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Engineered immune cells take on Hard-to-Treat sarcomas

NCT ID NCT04433221

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 27, 2026 · Updated 3 times

Summary

This early-stage trial is testing a combination of specially engineered immune cells (CAR T cells) and a vaccine for people with sarcoma that has come back or spread. The goal is to see if the treatment is safe and can help shrink tumors. About 20 participants will receive the therapy along with low-dose chemotherapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CAR T cells and sarcoma vaccines
What this could lead to
If it works, this could point toward a new treatment option for people with advanced or returning sarcoma.
What could go wrong
This is a very early, small trial (20 people) testing safety first. The therapy may not shrink tumors, and side effects from the immune response could be serious.

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.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2027

An estimate. Start dates often move.

Expected to finish

Dec 2029

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

1 year to 75 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. Stage Ⅲ,Ⅳ sarcoma patients or recurrent sarcoma patients; 2. Age: ≥ 6 months and ≤80 years of age at the time of enrollment; 3. At least 2 weeks since the last standard chemotherapy or radiotherapy and immunosuppressive therapy such as steroid hormone before enrollment; 4. Side effects of chemotherapy have been well managed; 5. Confirmed malignant cell expression of CART target antigens by IHC or flow 6. Karnofsky /jansky score of 50% or greater; 7. Expected survival \> 8 weeks; 8. ANC≥ 1×10\^6/L,PLT ≥ 1×10\^8/L; 9. Pulse oximetry of≥90% on room air; 10. Adequate hepatic function, defined as aspartate aminotransferase(AST)\< 5 times upper limit of normal(ULN),serum bilirubin \< 3 times ULN; 11. Adequate renal function, defined as serum creatinine less than 2 times ULN, if serum creatinine more than 1.5 times ULN, creatinine clearance rate test is needed; 12. Patients must have sufficient autologous CART cells at does greater than 0.5x10\^6 cells/kg body weight; 13. Sign an informed consent and assent. Exclusion Criteria: 1. The disease is progressing rapidly; 2. The patient is receiving therapy of other new drugs and under evaluation; 3. Evidence of tumor potentially causing airway obstruction; 4. Epilepsy history or other CNS diseases; 5. Patients who need immunosuppressive drugs; 6. History of long QT syndrome or severe heart diseases; 7. Uncontrolled active infection; 8. Active hepatitis B virus, hepatitis C virus or HIV infection; 9. Receiving systemic corticosteroid 2 weeks before enrollment except for inhaled steroids; 10. Previous treatment with any gene therapy; 11. Creatinine\>2.5mg/dl or ALT/AST\>3 times normal or bilirubin\>2.0 mg/dl; 12. Patients who have other uncontrolled diseases such as obstruction of lung function would preclude participation as outlined; 13. Pregnant or lactating women; 14. Patients previously experienced toxicity from cyclophosphamide and doxorubicin; 15. Patients who have CNS sarcoma; 16. In condition that may bring risks to subjects or interference to clinical trials.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Shenzhen Geno-Immune Medical Institute

    Shenzhen, Guangdong, 518000, China

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