NCT05320809

Study of 3D189 in Patients With Hematologic Malignancies

A Phase I Study to Evaluate the Safety and Immunogenicity of 3D189 in Patients With Hematologic Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: 3D Medicines · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the safety, immunogenicity and preliminary efficacy of 3D189 in patients with hematological malignancies.

Detailed description

This is a phase 1, open-label, non-comparative, multicenter study of 3D189 (also known as galinpepimut-S), a multivalent peptide vaccine targeting Wilms Tumor-1 (WT1), for maintenance immunotherapy in patients with WT1-positive hematological malignancies, including patients with acute leukemia (AL) patients in complete remission (CR), or multiple myeloma (MM), non-Hodgkin lymphoma (NHL) or higher-risk myelodysplastic syndrome (MDS) patients who have received at least first-line standard therapy and recently achieved CR or partial remission (PR), if the latter is the best achievable response for the patient.

Conditions

• Acute Leukemia
• Multiple Myeloma
• Non-Hodgkin Lymphoma
• Higher-risk Myelodysplastic Syndrome

Interventions

Type	Name	Description
BIOLOGICAL	3D189	3D189 (200 mcg per peptide x 4 WT1 peptides within the drug product; total weight: 800 mcg) is mixed (1:1 v/v) and emulsified with the adjuvant Montanide, which is then injected subcutaneously to the patient. A maximum of 15 total injections of 3D189 will be administered as follows: 1. Initial immunization induction phase（the first series of 6 injections of 3D189): every 2 weeks (Weeks 0 - 10) followed by a 4-week period of no treatment. 2. Early immune booster phase（the second series of 6 injections of 3D189): every 4 weeks (between Weeks 14 and 34) followed by a 6-week period of no treatment. 3. Late immune booster phase（the third series of 3 injections of 3D189): every 6 weeks (between Weeks 40 and 52).

Timeline

• Start date: 2022-08-01
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2022-04-11
• Last updated: 2025-05-29

Locations

4 sites across 1 country: China

Regulatory

• FDA-regulated drug study