Clinical trial · Interventional
Dose Escalation Study in Patients With Relapsed or Refractory DLBCL and MyD88 L265P Mutation
Phase I/II Open-label, Multiple-dose, Dose-escalation Study to Evaluate the Safety and Tolerability of IMO-8400 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma and Presence of the MyD88 L265P Mutation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Recent reports have identified a specific oncogenic mutation L265P of the MYD88 gene in approximately 30% of the patients with the activated B-cell (ABC) type of Diffuse Large B Cell Lymphoma (DLBCL). MYD88 is an initial adapter linker protein in the signaling pathway of the Toll Like Receptors (TLRs), including the endosomal TLRs 7, 8, and 9, for which the ligands are nucleic acids. IMO-8400 is an oligonucleotide specifically designed to inhibit ligand activation of TLRs 7,8, and 9. Recent studies indicate that in the presence of L265P mutation ligand activation of those TLRs results in markedly increased signaling with subsequent increased cell activation, cell survival, and cell proliferation. The scientific rationale for assessing the use of IMO-8400 to treat patients with DLBCL and the L265P mutation is based on laboratory observations that IMO-8400 inhibits ligand-based activation of cells with the mutation and decreases the survival and proliferation of the 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 |
|---|---|---|---|
| Diffuse Large B Cell Lymphoma | Diffuse Large B-Cell Lymphoma | CURATED_BROADER | 0.80 |
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
- description
- IMO-8400 0.3 mg/kg twice weekly, 0.6 mg/kg twice weekly, or 1.2 mg/kg twice weekly
- interventionNames
- Drug: IMO-8400
Primary outcomes (1)
- measure
- Number of Participants With Adverse Events, Injection Site Reactions, and Concomitant Medications
- timeFrame
- Up to 2 years from first patient visit
- description
- Frequency of adverse events, injection site reactions, and concomitant medications observed
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have a diagnosis of Diffuse Large B Cell Lymphoma (DLBCL) of non-GCB subtype, established according to the World Health Organization (WHO) criteria that has been tested for the MyD88 L265P mutation. * In addition to the above, key inclusion and exclusion criteria are listed below. 1. Be at least 18 years of age 2. Agree to use contraception Exclusion Criteria: 1. Is nursing or pregnant 2. DLBCL of GCB subtype 3. Has BMI \> 34.9 kg/m2 4. Has a positive test for human immunodeficiency virus (HIV-1 or -2) hepatitis C virus (HCV) or hepatitis B surface antigen (HBsAg) 5. Receiving chronic systemic corticosteroid therapy \> 20 mg of prednisone daily 6. Being treated with other anti-cancer therapies (approved or investigational) 7. Has an active infection requiring systemic antibiotics 8. Has had surgery requiring general anesthesia within 4 weeks of starting the study 9. Has heart failure of Class III or IV
References
Publications (0)
Data not yet available