulinemia
- timeFrame
- Up to 24 weeks
- description
- Safety and tolerability of IMO-8400 in patients with Waldenstrom's Macroglobulinemia: Assessment of adverse events
Secondary outcomes (4)
- measure
- Best Overall Response
- timeFrame
- Up to 24 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Patients must have a diagnosis of relapsed Waldenstrom's Macroglobulinemia. In addition to the above, key inclusion and exclusion criteria are listed below. Inclusion Criteria: 1. At least 18 years of age. 2. Agree to use contraception 3. Hemoglobin ≥ 7.5 g/dL, - Absolute neutrophil count ≥ 1.0 x 109/L (1000/mm3), - Platelets ≥ 50,000/μL Exclusion Criteria: 1. Is nursing or pregnant 2. Has BMI \> 34.9 kg/m2. 3. Has a positive test for human immunodeficiency virus (HIV-1 or -2) hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg). 4. Receiving chronic systemic corticosteroid therapy \> 20 mg of prednisone daily. 5. Being treated with other anti-cancer therapies (approved or investigational). 6. Has, at the initiation of study drug, received cytotoxic chemotherapy or a Bruton's tyrosine kinase (BTK)-inhibitor (e.g. ibrutinib) within the past 3 weeks or rituximab within the past 2 months 7. Has an active infection requiring systemic antibiotics. 8. Has had surgery requiring general anesthesia within 4 weeks of starting the study. 9. Has autoimmune cytopenia (anemia, thrombocytopenia, leukopenia). 10. Has heart failure of Class III or IV. 11. Has sensory or motor neuropathy limiting daily activities.
References
Publications (0)
Data not yet available