Engineered immune cells take aim at stubborn blood cancers
NCT ID NCT04033302
First seen Jun 27, 2026 · Last updated Aug 27, 2026 · Updated 2 times
Summary
This study tests a new type of immunotherapy called CAR-T cells that are designed to recognize and attack cancer cells carrying a protein called CD7. It includes people with several blood cancers, such as T-cell acute lymphoblastic leukemia and acute myeloid leukemia. The goal is to see if the treatment is safe and can shrink tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD7-specific CAR-T cells
- What this could lead to
- If successful, this could offer a new treatment option for people with hard-to-treat blood cancers that express the CD7 protein.
- What could go wrong
- This is an early-phase trial with only 30 participants, so results may not apply broadly. CAR-T therapy can cause severe side effects like cytokine release syndrome.
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
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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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
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6 months to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Age older than 6 months. 2. Confirmed expression of CD7 or additional surface antigens in the cancer cells by immuno-histochemical staining or flow cytometry. 3. Karnofsky performance status (KPS) score is higher than 80 and life expectancy \> 3 months. 4. Adequate bone marrow, liver and renal function as assessed by the following laboratory requirements: cardiac ejection fraction ≥ 50%, oxygen saturation ≥ 90%, creatinine ≤ 2.5 × upper limit of normal, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal, total bilirubin ≤ 2.0mg/dL. 5. Hgb≥80g/L. 6. No cell separation contraindications. 7. Abilities to understand and the willingness to provide written informed consent. Exclusion Criteria: 1. Sever illness or medical condition, which would not permit the patient to be managed according to the protocol, including active uncontrolled infection. 2. Active bacterial, fungal or viral infection not controlled by adequate treatment. 3. Known HIV or hepatitis C virus (HCV) infection. 4. Pregnant or nursing women may not participate. 5. Use of glucocorticoid for systemic therapy within one week prior to entering the trial. 6. Previous treatment with any gene therapy products. 7. Patients, in the opinion of investigators, may not be able to comply with the study.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000, China
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