Aim of this study will evaluate the safety, tolerability and preliminary efficacy of chimeric antigen receptor T cells (CAR-T) targeting Igβ targets in patients with Igβ-positive refractory relapsed non-Hodgkin's lymphoma.
Non-Hodgkin's lymphoma is a group of malignant neoplasms of the lymphatic system originating from B or T cells, of which 60-70% of patients have B-cell-derived lymphoma (B-NHL). Although rituximab in combination with chemotherapy has significantly improved the prognosis of B-cell lymphoma, some patients still have primary resistance or relapse. In recent years, breakthroughs have been made in the treatment of B-cell tumors with Chimeric Antigen Receptor-Modified T Cells (CART), the investigators therefore constructed CAR-T cells targeting Igβ to investigate the safety and efficacy of CAR-T cells with this target for the treatment of r/r B-NHL.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
1. Dose escalation studies:3 dose groups in total: expect 3-6 cases in each group, and dose set at 1×106/kg,3×106/kg,6×106/kg. 2. Dose extension study:3 cases (1 dose group).
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
DLT
DLT occurring within 28 days of the last dose.
Time frame: Measured from start of treatment until 28 days after last dose
Adverse events profile
Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated.
Time frame: Measured from start of treatment until 28 days after last dose
Objective Response Rate
Proportion of CR and PR subjects will be assessed at 3 months post-infusion.
Time frame: up to 3 months
Duration of Response
Duration of overall response will be assessed from the first chimeric antigen receptor T cells (CAR-T) targeting Igβ targets given to progression, death or last follow-up.
Time frame: up to 12 months
Progression-free survival
To measure the duration of response to chimeric antigen receptor T cells (CAR-T) targeting Igβ targets over a follow-up period of 12 months.
Time frame: up to 12 months
Overall Survival
OS will be assessed from the first chimeric antigen receptor T cells (CAR-T) targeting Igβ targets given to death or last follow-up.
Time frame: up to 12 months
Peak Plasma Concentration
the peak amplification of Igβ-CART in peripheral blood.
Time frame: Measured from start of treatment until 28 days after last dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time to Peak Amplification
the time to peak amplification of Igβ-CART in peripheral blood.
Time frame: Measured from start of treatment until 28 days after last dose
AUC0-28
the area under the curve (AUC0-28) obtained by plotting the number of CAR-T cells in serum against the visit time from 0 to 28 days after reinfusion.
Time frame: Measured from start of treatment until 28 days after last dose
PD
Pharmacodynamics is the peripheral blood B-cell ratio.
Time frame: Measured from start of treatment until 28 days after last dose