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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06054984
Other study ID # (2021) IEC No.288
Secondary ID
Status Recruiting
Phase Early Phase 1
First received
Last updated
Start date September 7, 2021
Est. completion date September 7, 2024

Study information

Verified date March 2023
Source Ruijin Hospital
Contact ChenLeiWen
Phone 13761638756
Email wcl12161@rjh.com.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To investigate the safety, tolerability, efficacy and pharmacokinetics of TCR-T cells in the treatment of advanced pancreatic cancer


Description:

The aim of this clinical trial is to investigate the safety, tolerability, efficacy and pharmacokinetics of TCR-T cell therapy in patients with advanced pancreatic cancer by intravenous injection, in order to explore an effective cellular immunotherapy method for the treatment of advanced pancreatic cancer


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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TCR-T Cells Injection(GB3010 Cells Injection)
The TCRT cells used in this clinical trial were derived from the patient's autologous peripheral-blood T cells and were genetically transduced to express a T-cell Receptor that recognizes the RAS/TP53.Patients were sequentially enrolled into 3 dose escalation groups(dose level 1-3) :5×10^8±20%,5×10^9±20%,5×10^10±20%.

Locations

Country Name City State
China Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine ShangHai Shanghai

Sponsors (2)

Lead Sponsor Collaborator
Ruijin Hospital Shanghai Essight Bio Co.,Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other To explore the correlation between the proliferation and persistence of TCRT cells in body and the efficacy observe correlation of the PK parameters with response (CR, PR, relapse),PK parameters including peak (Cmax) of neoantigen-specific TCRT cells in blood and tumor tissue, time to peak (number of days to peakTCRT cells after infusion), Tmax) and AUC0-28 (area under the curve plotted against visit time by the number of neoantigen-specific TCRT cells in peripheral blood from day 0 to 28). 2years
Primary Evaluate the Incidence of Treatment Related Adverse Events of TCRT cells in patients with advanced pancreatic cancer collect adverse events (AE), serious adverse events (SAE), adverse events of special interest (AESI), and laboratory abnormalities (type, frequency, and severity) 2years
Primary Characterize the Peak of Peripheral Blood Concentration and Area under the Peripheral Blood concentration versus time curve of TCRT cells and observe their proliferation and persistence in body After infusion of neoantigen-specific TCRT cells, collect peak (Cmax) of neoantigen-specific TCRT cells in blood and tumor tissue, time to peak (number of days to peakTCRT cells after infusion), Tmax) and AUC0-28 (area under the curve plotted against visit time by the number of neoantigen-specific TCRT cells in peripheral blood from day 0 to 28). "If possible, AUC0-inf, terminal phase elimination rate constant (?z), elimination half-life (t1/2) will be evaluated." 2years
Secondary Correlation of the pharmacokinetic profile of TCRT cells with the Incidence of CRS and ICANS events collect changes in mutant cell concentration in peripheral blood and tumor tissue after TCRT cell reinfusion,observe correlation of these measures with CRS and ICANS events 2years
Secondary Evaluate tumor size (mm) , tumor biomarker CA19-9 (U/ml), ORR/DCR/PFS and OS of patients with advanced pancreatic cancer ORR at 2, 4, and 6 months after TCRT cell infusion (ORR=CR+PR). The primary efficacy outcome was the change in target tumor size (local control rate of target lesions). Secondary efficacy indicators: changes in tumor markers; Objective response rate (ORR), disease control rate (DCR), progression-free survival (PFS) and overall survival (OS) according to RECIST1.1 criteria 2years
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