Status:
NOT_YET_RECRUITING
Clinical Study of Novel TLR2-Containing CAR-T Cells Targeting CD19 and CD22 for Relapsed/Refractory B-ALL and NHL
Lead Sponsor:
Tongji Hospital
Conditions:
R/R NHL
Eligibility:
All Genders
18-80 years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this clinical trial is to evaluate the safety and efficacy of CAR1922T2 T-cell therapy in participants with relapsed/refractory B-cell acute lymphoblastic leukemia and non-Hodgkin's lym...
Detailed Description
Acute lymphoblastic leukemia (ALL) is a hematological malignancy characterized by the clonal proliferation of precursor lymphoid cells, with a cure rate of only 30-40% in adults through standardized c...
Eligibility Criteria
Inclusion
- 1\. The patient or their legal guardian voluntarily participates and signs an informed consent form.
- 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.
- 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.
- Good major organ function:
- Liver function: ALT/AST \< 3 times the upper limit of normal (ULN) and total bilirubin ≤ 34.2 μmol/L;
- Kidney function: Creatinine clearance rate (Cockcroft-Gault method) ≥ 60 mL/min;
- Lung function: Oxygen saturation ≥ 95%, with no active pulmonary infection;
- Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%; no significant pericardial effusion, no clinically significant ECG abnormalities.
- 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.
- ECOG score ≤ 1. 9.Life expectancy greater than 3 months.
Exclusion
- Women who are breastfeeding. 2.Patients with uncontrollable infectious diseases within 4 weeks before enrollment.
- 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.
- Patients who have participated in other clinical trials within 4 weeks before enrollment.
- 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.
- Patients with mental illness. 10.Patients with drug abuse/addiction. 11.Use of contraindicated medications.
- . 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.
- . Chemotherapy: Received salvage chemotherapy within 2 weeks before leukocyte collection.
- . Allogeneic cell therapy: Received donor lymphocyte infusion within 4 weeks before leukocyte collection.
- . GVHD treatment: Received anti-GVHD treatment within 4 weeks before CAR-T cell infusion targeting CD19 and CD22.
- . Use of alemtuzumab, or cladribine within 6 months before leukocyte collection, or use of chlorambucil or clofarabine within 3 months.
Key Trial Info
Start Date :
February 15 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2029
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06879262
Start Date
February 15 2026
End Date
February 28 2029
Last Update
January 6 2026
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.