Clinical trial · Interventional
Host Dendritic Cells in Allograft Patients
A Phase I Trial of Host Dendritic Cell Infusion After Allogeneic Stem Cell Transplant for Prevention or for Treatment of Relapsed Disease in Patients With Advanced Hematologic Malignancies
NCT00935597CI-TRIAL-00004072unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to assess preliminary efficacy and to determine the safety and feasibility of ex vivo generated dendritic cell (HDC) infusion with and without donor lymphocyte infusion (DLI) after allogeneic stem cell transplant (SCT). We also wish to establish the feasibility of apheresis shipment as well as vaccine shipment and stability in the population.
Conditions
Conditions (4)
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 Lymphocytic Lymphoma | — | UNRESOLVED | — |
| Hodgkin's Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
| Relapsed Non-Hodgkin's Lymphoma | Non-Hodgkin Lymphoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group 1
- description
- Patients with Minimal Residual Disease or Minimal Volume Relapse post allogeneic stem cell transplant will receive MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) by infusion
- interventionNames
- Biological: MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)
- type
- EXPERIMENTAL
- label
- Group 2
- description
- Patients with greater than Minimal Residual Disease or Minimal Volume Relapse post allogeneic stem cell transplant will receive MSSM/BIIR HDC Vax-001 (Host Dendritic Cells) by infusion in conjunction with donor lymphocyte infusion (DLI)
- interventionNames
- Biological: MSSM/BIIR HDC Vax-001 (Host Dendritic Cells)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18-70 * Ability to sign informed consent * ECOG performance status ≤3 * Life expectancy \> 6 months * Adequate cardiac function: MUGA or Echocardiogram demonstrating \>50% Ejection Fraction * Adequate pulmonary function with DLCO \> 50% * Adequate hepatic function * Bilirubin ≤ 1.5mg/dl * Alkaline phosphatase ≤5 times the upper limit of normal * Aspartate aminotransferase (AST) or serum glutamic-oxaloacetic transferase (SGOT) ≤ 3 times the upper limit of normal * Alanine aminotransferase (ALT) or serum glutamic pyruvic transaminase (SGPT) ≤ 3 times the upper limit of normal * Adequate renal function Estimated creatinine clearance \> 40ml/min * Diagnosis of one of the following * Non-Hodgkin's lymphoma excluding Follicular lymphoma and Marginal Zone Lymphoma * Hodgkin's lymphoma * Multiple myeloma * Chronic lymphocytic leukemia * Eligible for allogeneic stem cell transplant with identified HLA-identical sibling (6/6 HLA match) or volunteer unrelated donor (8/8 allele HLA-matched (A, B, Cw, DRB1) * Women of childbearing potential must have a negative serum pregnancy test prior to enrollment * Women of childbearing potential must use effective means of birth control throughout the study. * Men should not father a child while enrolled in the study. Effective means of birth control include condom, vasectomy or abstinence. Exclusion Criteria: * Malignancies other than melanoma within five years of study entry, except carcinoma in-situ of the cervix or basal/squamous cell skin cancers * Concurrent illnesses that would preclude survival \> 6 months other than the disease under study * Pregnancy or nursing * HIV infection * Treatment with prior donor lymphocyte infusion * Prior allogeneic stem cell transplant * History of autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis and thyroiditis * Active infections including fungal infections and viral hepatitis * GVHD greater than grade I GVHD of the skin Patient Exclusion Criteria for Part B (post Stem Cell Transplant) * Malignancies other than melanoma within five years of study entry, except carcinoma in-situ of the cervix or basal/squamous cell skin cancers * Concurrent illnesses that would preclude survival \> 6 months other than the disease under study. * Pregnancy or nursing * HIV infection * Treatment with prior donor lymphocyte infusion * Prior allogeneic stem cell transplant * More than 4 prior relapses * History of autoimmune diseases including systemic lupus erythematosus, rheumatoid arthritis and thyroiditis * Active infections including fungal infections and viral hepatitis * GVHD greater than grade I GVHD of the skin * No cytotoxics will be given within 4 weeks of administration of the investigational cell therapy * Patients cannot receive any investigational agents within 30 days prior to administration of the investigational cell therapy
References
Publications (0)
Data not yet available
No reference posted for this study.