New CAR t therapy targets two proteins to fight blood cancers
NCT ID NCT07166549
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial tests a new type of CAR T cell therapy that targets two proteins (CD19 and CD20) on B cell cancer cells. It is for adults with B cell leukemia or lymphoma who have run out of standard options, including commercial CAR T cells. The main goal is to check safety, but researchers will also look at how well the treatment shrinks tumors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- bispecific anti-CD19, anti-CD20 CAR T cells
- What this could lead to
- If this works, it could offer a new treatment option for people with B cell cancers that have not responded to other therapies, including commercial CAR T cells.
- What could go wrong
- This is a very early phase 1 trial with only 12 participants, so it is too soon to know if it is safe or effective. There are known risks like cytokine release syndrome and neurological side effects.
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 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Nov 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 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: * Age ≥ 18 years * Diagnosis of B-cell NHL or B-ALL with relapsed, refractory disease and no available standard therapeutic options (including commercially accessible CAR T products), including: * Acute B-lymphoblastic leukaemia * Burkitt lymphoma * Primary CNS lymphoma * DLBCL or high-grade lymphoma of any subtype * Primary mediastinal B cell lymphoma (including grey zone lymphoma) * Mantle Cell lymphoma * Low-grade B-cell NHLs: Follicular lymphoma, chronic lymphocytic leukaemia (CLL)/ small lymphocytic lymphoma (SLL), marginal zone lymphoma, hairy cell leukaemia, splenic B-cell lymphoma/leukaemia with prominent nucleoli, and lymphoplasmacytic lymphoma * CD19 and/or CD20 positive disease on most recent evaluation (by immunohistochemistry or flow cytometry) * ECOG clinical performance status ≤2 * Able to provide written informed consent. * Adequate organ function and bone marrow reserve, unless clearly caused by lymphoma and considered reversible, defined as: * Adequate hepatic function: Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) ≤3.0 × (ULN) and serum bilirubin ≤2.0 × ULN (except in congenital hyperbilirubinemia, such as Gilbert syndrome, where direct bilirubin ≤3.0 × ULN is allowed) * Adequate renal function: creatinine clearance ≥30 mL/min/1.73 m2 * Adequate pulmonary function: Forced Expiratory Volume in 1 second (FEV1) ≥50% (with adequate compliance) and pulse oxygenation \> 91% with room air. * Adequate cardiac function: Left Ventricular Ejection Fraction (LVEF) ≥ 40%, and no clinically significant arrhythmia * Adequate bone marrow reserve (Hemoglobin ≥80 g/L (with or without recombinant erythropoietin or red blood cell transfusions), Platelets ≥ 50×10\^9/L (with or without platelet transfusions), Absolute Neutrophil Count (ANC) 1.0 ×10\^9/L (prior growth factor support is permitted but must be without support in the 7 days before the laboratory test), Absolute Lymphocyte Count ≥0.3 ×10\^9/L) * Willingness to practice highly effective methods of birth control, and, in females of childbearing potential, negative urine or serum pregnancy test before study inclusion, lymphapheresis, and lymphodepleting chemotherapy. Exclusion Criteria: * Requirement for systemic corticosteroids, i.e. ≥20 mg of prednisone or equivalent daily. Other immunosuppressive drugs * Any organ failure, respectively not meeting the inclusion criteria of adequate organ function, or active, BKuncontrolled autoimmune disease. * Uncontrolled coronary artery disease or uncontrolled arrhythmias * Stroke within the previous 6 months, a history of neurodegenerative disorder or overt clinical evidence of dementia or altered mental status. * Seizure within 6 months of signing the ICF unless related to the primary disease (e.g. CNS lymphoma). * Active secondary malignancy that progressed or required treatment in the last 24 months, other than basal or squamous cell carcinomas of the skin. Further allowed exceptions are: Non-muscle-invasive bladder cancer, non-invasive cervical cancer, or other malignancy that is considered cured or to have a minimal risk of recurrence (e.g. a history of localized prostate or localized and treated breast cancer). * Uncontrolled active bacterial, fungal, or viral infections, particularly active hepatitis B, hepatitis C, or HIV infection. * Contraindications, known life-threatening allergies, hypersensitivity, or intolerance to any of the study treatments, including previous severe reactions to dimethyl-sulfoxide * Cytotoxic chemotherapy within 14 days before apheresis collection for CAR-T cells, respectively 12 weeks for Bendamustin and Fludarabine, and 6 months for Alemtuzumab and ATG. * Cytotoxic chemotherapy (except for lymphodepletion) within 14 days of CAR-T cell infusion. * Patients who have undergone allogeneic hematopoietic stem cell transplantation less than 12 weeks ago, have evidence of active graft-versus-host-disease (GVHD) of any grade, or are currently on immunosuppression. * Previous CAR-T cell therapy within 12 weeks of planned CAR-T cell infusion. * Investigational treatments within other trials ≤ 4 weeks before enrollment. * Lack of safe contraception; Women who are pregnant or breastfeeding; and men who plan to father a child while enrolled in this study within 1 year of receiving bispecific anti-CD20, anti-CD19 CAR T cells.
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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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University Hospital Basel, Division of Hematology or Medical Oncology
Basel, Canton of Basel-City, 4031, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can antibody infusions outperform antibiotics in shielding CAR-T patients from infections?
- Engineered immune cells take aim at tough childhood leukemia
- Double-Targeted immune cells take aim at Hard-to-Treat blood cancers
- Double-Pronged immune cells take aim at blood cancers