Engineered immune cells take on relapsed blood cancers
NCT ID NCT07584889
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing a new type of CAR-T cell therapy, called CD19-CAR.p40-T, in 10 adults with B-cell lymphoma, acute lymphoblastic leukemia, or acute myeloid leukemia that has come back or not responded to treatment. Participants receive chemotherapy followed by an infusion of their own genetically modified immune cells designed to target and kill cancer cells. The study aims to first check safety, then see if the treatment shrinks tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CD19-CAR.p40-T cells (a type of genetically modified immune cell)
- What this could lead to
- If it works, this could offer a new treatment option for people with blood cancers that have not responded to standard therapies.
- What could go wrong
- This is a very early, small trial with only 10 participants, so results may not apply broadly. CAR-T therapy can cause serious 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 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Apr 2024
- Expected to finish
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Apr 2029
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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18 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 Subjects must meet all of the following criteria to be enrolled: 1. • Aged 18 to 75 years, male or female; 2. • Histologically or cytologically diagnosed with relapsed/refractory CD19-positive hematologic malignancy according to the 2022 World Health Organization (WHO) diagnostic criteria; 3. • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2; 4. • Life expectancy of at least 3 months; 5. • No contraindications to peripheral blood leukapheresis; 6. • CD19 expression on tumor cells confirmed by flow cytometry and/or immunohistochemistry; 7. • No severe cardiac, pulmonary, hepatic, or renal dysfunction; 8. • Able to understand and willing to provide written informed consent. Exclusion Criteria Subjects who meet any of the following criteria should be excluded from enrollment: 1. History of allergy to any component of the cellular product; 2. Complete blood count meeting any of the following criteria: white blood cell count (WBC) ≤1 × 10⁹/L, absolute neutrophil count (ANC) ≤0.5 × 10⁹/L, absolute lymphocyte count (ALC) ≤0.5 × 10⁹/L, or platelet count (PLT) ≤25 × 10⁹/L; 3. Laboratory abnormalities including, but not limited to, serum total bilirubin ≥1.5 mg/dL; serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 times the upper limit of normal; or serum creatinine ≥2.0 mg/dL; 4. Class III or IV cardiac insufficiency according to the New York Heart Association (NYHA) functional classification, or left ventricular ejection fraction (LVEF) \<50% by echocardiography; 5. Abnormal pulmonary function, with oxygen saturation \<92% on room air; 6. History of myocardial infarction, cardiac angioplasty or stent placement, unstable angina, or other clinically significant severe cardiac disease within 12 months prior to enrollment; 7. Grade 3 hypertension with poor blood pressure control despite medication; 8. History of traumatic brain injury, disturbance of consciousness, epilepsy, severe cerebral ischemia, or cerebral hemorrhagic disease; 9. Autoimmune disease, immunodeficiency, or other conditions requiring treatment with immunosuppressive agents; 10. Uncontrolled active infection; 11. Prior treatment with any CAR-T cell product or other genetically modified T-cell therapy; 12. Receipt of a live vaccine within 4 weeks prior to enrollment; 13. Positive test results for HIV, HBV, HCV, or TPPA/RPR, or HBV carrier status; 14. History of alcohol abuse, drug abuse, or psychiatric illness; 15. Participation in any other clinical study within 3 months prior to enrollment in this clinical study; 16. Female subjects who meet any of the following conditions: 1. Pregnant or breastfeeding; 2. Planning to become pregnant during the study; or 3. Of childbearing potential and unwilling or unable to use effective contraception; 17. Any other condition that, in the investigator's opinion, makes the subject unsuitable for participation in this 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 University General Hospital
RECRUITINGShenzhen, Other (Non U.s.), 518055, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Reprogrammed immune cells target CD30-Positive lymphoma in early trial
- Can a p53-Targeting drug boost chemotherapy in Hard-to-Treat blood cancers?
- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Engineered immune cells aim to wipe out stubborn leukemia
- Two-Drug combo targets leukemia that outsmarted its first treatment