Study of 3D189 in Patients With Hematologic Malignancies
NCT05320809 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2025-05-29
Summary
To assess the safety, immunogenicity and preliminary efficacy of 3D189 in patients with hematological malignancies.
Conditions
- Acute Leukemia
- Multiple Myeloma
- Non-Hodgkin Lymphoma
- Higher-risk Myelodysplastic Syndrome
Interventions
- 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).
Sponsors & Collaborators
-
3D Medicines
lead INDUSTRY
Principal Investigators
-
jianxiang wang, Ph.D · Institute of Hematology & Blood Diseases Hospital,Chinese Academy of Medical Science & Peking Union Medical College
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-01
- Primary Completion
- 2026-06-30
- Completion
- 2026-12-31
- FDA Drug
- Yes
Countries
- China
Study Locations
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