Clinical Study of Novel TLR2-Containing CAR-T Cells Targeting CD19 and CD22 for Relapsed/Refractory B-ALL and NHL

Launched by TONGJI HOSPITAL · Mar 11, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new type of treatment called CAR-T cell therapy, specifically using CAR1922T2 T-cells, for patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) and non-Hodgkin's lymphoma (NHL). The goal is to see how safe and effective this therapy is. Participants in the study will receive a single infusion of these specially modified T-cells and will be monitored closely for three years to track their health and response to the treatment.

To be eligible for this trial, participants must be between 18 and 80 years old and have been diagnosed with either B-ALL or NHL that has not responded to previous treatments. They also need to have certain tests confirming specific markers in their blood, which are important for the therapy to work. Additionally, participants must have good overall health and functioning of major organs. While the trial is not currently recruiting, it's important to know that if you or a loved one are considering participating in similar studies, understanding the criteria and expected commitments, like follow-ups and possible side effects, is crucial for making an informed decision.

Gender

ALL

Eligibility criteria

• 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.