Clinical trial · Interventional
Laboratory-Treated Autologous Lymphocytes, Aldesleukin, and GM-CSF in Treating Patients With Recurrent, Refractory, or Metastatic Non-Small Cell Lung Cancer
A Phase I Study of Anti-CD3 x Cetuximab-Armed Activated T Cells, Low Dose IL-2, and GM-CSF for EGFR-Positive, Advanced Non-Small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding ended
Summary
Brief summary (as posted)
RATIONALE: Giving autologous lymphocytes that have been treated in the laboratory with antibodies may stimulate the immune system to kill tumor cells. Aldesleukin may stimulate the lymphocytes to kill tumor cells. Colony-stimulating factors, such as GM-CSF, may increase the number of immune cells found in bone marrow or peripheral blood. Giving laboratory-treated autologous lymphocytes together with aldesleukin and GM-CSF may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of laboratory-treated autologous lymphocytes when given together with aldesleukin and GM-CSF in treating patients with recurrent, refractory, or metastatic non-small cell lung cancer. FUNDING SOURCE--FDA OOPD
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 |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| aldesleukin | Biological | Aldesleukin | ALIAS |
| EGFRBi-armed autologous activated T cells | Biological | — | UNRESOLVED |
| sargramostim | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- T-cells
- description
- EGFRBi-armed autologous activated T cells
- interventionNames
- Biological: EGFRBi-armed autologous activated T cells
- Biological: aldesleukin
- Biological: sargramostim
Primary outcomes (3)
- measure
- Safety
- timeFrame
- 4 weeks
- measure
- Maximum tolerated dose of EGFRBi-armed autologous activated T-cells
- timeFrame
- 4 weeks
- measure
- Determination of immunologic changes by evaluation of cytokine profiles obtained before and after stimulation with OKT3 in vitro
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Recurrent, refractory, or metastatic disease after ≥ 1 prior first-line regimen (chemotherapy or radiotherapy) * Documented EGFR-positive disease (any expression level) by immunohistochemistry (IHC) (may be based on archival sample) * Measurable or evaluable disease by radiograph, CT scan, MRI, and/or physical exam * Appropriate slides of the primary lesion must be available for review of IHC staining assessment by a central pathology team * No clinical evidence of active brain metastases * Patients with brain metastases are eligible provide they have received definitive radiotherapy or chemotherapy and/or have undergone surgical resection for brain metastases * No prior hematological malignancy PATIENT CHARACTERISTICS: * Karnofsky performance status (PS) 60-100% OR ECOG PS 0-2 * Life expectancy ≥ 3 months * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Granulocytes ≥ 1,000/mm\^3 * Platelet count ≥ 50,000/mm\^3 * Hemoglobin ≥ 8 g/dL * BUN ≤ 2.0 times normal * Serum creatinine ≤ 2.0 mg/dL * Bilirubin ≤ 1.5 times normal * SGOT ≤ 1.5 times normal (with or without liver metastases) * Hepatitis B surface antigen and HIV negative * LVEF ≥ 45 % at rest (by MUGA) * No evidence of depressed left ventricular function * FEV\_1, DLCO, and FVC ≥ 50% of the predicted value * No other malignancy, except for the following: * History of curatively treated in situ squamous cell carcinoma or basal cell carcinoma of the skin * History of other curatively treated malignancy (except those with a hematologic origin) for which the patient has remained in complete remission \> 5 years after completing therapy (as documented by history, physical exams, tumor markers, and radiology scanning) * No serious medical or psychiatric illness that would preclude giving informed consent or receiving intensive treatment * No recent myocardial infarction (within the past year) * No current angina/coronary symptoms requiring medications * No clinical evidence of congestive heart failure requiring medical management (irrespective of MUGA results) * No systolic blood pressure (BP) ≥ 130 mm Hg or diastolic BP ≥ 80 mm Hg * Patients with elevated BP must have it controlled by anti-hypertensive medications for at least 7 days prior to the first infusion PRIOR CONCURRENT THERAPY: * See Disease Characteristics * More than 4 weeks since prior chemotherapy or radiotherapy * At least 4 weeks since prior cetuximab or small molecule EGFR-inhibitors including, but not limited to, gefitinib or erlotinib hydrochloride * No concurrent radiotherapy * No concurrent steroids except for treatment of adrenal failure, septic shock, or pulmonary toxicity or hormones for non-disease-related conditions (e.g., insulin for diabetes)
References
Publications (0)
Data not yet available