New CAR-T therapy targets lymphoma that escapes standard treatment
NCT ID NCT07369492
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests a new type of CAR-T cell therapy called BAFF-R CAR-T for adults with a specific kind of B-cell lymphoma that has stopped responding to treatment and does not have the CD19 marker. The study will enroll 30 people to see if the treatment is safe and tolerable. Participants receive a single infusion of their own modified immune cells designed to find and attack the cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BAFF-R CAR-T cells
- What this could lead to
- If this works, it could offer a new treatment option for people with B-cell lymphoma that does not respond to standard therapies and has stopped responding to CD19-targeted treatments.
- What could go wrong
- This is a very early Phase 1 trial with only 30 participants, so it is too soon to know if it is safe or effective. CAR-T cell therapy can cause serious side effects like cytokine release syndrome and nervous system 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 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Jan 2029
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 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\. Subjects voluntarily participate in clinical research and sign informed consent. * 2\. Subjects with CD19-negative relapsed or refractory B-cell lymphoma: a) failure to achieve CR after 6 cycles, or PR after 3 cycles, of first-line therapy, or achieve CR after first-line therapy but relapse within 12 months; b) achieve CR after systemic treatment, but are refractory or relapsed, and no plan to transplant, or prepare for transplantation but cannot meet transplantation criteria after second-line therapy; c) not achieve CR after at least two courses of second-line treatment (including autologous stem cell transplantation). * 3\. Expected survival ≥ 3 months. * 4\. BAFF-R expression are detected on tumor cells of subjects by flow cytometry or immunohistochemistry. * 5\. ECOG score ≤ 2. * 6\. Subjects with adequate organ functions prior to enrollment, meet the following laboratory values: * Renal function: serum creatinine ≤ 1.5 × ULN or estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73 m² * Hepatic function: Serum alanine aminotransferase (ALT) ≤ 5 × age-specific ULN and total bilirubin ≤ 2.0 mg/dL, except in subjects with Gilbert-Meulengracht syndrome. If total bilirubin ≤ 3.0 × ULN and direct bilirubin ≤ 1.5 × ULN, subjects with Gilbert-Meulengracht syndrome are included. * Pulmonary reserve: ≤ Grade 1 dyspnea and oxygen saturation \>95% on room air. * 7\. Stable hemodynamics and left ventricular ejection fraction (LVEF) ≥ 45 % assessed by echocardiography or multi-gated radionuclide angiography (MUGA). * 8\. Adequate bone-marrow reserve without blood transfusion as defined by: * Absolute neutrophil count (ANC) ≥ 1 x 10\^9/L. * Absolute lymphocyte count (ALC) ≥ 0.1 x 10\^9/L. * Platelets ≥ 50 x 10\^9/L. * Hemoglobin \>80g/L. * 9\. In the investigator's judgment, subjects' general condition and all biochemical values are either normal or sufficiently compensated to receive lymphodepletion and CAR-T cell therapy. Exclusion Criteria: * 1\. Women who are pregnant or breastfeeding, or planned pregnancy within 6 months. * 2\. Infectious disease(HIV, Active Tuberculosis ect.). * 3\. Active infection: hepatitis B, hepatitis C. * 4\. Abnormal vital signs or refuse to receive examination. * 5\. Subjects with psychiatric or psychological disorders are unable to complete treatment or efficacy assessment. * 6\. History of severe hypersensitivity or known hypersensitivity to IL-2. * 7\. Systemic or local severe infection requiring antimicrobial therapy. * 8\. Significant dysfunction of vital organs (heart, lung, brain, kidney, etc.), or in the investigator's judgment, subjects are unable to be enrolled with any other condition.
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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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Suzhou Hongci Hematology Hospital
RECRUITINGSuzhou, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Boosting CAR t cells: could a pill make lymphoma therapy more effective?
- Military study probes Toxins' role in lymphoma