Engineered immune cells target two cancer markers in new trial

NCT ID NCT05438368

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times

Summary

This study tests a new type of cell therapy called GD2/CD70 bi-specific CAR-T cells for people with cancers that have GD2 or CD70 markers on their tumors. The treatment involves taking a patient's own immune cells, modifying them to recognize and attack these markers, and infusing them back into the body. The goal is to see if this approach is safe and can shrink tumors in patients whose cancer has not responded to standard treatments.

What this could mean

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

Active substance
GD2/CD70 bi-specific CAR-T cells
What this could lead to
If successful, this approach could offer a new treatment option for patients with certain hard-to-treat cancers that express GD2 or CD70 markers.
What could go wrong
This is an early-phase trial with a small number of participants, so the treatment may not work for everyone and could cause significant side effects. Long-term effectiveness and safety are not yet known.

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 30 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Dec 2030

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. Patients with tumors received standard first-line therapy and judged to be non-resectable, metastatic, progressive or recurrent. 2. The expression status of GD2 or CD70 antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by GD2 and PMSA antibody staining results based on immunohistochemistry or flow cytometry analyses. 3. Body weight greater than or equal to 10 kg. 4. Age: ≥1 year and ≤ 75 years of age at the time of enrollment. 5. Life expectancy: at least 8 weeks. 6. Prior Therapy: There is no limit to the number of prior treatment regimens. Any grade 3 or 4 non-hematologic toxicity of any previous therapy must be resolved to grade 2 or less. 7. Participant must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection. 8. At least 7 days must have elapsed since the completion of therapy with a biologic agent, selected targeted agent or a metronomic non-myelosuppressive regimen. 9. At least 4 weeks must have elapsed since prior therapy that included a monoclonal antibody. 10. At least 1 week since any radiation therapy at the time of study entry. 11. Karnofsky/jansky score of 60% or greater. 12. Cardiac function: Left ventricular ejection fraction greater than or equal to 40/55 percent. 13. Pulse Ox greater than or equal to 90% on room air. 14. Liver function: defined as alanine transaminase (ALT) \<3x upper limit of normal (ULN), aspartate aminotransferase (AST) \<3x ULN; serum bilirubin and alkaline phosphatase \<2x ULN. 15. Renal function: Patients must have serum creatinine less than 3 times upper limit of normal. 16. Marrow function: White blood cell count ≥1000/ul, Absolute neutrophil count ≥500/ul, Absolute lymphocyte count ≥500/ul, Platelet count ≥25,000/ul (not achieved by transfusion). 17. Patients with known bone marrow metastatic disease will be eligible for study as long as they meet hematologic function criteria, and the marrow disease does not have hematologic toxicity. 18. For all patients enrolled in this study, themselves or their parents or legal guardians must sign an informed consent and assent. Exclusion Criteria: 1. Existing severe illness (e.g. significant cardiac, pulmonary, hepatic diseases, etc.) or major organ dysfunction, or greater than grade 2 hematologic toxicity. 2. Untreatable central nervous system (CNS) metastasis: Patients with previous CNS tumor involvement that has been treated and is stable for at least 6 weeks following completion of therapy are eligible. 3. Previous treatment with other genetically engineered GD2 or CD70-specific CAR T cells. 4. Active HIV, hepatitis B virus (HBV), hepatitis C virus (HCV) infection or uncontrolled infection. 5. Patients who require systemic corticosteroid or other immunosuppressive therapy. 6. Evidence of tumor potentially causing airway obstruction. 7. Inability to comply with protocol requirements. 8. Insufficient CAR T cells availability.

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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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