RecruitingPhase 1/2

GD2/CD56 Bi-specific CAR-T Cell Therapy

China60 participantsStarted 2026-06-01

Plain-language summary

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of anti-GD2/CD56 bi-specific CAR-T cell therapy in patients with GD2 and/or CD56 positive cancer. Another goal of the study is to learn more about the function of the anti-GD2/CD56 bi-specific CAR-T cells and their persistency in patients.

Who can participate

Age range

1 Year – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients with tumors received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent.
. The expression status of GD2 or CD56 antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by GD2 and CD56 antibody staining results based on immunohistochemistry or flow cytometry analyses.
. Body weight greater than or equal to 10 kg.
. Age: ≥1 year and ≤ 75 years of age at the time of enrollment.
. Life expectancy: at least 8 weeks.
. Prior Therapy:
. Participant must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of patients with adverse events.

Timeframe: 6 months

Trial details

NCT IDNCT05437328

SponsorShenzhen Geno-Immune Medical Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-31

Contact for this trial

Lung-Ji Chang, PhD

+86 0755-86573763 c@szgimi.org

View on ClinicalTrials.gov More Malignant Disease trials

Plain-language summary

Who can participate

Age range

1 Year – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Patients with tumors received standard first-line therapy and have been judged to be non-resectable, metastatic, progressive or recurrent.
. The expression status of GD2 or CD56 antigens in the tumor tissue will be determined for eligibility. Positive expression is defined by GD2 and CD56 antibody staining results based on immunohistochemistry or flow cytometry analyses.
. Body weight greater than or equal to 10 kg.
. Age: ≥1 year and ≤ 75 years of age at the time of enrollment.
. Life expectancy: at least 8 weeks.
. Prior Therapy:
. Participant must not have received hematopoietic growth factors for at least 1 week prior to mononuclear cells collection.

GD2/CD56 Bi-specific CAR-T Cell Therapy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

GD2/CD56 Bi-specific CAR-T Cell Therapy

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Contact for this trial

Exclusion criteria