Lung cancer cell therapy trial pulled before it started
NCT ID NCT03353428
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial aimed to test a new treatment for advanced lung cancer using specially grown immune cells (LC-CTLs) designed to attack cancer. The study was withdrawn before enrolling any participants, so no results are available. It was planned as an early safety and lab-effectiveness study.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lung cancer specific cytotoxic lymphocytes (LC-CTLs)
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Started
-
Nov 2017
- Expected to finish
-
Dec 2020
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 70 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Written, informed consent obtained prior to any study-specific procedures. 2. Age older than 18 years. 3. Patients with refractory, relapsed, metastatic, advanced lung cancer confirmed by histology and biopsy. 4. Eastern Cooperative Oncology Group (ECOG) PS of 0 or 1. 5. Expected survival ≥ 12 weeks. 6. Not pregnant, and on appropriate birth control if of childbearing potential. 7. Initial hematopoietic reconstitution with * neutrophils (ANC) ≥ 1,000/mm\^3; * platelet (PLT) ≥ 100,000/mm\^3. 8. Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with * serum creatinine ≤ 2×ULN; * serum bilirubin ≤ 2×ULN; * AST/ALT ≤ 2×ULN; * ALKP ≤ 5×ULN; * serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome. 9. Human immunodeficiency virus (HIV) and Hepatitis C virus (HCV) test were negative. Exclusion Criteria: 1. Have occurred in 5 years or are currently suffering from other cancers, except for cured cervical cancer, non-melanoma skin cancer and superficial bladder cancer. 2. Previous exposure to mouse CEA antibody. 3. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study. 4. Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations). 5. Pregnant or lactating females. 6. Inadequate bone marrow function with * absolute neutrophil count \< 1,000/mm\^3; * platelet count \< 100,000/mm\^3; * Hb \< 9 g/dL. 7. Inadequate liver and renal function with * serum (total) bilirubin \> 1.5 x ULN; * AST \& ALT \> 2.5 x ULN (\> 5 x ULN in patients with liver metastases); * alkaline phosphatase \> 2.5 x ULN; * serum creatinine \>2.0 mg/dl (\> 177 μmol/L); * urine dipstick for protein uria should be \< 2+. Patients with ≥ 2+ proteinuria on dipstick urinalysis at baseline should undergo 24 hour urine collection and must demonstrate \< 1 g of protein/24 hr. 8. Serious active infection requiring i.v. antibiotics at during screening. 9. Subject infected with HCV (HCV antibody positive), HBV (HBsAg positive), HIV (HIV antibody positive), HTLV (HTLV antibody positive), Treponema pallidum antibody positive or TB culture positive.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000, China
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