RecruitingNot ApplicableNCT06478225

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

Clinical Study on the Safety and Preliminary Efficacy of BGT007H Cell Therapy in Patients With Recurrent/Refractory Pancreatic Cancer


Sponsor

RenJi Hospital

Enrollment

12 participants

Start Date

May 7, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests BGT007H, an experimental CAR-T cell therapy (where a patient's own immune cells are engineered to attack cancer), in patients with pancreatic cancer that has returned or stopped responding to standard treatments. **You may be eligible if...** - You are between 18 and 75 years old - You have confirmed advanced pancreatic cancer that has progressed after at least two prior treatments - Your expected survival is at least 3 months - Your overall health and organ function are adequate (ECOG 0 or 1) **You may NOT be eligible if...** - You have never received prior chemotherapy for pancreatic cancer - You have severe organ impairment - You have active infections or autoimmune conditions - Your cancer has invaded major blood vessels in ways that make treatment unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBGT007H 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).


Locations(1)

Renji hospital

Shanghai, Shanghai Municipality, China

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NCT06478225


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