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Lung cancer cell therapy trial pulled before it started

NCT ID NCT03353428

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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 The study was withdrawn before enrolling any participants, so no results are available.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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.