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Experimental CAR-T therapy targets Hard-to-Treat brain cancer
NCT ID NCT07062627
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study is testing a new treatment called Anbal-cel for people with relapsed or refractory primary or secondary central nervous system lymphoma. Anbal-cel is a CAR-T cell therapy made from the patient's own immune cells. The study will enroll 12 participants to see if the treatment is safe and effective. Participants will receive a single infusion of Anbal-cel and be monitored closely for at least 7 days in the hospital.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Anbal-cel (a CAR-T cell therapy made from the patient's own immune cells)
- What this could lead to
- If successful, this could offer a new treatment option for patients with hard-to-treat central nervous system lymphoma that has come back or not responded to other therapies.
- What could go wrong
- This is a very small pilot study with only 12 participants, so results may not apply to everyone. CAR-T therapy can cause serious side effects like cytokine release syndrome and neurological problems.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2025
- Expected to finish
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Dec 2027
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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19 years and older
- 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. Individuals aged 19 years or older who voluntarily agree to participate in this clinical study and provide written consent. 2. Patients with recurrent/refractory B-cell lymphoma confirmed histologically according to the 2017 WHO classification, and who meet one of the following conditions: Primary central nervous system lymphoma (PCNSL) of the DLBCL subtype Secondary central nervous system involvement of DLBCL with no involvement outside the central nervous system 3. Patients who failed treatment with a previous regimen that included high-dose methotrexate or patients intolerant to high-dose methotrexate. 4. Patients who agree to provide tumor tissue. If a stored tumor tissue sample is available, it can be submitted only if it was collected within 6 months prior to participation in the clinical study and if no systemic anticancer treatment was administered after collection. If the stored tissue sample does not meet these conditions, tumor tissue must be obtained through a core needle biopsy or excisional biopsy during the screening period. If the investigator deems the biopsy to be medically unsafe for the patient, the decision on whether to enroll the patient in the clinical study can be made in consultation with the patient's clinical physician. 5. Individuals with an ECOG performance status score of 2 or lower at the time of screening. 6. Individuals with appropriate renal and liver function confirmed by laboratory test results: Total Bilirubin ≤2.0 mg/dL (for individuals with Gilbert-Meulengracht syndrome: total bilirubin ≤3.0 × upper limit of normal (ULN), direct bilirubin ≤1.5 x ULN) Aspartate transaminase (AST) and alanine transaminase (ALT) ≤3 × ULN (if liver metastasis is confirmed: AST, ALT ≤5 × ULN) Serum creatinine ≤1.5 x ULN Estimated glomerular filtration rate (eGFR)\* ≥60 mL/min/1.73 m² \*MDRD-GFR (mL/min/1.73 m²) = 186 × (serum creatinine)-1.154 × (age)-0.203 (× 0.742 for females) 7. Individuals with appropriate hematologic function confirmed within 2 weeks prior to screening without transfusion, based on the following criteria: Hemoglobin \>8.0 g/dL Absolute neutrophil count (ANC) \>1,000/μL Absolute lymphocyte count (ALC) ≥300/μL Platelets ≥50,000/μL 8. Individuals who are hemodynamically stable at the time of screening, have no signs of pericardial effusion, and have a left ventricular ejection fraction of 50% or higher based on an echocardiogram (ECHO) or multigated acquisition (MUGA) scan. 9. Individuals from whom adequate non-mobilized cells for Anbal-cel manufacturing can be collected through leukapheresis. 10. Individuals with an expected survival of 12 weeks or longer. 11. Individuals who agree to comply with the scheduled site visits, examination schedules, and assessments as per the protocol during the course of the clinical study, including primary and secondary follow-up visits. 12. Women of childbearing potential and men who agree to use appropriate contraception\* for at least 12 months after Anbal-cel administration until Anbal-cel is no longer detected in PCR tests. \*Hormonal contraception, intrauterine system implants, dual barrier methods (simultaneous use of a diaphragm or cervical cap with a condom and spermicide), sterilization procedures (e.g., vasectomy, bilateral tubal ligation), etc. Exclusion Criteria: 1. Individuals with a history of allogeneic hematopoietic stem cell transplantation. 2. Individuals with the following medical history: * History of other malignancies, except B-cell non-Hodgkin lymphoma, within 3 years prior to screening (however, individuals with a history of basal cell carcinoma, squamous cell carcinoma of the skin, localized prostate cancer, papillary thyroid cancer, cervical carcinoma in situ, or early-stage gastric cancer may participate if the investigator considers them to be fully cured after successful treatment, even if 3 years have not passed). * History of unstable angina and/or myocardial infarction within 12 months prior to screening. * History of thromboembolism, pulmonary embolism, or bleeding diatheses within 6 months prior to screening. * History of hypoxia, clinically significant pleural effusion, or abnormal electrocardiogram findings within 6 months prior to screening. 3. Individuals with the following conditions at the time of screening: * Known positive for human immunodeficiency virus (HIV). * Active neurological autoimmune or inflammatory diseases (e.g., Guillain-Barré syndrome, amyotrophic lateral sclerosis). * Recurrent or symptomatic ventricular tachycardia or atrial fibrillation with rapid ventricular response despite treatment in the 3 months prior to screening. 4. Individuals whose disease is rapidly progressing, as determined by the investigator. 5. Individuals who have undergone major surgery requiring general anesthesia or respiratory support within 4 weeks prior to screening (however, video-assisted thoracoscopic surgery (VATS) or open-and-closed (ONC) surgery is permissible if conducted within 2 weeks). 6. Individuals with severe infections requiring the administration of antibiotics, antifungals, or antivirals at the time of screening or with uncontrolled active infections. 7. Individuals who have received or been exposed to other investigational drugs or devices within 4 weeks prior to screening. 8. Pregnant or breastfeeding women. 9. Individuals with a hypersensitivity to the ingredients of the investigational drug.
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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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Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
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Other studies related to the condition(s) this trial covers.
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- Can a single shot build a cancer army inside the body?
- Can a smart immune cell with a kill switch beat tough lymphomas?