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

ConditionTumor Pancreas
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRenJi Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

voluntarily sign an informed consent form in writing.

Age ≥18 years and ≤75 years, both male and female are eligible.

Expected survival ≥ 3 months.

Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1.

Disqualifiers

Has active central nervous system (CNS) metastasis (except for those treated and stable).

HIV positive, HBsAg positive with positive Hepatitis B virus (HBV) DNA copy number (greater than the lower limit of detection), Hepatitis C virus (HCV) antibody positive and HCV RNA positive, syphilis non-treponemal antibody (RPR or TRUST) positive.

Has a mental or psychological disorder that cannot cooperate with treatment and efficacy evaluation.

Subjects with severe autoimmune diseases who have been long-term users of immunosuppressants.

Trial design

Design model

Single group

Treatments tested in this trial

  • BGT007H Cell Injection

    Drug

    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).

Treatment groups

12 Participants
are divided into 1 treatment group
Group A: BGT007H Cell InjectionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-Limiting Toxicity (DLT)

Dose-Limiting Toxicity

Time frame
through study completion, an average of 3 year
2

Maximum Tolerated Dose (MTD)

Maximum Tolerated Dose

Time frame
through study completion, an average of 3 year
3

Optimal Biological Dose (OBD)

Optimal Biological Dose

Time frame
through study completion, an average of 3 year
4

Adverse events (AE)

Adverse events

Time frame
through study completion, an average of 3 year

Secondary outcomes

1

Evaluate the disease control rate (DCR)

Evaluate the disease control rate ,according to the RECIST 1.1 criteria.

Time frame
through study completion, an average of 3 year
2

Evaluate the duration of response (DOR)

Evaluate the duration of response ,according to the RECIST 1.1 criteria.

Time frame
through study completion, an average of 3 year
3

Evaluate the progression-free survival (PFS)

Evaluate the progression-free survival, according to the RECIST 1.1 criteria.

Time frame
through study completion, an average of 3 year

Other outcomes

1

Evaluate the overall survival (OS)

Evaluate the overall survival ,according to the RECIST 1.1 criteria.

Time frame
through study completion, an average of 3 year

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

RenJi Hospital

Lead sponsor

Source ClinicalTrials.gov
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