In-Body CAR-T: could this be the future of blood cancer treatment?
NCT ID NCT07362602
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a new type of CAR-T therapy for B-cell blood cancers like lymphoma and leukemia. Instead of removing a patient's immune cells, modifying them in a lab, and infusing them back, this drug delivers genetic instructions directly into the body using tiny fat particles (LNPs). The goal is to reprogram the patient's own T cells to attack cancer cells marked by CD20. The study will enroll 47 adults to check safety and find the right dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- mRNA-LNP in vivo CAR-T drug targeting CD20
- What this could lead to
- If successful, this could lead to a simpler, faster, and more affordable CAR-T therapy for B-cell blood cancers, avoiding the need to remove and modify cells outside the body.
- What could go wrong
- This is a very early (Phase 1) exploratory study with only 47 participants. It may not show strong effectiveness, and safety in humans is still unknown. The approach is novel and unproven in clinical settings.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 47 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
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 70 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 range of 18-70 years old, gender not limited; * 2\. Expected survival time exceeds 12 weeks; * 3\. Diagnosed with blood system tumors such as CD20+B-cell lymphoma or lymphocytic leukemia and meeting the corresponding previous treatment requirements; * 4\. There are assessable lesions (applicable only to lymphoma patients); * 5\. The physical fitness status score of the Eastern Cancer Collaboration Group (ECOG) is 0 or 1 point; Before screening (at baseline), corresponding requirements should be met; * 7\. Male and female patients of appropriate age must use reliable methods of contraception before entering the trial, during the research process until 30 days after discontinuation of medication; Reliable contraceptive methods will be determined by the primary researchers or designated personnel; * 8\. Those who can understand this experiment and have signed the informed consent form. Exclusion Criteria: * 1\. Accompanied by other uncontrolled malignant tumors; * 2\. Received chimeric antigen receptor therapy or other transgenic T cell therapy within 6 months; * 3\. Known history of HIV or hepatitis B (HBsAg positive and HBV DNA reaching the detection limit) or hepatitis C virus (anti HCV positive) infection; * 4\. Participants with a history of CNS lymphoma, malignant cells in cerebrospinal fluid, or brain metastases; * 5\. Participants with atrial or ventricular involvement; * 6\. Emergency treatment is required due to the impact of tumor masses, such as intestinal obstruction or vascular compression; * 7\. Suffering from serious diseases such as coronary heart disease, angina pectoris, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage, poorly controlled hypertension, or other uncontrolled active diseases that hinder participation in the trial; * 8\. Unstable pulmonary embolism, deep vein thrombosis, or other major arterial/venous thromboembolism events occurred within 30 days prior to enrollment. If receiving anticoagulant therapy, the treatment dose of participants must reach a stable level before enrollment; * 9\. For those who have been using immunosuppressants for a long time after organ transplantation, except for recent or current inhaled corticosteroid therapy; * 10\. Any pregnant or breastfeeding woman, or participant who plans to conceive during or within 18 months after treatment; * 11\. Within 14 days prior to enrollment, there is an active or uncontrollable infection that requires systemic treatment (excluding simple urinary tract infections or upper respiratory tract infections). * 12\. The researcher believes that there are any other factors that are not suitable for the study participants to enter this trial.
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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 official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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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.
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Other studies related to the condition(s) this trial covers.
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