Clinical trial · Interventional
Clinical Study of DC Plus CIK for Patients With Relapse Acute Leukemia After Allo-HSCT
Clinical Study of Genetically Modified Dendritic Cells Combining to Cytokine-Induced Killer Cells for Patients With Relapse Acute Leukemia After Allo-HSCT
- 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)
Allogeneic hematopoietic cell transplantation(Allo-HSCT) is currently an effective treatment for Acute leukemia (AL). Relapse after transplantation, being a main obstacle for patient survival, is so far treated by second transplantation and donor leukocyte infusion (DLI), which seems to have high risk and low survival. Need for a new medication on relapse is urgent. The immunotherapy using Dendritic cells (DCs) combined with cytokine induced killer (CIK) cells holds promise for the adjuvant treatment of AL to eradicate or control residual disease. This randomized study was conducted to evaluate the feasibility and effective of genetically modified DCs combining to CIK immunotherapy in relapse AL after allo-HSCT.
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 |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Donor leukocyte infusions (DLI) | Biological | — | UNRESOLVED |
| Genetically modified DCs plus CIK cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Genetically modified DCs plus CIK cells
- description
- Patients received four subcutaneous injections of 2-5×10e7 cells of DCs at the groin, axilla, and neck respectively on days 7, 9, 11, and 13 and i.v. infusions of 2-15×10e9 CIK on days 11 and 13 per cycle. The cycle was repeated until Wilms' tumor 1(WT1) turned negative by polymerase chain reaction(PCR) or graft-versus-host disease(GVHD) appeared.
- interventionNames
- Biological: Genetically modified DCs plus CIK cells
- type
- ACTIVE_COMPARATOR
- label
- Donor leukocyte infusions (DLI)
- description
- Patients received DLI at a dose of 2×10e7/kg, 5×10e7/kg and 1×10e8/kg cluster of differentiation 3(CD3)+ cells at months 1, 2 and 3 respectively unless GVHD appeared.
- interventionNames
- Biological: Donor leukocyte infusions (DLI)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 61 Years
Show eligibility criteria text
Inclusion Criteria: * AL patients according to the WHO criteria * expected survival duration of more than 3 months * age between 8 and 61years Exclusion Criteria: * underlying autoimmune disease * positive serology for HIV infection * chronic active hepatitis
References
Publications (1)
- DERIVEDWang D, Huang XF, Hong B, Song XT, Hu L, Jiang M, Zhang B, Ning H, Li Y, Xu C, Lou X, Li B, Yu Z, Hu J, Chen J, Yang F, Gao H, Ding G, Liao L, Rollins L, Jones L, Chen SY, Chen H. Efficacy of intracellular immune checkpoint-silenced DC vaccine. JCI Insight. 2018 Feb 8;3(3):e98368. doi: 10.1172/jci.insight.98368. eCollection 2018 Feb 8. PMID 29415891