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Ovarian CancerPhase 1/2NCT03184753

Genetically Modified T Cells Against Ovarian Cancer

A Phase 1/2 study testing OC-IgT cells in people with Ovarian 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 ovarian cancer immunogene-modified T cells (OC-IgT cells). Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
OC-IgT cells
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 May 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 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Written, informed consent obtained prior to any study-specific procedures.
  • Female patients ≥ 20 years.
  • Eastern Cooperative Oncology Group (ECOG) PS of 0, 1 or 2.
  • Life expectancy ≥ 3 months.
  • Able to comply with the protocol.
  • Histologically confirmed and documented high risk International Federation of Gynecology and Obstetrics (FIGO): Stage III-IV.
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  • Complete remission after salvage treatment for first recurrence.
  • Not pregnant, and on appropriate birth control if of childbearing potential.
  • Adequate bone marrow reserve with ·absolute neutrophil count (ANC) ≥ 1000/mm3.
  • ·Platelets ≥100,000/mm3.
  • Adequate renal and hepatic function with ·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.Patients with:
  • Non-epithelial ovarian cancer.
  • Ovarian tumors with low malignant potential (i.e. borderline tumors).
  • Synchronous primary endometrial carcinoma and ovarian cancer. 2.Patients with evidence of abdominal free air not explained by paracentesis or recent surgical procedure (prior, current or planned treatment).
  • Previous experience of gene-engineered T cell therapy 4.Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in this study.
  • 5.Minor surgical procedures within 2 days prior to Day 0 (including central venous access device placement for chemotherapy administration, tumor biopsies, needle aspirations).
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  • 6.Pregnant or lactating females. 7.Inadequate bone marrow function:
  • ·Absolute neutrophil count < 1.0 x 109/L.
  • Platelet count < 100 x 109/L.
  • Hb < 9 g/dL. 8. Inadequate liver and renal function:
  • 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: Innovative Treatment of Ovarian Cancer Based on Immunogene-modified T Cells (IgT)

The primary objectives are to evaluate the safety and efficacy of infusion of autologous ovarian cancer immunogene-modified T cells (OC-IgT cells).

Read the detailed description

Ovarian cancer (OC) is a cancer that forms in or on an ovary. The majority of OC arises from the epithelium (outer lining) of the ovary. In 2015 OC was found in 1.2 million women and resulted in 161,100 deaths worldwide. Among women it is the seventh-most common cancer and the eighth-most common cause of death from cancer. Treatment for OC consists of surgery, chemotherapy, radiotherapy and sometimes, novel immunotherapies. The best treatment options depend on many factors, including the type of OC, its stage and grade, as well as the general health of the patient.

Adoptive immunotherapy with cytotoxic T lymphocytes reactive with specific antigens has proven to be effective. Novel chimeric antigen receptor gene modified T cell (CART) based immunotherapy has demonstrated great successes in B cell malignancies. Here, the study aim is to evaluate the safety and efficacy of genetically engineered OC-specific and immune modulatory T cells in patients. The primary study objectives are to evaluate the safety of the investigational product, autologous OC-IgT cells, to subjects by IV and intratumoral injection. The secondary study objectives are (1) to evaluate the success rate of generating autologous OC-IgT cells in vitro, and (2) to determine the anti-OC efficacy of the OC-IgT cells.

Conditions
Ovarian Cancer
Being tested
OC-IgT cells
Keywords
Autologous, IgT, Ovarian Cancer, CART
Medical subject headings
Ovarian Neoplasms

What participants receive

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

  • OC-IgT cellsBiological

    Autologous human OC-IgT cells.

Study groups in NCT03184753
Study groupRoleWhat they receive
Single armExperimentalOC-IgT cells to treat ovarian cancer.
Receives: Biological: OC-IgT cells

What is being measured

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

  1. percentage of adverse effects after OC-IgT cells injection

    To assess the safety of autologous OC-IgT 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 OC-IgT generation

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

    Measured: up to one month

  2. Ability of OC-IgT cells to induce anti-ovarian cancer reaction

    measurement of CA125 concentration in blood sample

    Measured: after 1 month from OC-IgT cells infusion until 12 months after infusion

  3. Ability of OC-IgT cells for anti-ovarian 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 OC-IgT cell 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 posted14 Jun 2017
  2. Study start1 May 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
NCT03184753
Sponsor's protocol ID
GIMI-IRB-17002
Status last verified
Nov 2026
First submitted
4 Jun 2017
Last updated
3 Nov 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 OC-IgT cells in people with Ovarian 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 14 inclusion and 16 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 3 Nov 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 OC-IgT cells 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 NCT03184753.

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 3 Nov 2026.

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