Nanobody-Powered CAR-Ts take on tough lymphoma
NCT ID NCT07546630
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests a new type of CAR-T cell therapy that uses tiny antibodies (nanobodies) to target two markers on cancer cells (CD19 and CD20). The goal is to see if it is safe and to find the best dose for people with B-cell lymphoma that has come back or not responded to other treatments. About 20 participants will receive the therapy and be monitored for side effects and tumor response.
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
-
Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
-
About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
-
Apr 2026
An estimate. Start dates often move.
- Expected to finish
-
May 2029
An estimate. End dates often move.
- Lead sponsor
-
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
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
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. The subject has voluntarily signed the informed consent form with full consent, and is willing and able to comply with the scheduled visits, study treatments, laboratory tests, and other trial procedures 2. Patients with relapsed/refractory B-cell lymphoma confirmed by cytology or histology according to the WHO 2022 Classification: * Lymphoma cells confirmed to express CD19 and/or CD20 antigen by immunophenotyping or histopathological immunohistochemistry * B-cell lymphomas include: aggressive B-cell lymphomas (LBCL, BL, MCL) and indolent B-cell lymphomas (CLL/SLL, FL, MZL, LPL, HCL) * Relapsed/refractory B-cell lymphoma: For patients with aggressive lymphoma, disease stable for ≤12 months or disease progression after achieving best response following at least first- and second-line pharmacotherapy; or disease progression or relapse within ≤12 months after autologous stem cell transplantation. For patients with indolent lymphoma, disease progression, relapse or transformation following at least three lines of prior therapy 3. Aged 18-75 years (inclusive), male or female 4. Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 5. Estimated overall survival of more than 3 months from the date of signing the informed consent form 6. Hemoglobin (HGB) ≥ 70 g/L (transfusion permitted) 7. Adequate hepatic, renal and cardiopulmonary function meeting the following criteria: * Creatinine ≤ 1.5 × ULN; * Left ventricular ejection fraction (LVEF) ≥ 50%; * Blood oxygen saturation \> 90%; * Total bilirubin ≤ 1.5 × ULN; ALT and AST ≤ 2.5 × ULN 8. The subject agrees to use contraceptive measures from the date of signing the informed consent form until 1 year after CAR-T cell infusion Exclusion Criteria: * Severe cardiac insufficiency with left ventricular ejection fraction \< 50% * History of severe pulmonary function-impairing diseases * Concomitant other advanced malignant neoplasms * Concomitant severe infection that cannot be effectively controlled * Concomitant severe autoimmune diseases or congenital immunodeficiency disorders * Active hepatitis (hepatitis B virus deoxyribonucleic acid \[HBV-DNA\] or hepatitis C virus ribonucleic acid \[HCV-RNA\] test result above the lower limit of detection) * Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection * History of severe allergy to biological products (including antibiotics) * Patients with allogeneic hematopoietic stem cell transplantation who still have acute graft-versus-host disease (GVHD) after one month of discontinuation of immunosuppressive agents
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Relapsed/refractory B-cell lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Could an AI-Designed pill take on Hard-to-Treat cancers?
- Engineered immune cells take aim at tough childhood cancers
- Experimental 'Off-the-Shelf' CAR-T therapy takes on tough lymphoma
- Promising CAR-T trial for blood cancer withdrawn before starting
- New hope for tough lymphomas: experimental drug STP938 enters human trials
- New CAR-T therapy takes aim at tough lymphoma cancers