CAR T-Cell Therapy for Lung Cancer
This study is testing a new treatment called iC9.GD2.CAR.IL-15 T Infusion for people with lung cancer that has not responded to platinum-based chemotherapy and has been treated with PD-1/PD-L1 inhibitors. This treatment uses your own immune cells, called T-cells, which are specially modified to find and fight cancer. The main goal is to find out how safe iC9.GD2.CAR.IL-15 T Infusion is, how much can be given without too many side effects, and the highest dose that can be tolerated. We will be looking for side effects like cytokine release syndrome (CRS) and neurotoxicity in the first four weeks after treatment. You can join if you are an adult with extensive stage or stage IV non-small cell lung cancer.
- Study design
- This is a Phase 1, single-center study with 24 adult participants. It is an open-label study, meaning both you and your doctors will know what treatment you are receiving.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will track side effects like cytokine release syndrome and neurotoxicity for up to 4 weeks after treatment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Autologous CAR T-Cells Targeting the GD2 Antigen for Lung Cancer
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Jared Weiss · PRINCIPAL_INVESTIGATOR · [email protected]
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Number of participants with adverse eventUp to 4 weeks
The number of participants with adverse events (AE)s will be reported as a measure of the safety and tolerability of C9.GD2.CAR.IL-15 T. AEs will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0. Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate instrumental Activities of Daily Living (ADL). Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care ADL. Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
- Cytokine Release Syndrome (CRS)Up to 4 weeks
CRS will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) CRS Consensus Grading. Grade 1 - Mild (Symptomatic Management): Fever ≥38\^ o C, No hypotension, No hypoxia, Grade 2 - Moderate (Moderate Intervention): Fever ≥38\^ o C, Hypotension not requiring vasopressors, Hypoxia requiring low-flow nasal cannula (≤6 L/minute) or blow-by, Grade 3 - Severe (Aggressive Intervention): Fever ≥ 38\^ o C , Hypotension requiring a vasopressor with or without vasopressin, Hypoxia requiring high-flow nasal cannula (\>6 L/minute), facemask, nonrebreather mask, or Venturi mask, Grade 4 - Life-threatening (Life-sustaining intervention): Fever ≥38\^oC, Hypotension requiring multiple vasopressors (excluding vasopressin), Hypoxia requiring positive pressure (e.g. Continuous positive airway pressure, BiPAP, intubation, mechanical ventilation), Grade 5 - Death: Death.
- NeurotoxicityUp to 4 weeks
Neurotoxicity will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) Immune effector cell-associated neurotoxicity syndrome (ICANS) Consensus Grading criteria. ICANS grading criteria are outlined in the protocol on a scale from 1 (mild) to 4 (critical) based on the Immune Effector Cell-Associated Encephalopathy (ICE) Score. Grade 1:Score: 7-9 (mild impairment), Grade 2:Score: 3-6 (moderate impairment), Grade 3: Score: 0-2 (severe impairment), Grade 4: Score: Subject in critical condition, and/or obtunded and cannot perform an assessment of tasks.