Clinical trial · Interventional
Autologous Dendritic Cells in Treating Patients With Metastatic Kidney Cancer
A Phase I, Open Label, Dose Escalation and Cohort Expansion Study to Evaluate the Safety and Immune Response to Autologous Dendritic Cells Transduced With Ad-GMCAIX in Patients With Metastatic Renal Cell Carcinoma
NCT01826877CI-TRIAL-00053070completedPhase 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)
This phase I trial studies the side effects and best dose of autologous dendritic cells in treating patients with metastatic kidney cancer. Vaccines made from a person's tumor cells and white blood cells may help the body build an effective immune response to kill tumor cells.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Clear Cell Renal Cell Carcinoma | Clear Cell Renal Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IV Renal Cell Cancer | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| AdGMCAIX-transduced autologous dendritic cells | Biological | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| therapeutic autologous dendritic cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (autologous dendritic cells)
- description
- Patients receive AdGMCAIX-transduced autologous dendritic cells ID on days 1, 15, and 29.
- interventionNames
- Biological: AdGMCAIX-transduced autologous dendritic cells
- Biological: therapeutic autologous dendritic cells
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Incidence of adverse events including all grade 3 and grade 4 adverse events regardless of causality, treatment-related adverse events, dose limiting toxicities (DLT), and adverse events leading to discontinuation of study treatment
- timeFrame
- Up to day 57
- description
- Graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed clear cell renal cell carcinoma (ccRCC); pathology report from the original diagnosis of renal cell carcinoma is acceptable; the component of conventional clear cell type \> 50% is mandatory * Evidence of metastatic disease with measurable lesion(s) as defined by RECIST guideline version 1.1 to permit tumor response evaluation; subjects with unresected primary tumors may be enrolled as long as evidence of measurable metastatic disease is also present * Signed informed consent * Eastern Cooperative Oncology Group (ECOG) =\< 1 * Expected life expectancy \>= 6 months * Serum creatinine \< 2 mg/dL * Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< 2.5 X upper limit of normal (ULN) * Total bilirubin \< 2 X ULN (except for subjects with documented Gilbert's syndrome who can have total bilirubin \< 3.0 mg/dl) * Hemoglobin \>= 10 g/dL * Absolute neutrophil count \>= 1.5 X 10\^9 cells/L * Platelets \>= 100 X 10\^9/L * Having recovered from prior surgery, radiation, chemotherapy (cytotoxic and noncytotoxic) to toxicity grade =\< 1 or returned to baseline; previous treatment with immunotherapies, cytotoxic drugs, or other targeted agents is permitted; if cytotoxic chemotherapy was previously received, the last dose must be \>= 1 month before leukapheresis; for other agents, the last dose must be \>= 14 days before leukapheresis * Negative serum pregnancy test within 7 days prior to enrollment in female subjects with reproductive potential Exclusion Criteria: * Rapidly progressing cancer likely to require palliative systemic intervention within 8 weeks after study entry * Presence of untreated/active central nervous system (CNS) metastases * For subjects with metastatic RCC who have had no prior systemic treatment for RCC and are considered a poor risk according to Motzer criteria, defined by having \>= 3 of the following 5 risk factors for short survival: Karnofsky performance score \< 80%, lactate dehydrogenase (LDH) \> 1.5 X of ULN, hemoglobin \< lower limit of normal (LLN), corrected serum calcium \> 10 mg/dL (2.5mM), a time from initial diagnosis of RCC to initiation of systemic therapy of \< 1 year * Non-clear cell or predominantly (\> 50%) sarcomatoid histology * Concurrent major medical conditions, such as uncontrolled hypertension, diabetes mellitus, ischemic heart disease, chronic obstructive pulmonary disease, autoimmune disease, adrenal insufficiency, or prior allogeneic organ transplant requiring chronic immunosuppressive therapy, including systemic glucocorticoid treatment or replacement therapy * Active or chronic systemic infection, including viral hepatitis, human immunodeficiency virus (HIV), mycobacteria, tuberculosis (TB), or other opportunistic infections * Having received systemic immune suppressive therapy within 30 days prior to leukapheresis * Having received an investigational agent within 30 days prior to the first dose of study treatment * Female subjects who are lactating, pregnant or both male and female subjects with reproductive potential who refuse to practice medically accepted methods for contraception over the period from study consent to 90 days following the last dose of study treatment * Other malignancy within 3 years, except for adequately treated non-melanoma skin cancer, non-invasive cancers such as cervical or breast carcinoma in situ, or superficial bladder cancer without local recurrence * Social or psychological conditions that the investigator judges may compromise study compliance
References
Publications (1)
- DERIVEDFaiena I, Comin-Anduix B, Berent-Maoz B, Bot A, Zomorodian N, Sachdeva A, Said J, Cheung-Lau G, Pang J, Macabali M, Chodon T, Wang X, Cabrera P, Kaplan-Lefko P, Chamie K, Belldegrun AS, Pantuck AJ, Drakaki A. A Phase I, Open-label, Dose-escalation, and Cohort Expansion Study to Evaluate the Safety and Immune Response to Autologous Dendritic Cells Transduced With AdGMCA9 (DC-AdGMCAIX) in Patients With Metastatic Renal Cell Carcinoma. J Immunother. 2020 Nov/Dec;43(9):273-282. doi: 10.1097/CJI.0000000000000336. PMID 32925563