New CAR-T therapy targets two proteins to fight tough leukemia and lymphoma
NCT ID NCT06879262
First seen Jun 26, 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 CD22) on cancer cells. It is for people with relapsed or refractory B-cell acute lymphoblastic leukemia or non-Hodgkin lymphoma. Participants receive a single infusion of these modified immune cells and are followed for three years to check safety and response.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CAR1922T2 T cells (a type of immune cell therapy that targets two proteins on cancer cells)
- What this could lead to
- If successful, this could offer a new treatment option for people with hard-to-treat B-cell cancers that have not responded to standard therapies.
- What could go wrong
- This is a very early (Phase 1) trial with only 60 participants, so safety and effectiveness are not yet proven. CAR-T therapy can cause serious side effects like cytokine release syndrome.
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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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2029
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 to 80 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: * 1\. The patient or their legal guardian voluntarily participates and signs an informed consent form. 2.Age between 18-80 years old (inclusive), with no gender restrictions. 3.Diagnosed with acute B-cell acute lymphoblastic leukemia or non-Hodgkin's lymphoma according to the WHO 2016 classification. 4.CD19 or CD22 positivity confirmed by flow cytometry or histopathology. 5.Diagnosed with refractory/relapsed B-cell acute lymphoblastic leukemia or non-Hodgkin's lymphoma. 6.Good major organ function: 1. Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤ 34.2 μmol/L; 2. Kidney function: Creatinine clearance rate (Cockcroft-Gault method) ≥ 60 mL/min; 3. Lung function: Oxygen saturation ≥ 95%, with no active pulmonary infection; 4. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; no significant pericardial effusion, no clinically significant ECG abnormalities. 7.Women of childbearing age with negative urine/blood pregnancy test during screening and agree to use contraceptive measures for at least 1 year after infusion; male subjects with reproductive capacity must agree to use effective barrier contraceptive methods for at least 1 year after infusion. 8.ECOG score ≤ 1. 9.Life expectancy greater than 3 months. Exclusion Criteria: * 1.Women who are breastfeeding. 2.Patients with uncontrollable infectious diseases within 4 weeks before enrollment. 3.Active hepatitis B/C. 4.HIV-infected patients. 5.Patients with severe autoimmune diseases or immunodeficiency diseases. 6.Patients with allergic constitution, allergic to antibodies or cytokines and other large molecule biological drugs. 7.Patients who have participated in other clinical trials within 4 weeks before enrollment. 8.History of clinically significant central nervous system diseases: such as epilepsy, paralysis, aphasia, stroke, severe brain trauma, dementia, Parkinson's disease, cerebellar diseases, organic brain syndromes. 9.Patients with mental illness. 10.Patients with drug abuse/addiction. 11.Use of contraindicated medications. 1. . Steroids: Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent \>20 mg/day) within 7 days before leukocyte collection, or within 72 hours before CAR-T cell infusion targeting CD19 and CD22. However, physiological replacement, topical, and inhaled corticosteroids are allowed. 2. . Chemotherapy: Received salvage chemotherapy within 2 weeks before leukocyte collection. 3. . Allogeneic cell therapy: Received donor lymphocyte infusion within 4 weeks before leukocyte collection. 4. . GVHD treatment: Received anti-GVHD treatment within 4 weeks before CAR-T cell infusion targeting CD19 and CD22. 5. . Use of alemtuzumab, or cladribine within 6 months before leukocyte collection, or use of chlorambucil or clofarabine within 3 months.
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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 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.
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Other studies related to the condition(s) this trial covers.
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