Clinical trial · Interventional
Combination Immunotherapy of GM.CD40L Vaccine With CCL21 in Lung Cancer
A Randomized Phase I/II Trial Using a GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) Vaccine in Combination With CCL21 for Patients With Stage IV Adenocarcinoma of the Lung
- 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 find out what effects (good and bad) a tumor vaccine used in combination with GM.CD40L and CCL21 have on the patient and their cancer. We also want to find out if the vaccine and the drugs can boost the immune system of these patients and how their immune system reacts, both before and after the vaccine treatment.
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 |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Phase I - GM.CD40L.CCL21 Vaccinations | Biological | — | UNRESOLVED |
| Phase II - GM.CD40L.CCL21 Vaccinations | Biological | — | UNRESOLVED |
| Phase II - GM.CD40L cells Vaccinations | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase I Vaccinations
- description
- Participants enrolled in the Phase I trial will receive GM.CD40L.CCL21 vaccinations on 3 occasions, at 2 week intervals. Note for the phase I portion: the use of steroid medication is to be avoided for 4 weeks prior to the initiation of vaccine therapy and during the vaccine treatment period.
- interventionNames
- Biological: Phase I - GM.CD40L.CCL21 Vaccinations
- type
- ACTIVE_COMPARATOR
- label
- Phase II Arm A Vaccinations
- description
- Arm A participants will receive GM.CD40L cells vaccinations on 3 occasions, at 2 week intervals. Note on either Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period.
- interventionNames
- Biological: Phase II - GM.CD40L cells Vaccinations
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed metastatic adenocarcinoma of the lung * Patients must have received and completed first line therapy * Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1 * No external beam radiation therapy within 2 weeks of first vaccine administration * No stereotactic radiation therapy within 3 days of first vaccine * No targeted therapy within 2 weeks of first vaccine administration * No immunomodulatory therapy within 2 weeks of first vaccine administration * No chemotherapy within 4 weeks of first vaccine administration * During Screening period, no steroid therapy within 4 weeks of first vaccine administration * Patient's written informed consent * Adequate organ function (measured within a week of beginning treatment): * White blood count (WBC) \> 3,000/mm³ and absolute neutrophil count (ANC) \>/= 1500/mm³ * Platelets \> 100,000/mm³ * Hematocrit \> 25% * Bilirubin \< 2.0 mg/dL * Creatinine \< 2.0 mg/dL, or creatinine clearance \> 60 mL/min * Patients will be tested for HLA-A0201 as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen; however this result will not be an inclusion criterion. * Measurable metastatic tumor as defined by standard Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Lesions must be accurately measured in at least one dimension with the longest diameter ≥20 mm. With spiral computed tomography (CT) scan, lesion must be ≥10 mm in at least one dimension. Exclusion Criteria: * Symptomatic brain metastasis or Uncontrolled central nervous system (CNS) metastasis will not be permitted. * Any acute medical problems requiring active intervention * Current corticosteroid (other than replacement doses in patients who are hypo-adrenal) or other immunosuppressive therapy * Any other pre-existing immunodeficiency condition (including known human immunodeficiency virus \[HIV\] infection) * Any known pre-existing autoimmune disorder * History of a second malignancy within the previous 2 years (except non-melanoma skin cancer and cervical in-situ) * Patients who have had major surgery without full recovery or major surgery within three weeks of the start of vaccine treatment * Pregnant or lactating women: Patients in reproductive age must agree to use contraceptive methods for the duration of the study (\*A pregnancy test will be obtained before treatment). * Eastern Cooperative Oncology Group (ECOG) performance status of 2, 3, or 4 * Patients with other significant diseases or disorders that, in the Investigator's opinion, would exclude them from the study. * Patients who at the discretion of the investigator are deemed to have rapidly progressive disease
References
Publications (0)
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