This is an investigator-initiated trial aimed at assessing the safety and efficacy of PIC1 injection in the treatment of relapsed/refractory B-cell Non-Hodgkin Lymphoma.
This is an open-label, single-arm study to evaluate the efficacy and safety of in vivo generated Chimeric Antigen Receptor T-cell (CAR-T) therapy in patients with relapsed/refractory B-cell Non-Hodgkin Lymphoma. Upon enrollment, subjects will receive an intravenous infusion of PIC1 injection designed for in vivo CAR-T generation. Following infusion, subjects will be hospitalized for observation and evaluated for safety and efficacy. Subjects will be followed for up to 2 years to assess long-term disease control.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Three dose groups (1.0×10\^9 TU, 2.0×10\^9 TU, 4.0×10\^9 TU) were set up, starting from the low dose group climbing to explore the safe and effective dose.
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
RECRUITINGIncidence of Adverse Events (AEs) after infusion
Types, frequency and severity of adverse events.
Time frame: 1 month
Overall Response Rate (ORR)
The proportion of patients achieving a Complete Response (CR) and Partial Response (PR) post-treatment, as assessed per the Lugano 2014 criteria.
Time frame: 3 months
Best Overall Response (BOR)
The proportion of patients achieving a Complete Response (CR) or Partial Response (PR) post-treatment.
Time frame: 3 months
Duration of Response (DOR)
The time interval from the first documentation of CR or PR to the first documentation of disease progression (PD) or death from any cause, whichever occurs first. This metric applies only to subjects who achieve a confirmed response.
Time frame: 3 months
Progression-Free Survival (PFS)
The time from the initiation of PIC1 treatment to the first occurrence of disease progression or death from any cause, whichever occurs first.
Time frame: 3 months
Overall Survival (OS)
The time from the initiation of PIC1 treatment to death from any cause.
Time frame: 3 months
The maximum concentration (Cmax)
The maximum concentration (Cmax) of CAR-T cells in peripheral blood resulting from in vivo expansion after infusion.
Time frame: 1 month
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The time to maximum concentration (Tmax)
The time to reach the maximum concentration (Cmax) of CAR-T cells in peripheral blood resulting from in vivo expansion after infusion.
Time frame: 1 month
AUC 28d
The area under the concentration-time curve of CAR-T cells in peripheral blood over the 28-day period (AUC 28d) after infusion.
Time frame: 1 month
Serum cytokine levels
Serum cytokine levels (such as IL-6, IL-10, TNF-α, IFN-γ) at various time points after infusion.
Time frame: 1 month
Peripheral blood lymphocyte subsets
Peripheral blood lymphocyte subsets (T, B, and NK cell proportions or counts) at various time points after infusion.
Time frame: 3 months