Immune cells take on brain cancer in first human test
NCT ID NCT05651178
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial tests a new treatment for people with a rare and hard-to-treat type of lymphoma that has spread to the brain or spinal cord. The therapy uses the patient's own immune cells, modified to target two markers (CD19 and CD22) on cancer cells, and is given through a vein and directly into the spinal fluid. The main goals are to check safety and see if the treatment can shrink tumors, with 10 adults enrolled.
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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 10 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2022
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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:Subjects must meet all of the following criteria to be enrolled: * B cell malignancies patients with CD19 or CD22 positive, or CD19 and CD22 positive,include B cell acute lymphoblastic leukemia relapsed with central nervous system invasion and refractory/relapsed B cell lymphoma of central nervous system; * 18 to 70 years old (including cut-off value), Male and female; * Expected survival \> 12 weeks; * ECOG score 0-2; * Definitive diagnosed as central nervous system of B cell malignancies by Cerebrospinal fluid and/or MRI, PET/CT or other imaging examinations; * The venous access required for collection can be established and leukapheresis can be carried according to the judgement of investigators; * Liver, kidney and cardiopulmonary functions meet the following requirements: 1. The detection value of Creatinine within the normal range; 2. Left ventricular ejection fraction \> 50%; 3. Baseline oxygen saturation \> 92%; 4. Total bilirubin ≤ 2×ULN; 5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5×ULN; * Able to understand and sign the Informed Consent Document. Exclusion Criteria:Any one of the following conditions cannot be selected as a subject: * Malignant tumors other than B cell malignancies within 5 years prior to screening, in addition to adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, localized prostate cancer after radical resection, ductal carcinoma in situ after radical resection and thyroid cancer after radical resection; * Subjects with positive Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titer detection higher than or equal to the lower limit of detection; hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; human immunodeficiency virus (HIV) antibody positive; syphilis detection positive; * Any instability of systemic disease, including but not limited to unstable angina, cerebrovascular accident, or transient cerebral ischemic (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York heart association (NYHA) classification ≥ III), need drug therapy of severe arrhythmia, liver, kidney, or metabolic disease; * Active or uncontrollable infection requiring systemic therapy within 14 days prior to enrollment; * Pregnant or lactating woman, and female subject who plans to have a pregnancy within 1 year after cell transfusion, or male subject whose partner plans to have a pregnancy within 1 year after cell transfusion; * Received CAR-T treatment or other gene therapies before enrollment; * Subjects who are receiving systemic steroid treatment and requiring long-term systemic steroid treatment during the treatment as determined by the investigator before screening (except inhalation or topical use); And subjects treated with systemic steroids (except inhalation or topical use) within 72h prior to cell infusion; * The investigators consider other conditions unsuitable for enrollment.
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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.
Contacts and locations
Locations
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The Second Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
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Other studies related to the condition(s) this trial covers.
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