Clinical trial · Interventional
PR1-Specific Cytotoxic T-Lymphocyte Infusion With Recurrent Chronic Myelogenous Leukemia (CML) After Allogeneic Hematopoietic Transplantation
A Phase I Study of PR1-Specific Cytotoxic T-Lymphocyte Infusion for Patients With Recurrent CML After Allogeneic Hematopoietic Transplantation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study failed to accrue any patients due to regulatory issues with PR1 vaccine and T cell production.
Summary
Brief summary (as posted)
Primary Objective: To determine the maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL) as treatment for relapsed or persistent chronic myelogenous leukemia (CML) after allogeneic hematopoietic transplantation from an HLA-matched related or unrelated donor. Secondary Objectives: 1. To evaluate the immunological response following PR1-CTL treatment 2. To evaluate the clinical efficacy by determining clinical, cytogenetic and molecular response rates within 6 months
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 |
|---|---|---|---|
| Chronic Myelogenous Leukemia | Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PR1-primed lymphocyte (PR1-CTL) Infusion | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- PR1-CTL
- description
- Two infusions of PR1-specific T lymphocytes (donor immune cells) 60 days apart. Starting infusion dose 1 x 106 nucleated cells/kg.
- interventionNames
- Biological: PR1-primed lymphocyte (PR1-CTL) Infusion
Primary outcomes (1)
- measure
- Maximally tolerated dose of donor PR1-specific cytotoxic T-lymphocytes (PR1-CTL)
- timeFrame
- Continuous reassessment, infusion day 0 and second infusion day 60+/- 7
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients with chronic myelogenous leukemia (CML) who have previously undergone allogeneic hematopoietic transplantation and have evidence of disease, as defined by a,b or c (a) \>5% Philadelphia chromosome positive cells on cytogenetic studies \>/= 3 months post-transplant 2. (b) For patients in cytogenetic remission post-transplant, molecular evidence of disease at any time, defined as recurrence of quantitative PCR positivity for bcr-abl after achieving a molecular remission confirmed by 2 assays, 3 months apart or sooner if clinically indicated; OR a \>10-fold increase in the relative expression of bcr-abl/abl detected and confirmed by a minimum of 2 consecutive PCR analysis, 3 months apart or sooner 3. (c) Molecular evidence of persistent disease on Real time PCR (bcr-abl/ abl x 100 of 0.05 and not declining) \>3 months post-transplantation after treatment with imatinib mesylate. 4. Patients must have an HLA compatible related or unrelated donor capable of donating peripheral blood stem cells using apheresis techniques. This must be the same donor used for the original allogeneic hematopoetic transplantation. Patient must be HLA-A2 positive 5. ECOG performance status \< or = 2 6. Serum bilirubin \< or = 2 mg/dl 7. Serum transaminases \< 4 x normal 8. Serum creatinine \< or = 2 mg/dl 9. No active uncontrolled infection 10. HIV negative 11. No acute and/or chronic GVHD requiring systemic steroid therapy 12. Patient is not pregnant or breast feeding. 13. Signed informed consent 14. Patients must be off all immunosuppressive medications for at least 2 weeks prior to study entry. Exclusion Criteria: None.
References
Publications (0)
Data not yet available