Clinical trial · Interventional
PR1 Vaccination in Myelodysplastic Syndrome (MDS)
Phase 2 Study of Proteinase 3 PR1 Peptide Vaccine in Myelodysplastic Syndrome (MDS)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The trial was ended per sponsor due to slow accrual rates.
Summary
Brief summary (as posted)
Primary aim: 1. To determine the immunologic response, using a PR1-HLA-A2 tetramer assay, to 4 subcutaneous (SQ) injections of TVC-PR1 vaccine formulated in Montanide ISA 51 VG followed by granulocyte macrophage colony-stimulating factor (GM-CSF) in low risk and intermediate-1 myelodysplastic syndrome (MDS) patients. Secondary aims: 1. To determine if non-immunologic responders to 4 subcutaneous (SQ) injections of TVCPR1 vaccine formulated in Montanide ISA 51 VG followed by GM-CSF can be converted to immunologic responders by administering 4 additional doses of TVC-PR1 vaccine formulated in Montanide ISA 51 VG followed by GM-CSF. 2. To determine the clinical response to 4 or 8 subcutaneous (SQ) injections of TVC-PR1 vaccine formulated in Montanide ISA 51 VG followed by GM-CSF in patients low risk and intermediate-1 MDS.
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 |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PR-1 vaccine | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PR-1 vaccine
- description
- 4 injections of 0.5 mg PR1 peptide vaccine every 3 weeks.
- interventionNames
- Biological: PR-1 vaccine
Primary outcomes (2)
- measure
- Patient Immunologic Response
- timeFrame
- 29 weeks
- description
- Patients assessed after 4th vaccination for immunologic response categorized as 'Immunologic-Responders' or 'Non-Responders.' Immune response defined as an increase of ≥ 0.5 PR1-HLA-A2 tetramer cells/μl compared to the pre study absolute PR1-HLA-A2 tetramer cells/μl. Time period 29 weeks after study entry, with week 0 corresponding to 1st injection, and 8th injection thus being given at week 25, 29 weeks corresponds to 13 weeks after receipt of a 4th injection.
- measure
- Number of Patients With Clinical Response
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Must understand and voluntarily sign an informed consent form 2. Age \>/= 18 years at the time of signing the informed consent form 3. Must be able to adhere to the study visit schedule and other protocol requirements 4. HLA-A2 positive at one allele 5. Diagnosis of myelodysplastic syndrome (MDS) and must meet all the following criteria 6. French-American-British (FAB) Class Refractory anemia (RA), Refractory Anemia with Excess Blasts (RAEB), refractory anemia with ringed sideroblasts (RARS) 7. World Health Organization(WHO) Classification refractory anemia (RA), refractory anemia with ringed sideroblasts(RARS), refractory cytopenia with multilineage dysplasia (RCMD), refractory cytopenia with ringed sideroblasts (RCMD-RS) , refractory anemia with excess blasts type 1 (RAEB-1) 8. Less than 20% blasts on marrow aspirate 9. International Prognostic Scoring System (IPSS) risk groups Intermediate 1 or transfusion dependent low risk. 10. Both de novo and therapy related MDS are eligible 11. Eastern Cooperative Oncology Group (ECOG) performance status = 0 or 1 12. Women of childbearing potential must have a negative serum pregnancy test within 30 days of starting study drug. A woman of child-bearing potential is a sexually mature woman who has not undergone a hysterectomy or who has not been naturally postmenopausal for at least 24 consecutive months (i.e., who has had menses at any time in the preceding 24 consecutive months) 13. Male or female of child-bearing potential must agree to use adequate contraceptive methods 14. Serum bilirubin \< 2 mg/ml 15. Serum creatinine \</= 1.5 mg/ml 16. Serum ALT \< 2 x upper normal limit 17. anti-neutrophil cytoplasmic antibody (cANCA) negative 18. Not received specific therapy for MDS for 4 weeks. However, supportive therapy is permitted. Exclusion Criteria: 1. Marrow blasts on aspirate \>/= 20% 2. Blood blasts \> 1% 3. Inaspirable bone marrow 4. Myelosclerosis occupying \>30% of marrow space 5. Iron absence on marrow examination or transferrin saturation \<20% and serum ferritin \<50ng/ml 6. B-12 deficiency 7. Folate deficiency 8. History of immune related hematological disorder \[i.e.,immune thrombopenia purpura(ITP),autoimmune hemolytic anemia ( AIHA)\] 9. Other causes of cytopenia not related to MDS (i.e., GI blood loss) 10. Any serious medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from signing the informed consent form or that will place the subject at unacceptable risk if he/she were to participate in the study or confounds the ability to interpret the data 11. Prior allogeneic or syngeneic transplant 12. Prior solid organ transplant 13. Life expectancy severely limited by diseases other than MDS 14. Pregnant or lactating females 15. Prior vaccine therapy for MDS 16. Chronic use (\>2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to \>10 mg/day of prednisone) within 30 days of the first day of study drug treatment. (Topical and inhaled corticosteroids are permitted) 17. Prior history of malignancy other than MDS (except basal cell or squamous cell carcinoma or carcinoma in situ of the cervix or breast) unless the subject has been free of disease for \>/= 5 years 18. Known allergy to incomplete Freund's adjuvant 19. Experimental therapy, cyclosporine, antithymocyte globulin, or FK506 within 3 months of study entry 20. Treatment with androgenic hormones, danazol, colony stimulating factors, erythropoietin, thalidomide, arsenic trioxide or other agents used to treat MDS within four weeks of the first day of study treatment 21. refractory anemia with excess blasts in transformation (RAEB-t) (French-American British (FAB) criteria ) or refractory anemia with excess blasts type2 (RAEB-2) (World Health Organization (WHO) criteria) 22. Chloroma 23. Hypercalcemia 24. Progressive viral or bacterial infection. Patients are not eligible unless all infections are resolved and the patient has remained afebrile for seven days without antibiotics 25. Cardiac disease of symptomatic nature or cardiac ejection fraction \< 40% 26. Symptomatic pulmonary disease or FEV1, FVC and Carbon Monoxide Diffusing Capacity (DLCO) \</= 50% predicted 27. History of Wegener's Granulomatosis or vasculitis 28. History of HIV positivity or AIDS 29. Prior history of AML
References
Publications (0)
Data not yet available