Status:
UNKNOWN
Allogeneic γδ T Cell Therapy for the Treatment of Solid Tumors
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Malignant Solid Tumours
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The study is to determine the safety, feasibility and efficacy of allogeneic γδ T cell therapy in patients with solid tumors.
Detailed Description
This is an open-label, single-center, phase 1/2 study to evaluate the safety, feasibility and efficacy of allogeneic γδ T cell therapy. In phase 1 period, a typical 3+3 dose-escalation design will be ...
Eligibility Criteria
Inclusion
- Histological confirmation of malignant solid tumors, including patients received surgery, patients with initially diagnosed or pre-treated local advanced/metastatic malignancies, and patients with B-cell non-Hodgkin's lymphomas.
- Patients should sign informed consent form voluntarily before the trail and comply with the requirements of this study.
- Age from 18 to 75 years old, gender unlimited.
- Eastern Cooperative Oncology Group (ECOG) Performance score≤2.
- Patient with adequate bone marrow reserve (Haemoglobin≥80g/L, Absolute Neutrophil Count (ANC) ≥1×10\^6/L, Platelet≥75×10\^9/L or ≥50×10\^9/L for liver tumors), hepatic function (Aspartate Aminotransferase (AST) / Alanine Aminotransferase (ALT) ≤ 3.0x upper limit of normal or ≤ 5 x ULN for liver tumors or liver metastases, Total bilirubin ≤ 1.5 x ULN), renal function (Creatinine ≤ 1.5 x upper limit of normal (ULN)) and cardiac function (Left ventricular ejection fraction of ≥50% by ECHO).
- Patient with life expectancy of at least 3 months.
- Patient without bleeding and coagulation disorders.
- Patient without obvious genetic diseases.
- Toxicity from previous antitumor therapy ≤ grade 1 (according to CTCAE version 5.0) or to an acceptable level of inclusion/exclusion criteria (other toxicities such as alopecia and vitiligo considered by the investigator to pose no safety risk to the subject).
- Male and female patients of reproductive potential must agree to use birth control during the study and for at least 12 weeks post study.
Exclusion
- Patients who received or are to receive any other cell therapy within 4 weeks before the planned day for the first allogeneic γδ T cell administration.
- Patients who participated or are to participate in other interventional clinical trial within 30 days before the planned day for the first allogeneic γδ T cell administration.
- Uncontrolled serious active infection (such as sepsis, bacteremia and fungemia, HBV, HCV, HIV, TP, CMV or EBV infection).
- Systemic steroid therapy or other immune-suppressants (except in cases where the patient is receiving treatment with replacement doses for adrenal insufficiency).
- Pregnancy or lactation before or during the trial.
- Patients with history of prior organ or bone marrow transplantation.
- Patients with systemic vasculitis, or with active or uncontrolled autoimmune diseases, as well as primary or secondary immunodeficiency diseases.
- History of epilepsy or other active central nervous system disorders.
- Patients inoculated live vaccine within 6 weeks before screening.
- Allergic constitution, history of allergies to blood products, known to be allergic to any substances in the protocol(such as Zoledronate or similar).
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or any other medical condition that precludes surgery. Also, psychiatric illness/social situations that would limit compliance with study requirements.
- Any other situations that investigators believe the risk of the subjects is increased or results of the trial are disturbed
- Donor Inclusion Criteria:
- Sign informed consent form.
- Age 18 years up to the age of 50 (≤50), gender unlimited.
- Relative to patients (unrestricted to blood relationship).
- Apheresis available.
- PLT≥100×109/L with normal APTT or PT.
- preculture of γδ T cells meets the requirements of massive amplification and detection.
- Donor
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04765462
Start Date
March 1 2021
End Date
December 31 2024
Last Update
October 4 2022
Active Locations (1)
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1
Biotherapeutic Department of Chinsese PLA Gereral Hospital
Beijing, Beijing Municipality, China, 100853