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Evaluate the Safety and Efficacy of BGT007H Cell Therapy in Patients With Relapsed/Refractory Pancreatic Cancer

NCT06478225 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-06-27

No results posted yet for this study

Summary

The primary objective of this study is to evaluate the safety and tolerability of BGT007H cell therapy in patients with recurrent/refractory pancreatic cancer.

Conditions

  • Tumor Pancreas

Interventions

DRUG

BGT007H Cell Injection

Intervention roughly goes through 3 phases (the day of cell infusion is defined as day 0, d0): 1. Apheresis and baseline period: Eligible subjects are enrolled for leukapheresis to prepare BGT007H cell injection solution, and baseline assessment is performed from after apheresis to before preconditioning. 2. Preconditioning (d-5\~d-3): Patients begin preconditioning (FC regimen) 5 days before BGT007H cell administration. A 2-day rest and observation period is conducted after preconditioning. The FC regimen is as follows: * Fludarabine: 25\~30mg/m2/d, intravenous infusion, once a day, for 3 consecutive days; * Cyclophosphamide: 250\~350mg/m2/d, intravenous infusion, once a day, for 3 consecutive days. 3. Cell infusion (d0) and DLT observation period (d0\~d28).

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Liwei Wang, Doctorate · RenJi Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-05-07
Primary Completion
2027-03-31
Completion
2027-08-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06478225 on ClinicalTrials.gov