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CancerPhase 1/2NCT03535246

Immunotherapy Based on Tumor Associated Antigen-specific Immune Effector Cells

A Phase 1/2 study testing Engineered Immune Cells in people with Cancer, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objectives are to evaluate the safety and efficacy of infusion of autologous tumor associated antigen-specific engineered immune effector cells (EIE). Read more about this study

Who is it for?
Ages 1 year to 80 years
Conditions the study is for
Cancer
What is being tested?
Engineered Immune Cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 Jul 2025to 31 Jul 2026
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 year to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 1. Written, informed consent obtained prior to any study-specific procedures. 2. The results of immune staining of the patient's cancer specimens positive for any one or more of tumor-associated antigens, such as GD2, mesothelin, P16, MMP, Melan A, MAGE A1, MAGE A3, and MAGE A4.
  • 3. Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2. 4. Life expectancy ≥ 3 months. 5. Able to comply with the protocol. 6. Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV.
  • 7. Not pregnant, and on appropriate birth control if of childbearing potential.
  • 8. Adequate bone marrow reserve with
  • absolute neutrophil count (ANC) ≥ 1000/mm3.
  • Platelets ≥100,000/mm3. 9. Adequate renal and hepatic function with
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  • Serum creatinine ≤ 2 x upper limit of normal (ULN).
  • Serum bilirubin ≤ 2 x ULN.
  • aspartate aminotransferase (AST)/ALT ≤ 2 x ULN.
  • Alkaline phosphatase ≤ 5 x ULN.
  • Serum bilirubin. 2.0 is acceptable in the setting of known Gilbert's syndrome.

Who cannot join

  • 1. The results of immune staining of the patient's tumor-associated antigens are all negative.
  • 2. Previous experience of other cell therapy. 3. Participation in any other cell therapy protocols within one year. 4. Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug.
  • 5. Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).
  • 6. Pregnant or lactating females. 7. Unable to comply with the trial related requirement. 8. Inadequate bone marrow function:
  • Absolute neutrophil count < 1.0 x 10e9/L.• Platelet count < 100 x 10e9/L.• Hb < 9 g/dL.
  • Inadequate liver and renal function:
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  • 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 (or > 5 x ULN in case of liver metastases or > 10 x ULN in case of bone metastases).
  • 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.
  • 9. Serious active infection requiring i.v. antibiotics at during screening. 10. Subject infected with HIV (HIV antibody positive), Treponema pallidum antibody positive or TB culture positive.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Shenzhen Geno-immune Medical Institute

    Shenzhen, Guangdong, 518000

Other trials in China

About this study

Official title: Tumor Associated Antigen-specific Engineered Immune Effector Cells (EIE) Against Cancer

The primary objectives are to evaluate the safety and efficacy of infusion of autologous tumor associated antigen-specific engineered immune effector cells (EIE).

Read the detailed description

Malignant tumor is still a major challenge in medicine and requires technology breakthrough, and its mortality rate is the highest among all diseases. World Health Organization and the American Cancer Association expect about 12 million new cancer patients worldwide each year, with about 8 million cancer deaths (20 thousand cancer deaths per day). At present, more than 20 million people are suffering from cancer, and this figure will increase to 75 million in 2030. In Asia, the incidence of cancer is expected to rise by 60% in 2020, and the number of cancer related deaths will reach 7 million annually in 2030. The incidence of lung, Intestine, breast, prostate and gastric cancer is high, and lung, Intestine, breast and liver cancer are the main causes of cancer related deaths in Asia.

Adoptive immunotherapy based on cytotoxic T lymphocytes reactive with specific antigens has proven to be effective. In vitro induction of tumor antigen-specific immune cells and engineering of target specific immune cells have great potential for cancer eradication. The study aims to evaluate the safety and efficacy of ex vivo manipulated EIE cells including chimeric antigen receptor (CAR) modified immune cells in treating cancer. The primary study objectives are to evaluate the safety of the investigational product, autologous EIE cells, to subjects by intravenous and intratumoral injection. The secondary study objectives are (1) to evaluate the success rate of generating autologous EIE cells ex vivo, and (2) to determine the anti-cancer efficacy of the EIE cells.

Conditions
Cancer
Being tested
Engineered Immune Cells
Keywords
immunotherapy, T cell, Cancer, Gene therapy
Medical subject headings
Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Engineered Immune CellsBiological

    Engineered immune effector cells (EIE)

Study groups in NCT03535246
Study groupRoleWhat they receive
Single armExperimentalEIE cells to treat cancer.
Receives: Biological: Engineered Immune Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. percentage of adverse effects after EIE cell injection

    To assess the safety of autologous EIE cells in vivo. The percentage of patients who have adverse effects will be evaluated by using the NCI CTCAE V4.0 criteria.

    Measured: up to one month

Secondary outcomes (3)

  1. Rate of successful EIE generation

    The percentage of successful EIE generation, which are derived from subjects and pass the safety test after standard culture procedures, viable for at least one preparation, will be evaluated.

    Measured: up to one month

  2. Ability of EIE cells to induce anti-cancer reaction

    measurement of TAA concentration in blood sample

    Measured: after 1 month from EIE cells infusion until 12 months after infusion

  3. Ability of EIE cells for anti-cancer reaction

    Objective response (complete response (CR) + partial response (PR)) was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria. CR is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

    Measured: after 1 month from EIE cells infusion until 24 months after infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 May 2018
  2. Study start1 Jul 2025
  3. Primary completion1 Jul 2026
  4. Study completion31 Jul 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03535246
Sponsor's protocol ID
GIMI-IRB-18001
Status last verified
Aug 2026
First submitted
10 May 2018
Last updated
24 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Engineered Immune Cells in people with Cancer, run by Shenzhen Geno-Immune Medical Institute at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early. Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

percentage of adverse effects after EIE cell injection (time frame: up to one month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03535246.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.

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Clinical Trial NCT03535246 | AzTrials