Allogeneic γδ T Cell Therapy for the Treatment of Solid Tumors

NCT04765462 | Unknown Phase 1

• 1 other identifier: CHN-PLAGH-BT-061
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The study is to determine the safety, feasibility and efficacy of allogeneic γδ T cell therapy in patients with solid tumors.

Conditions

Malignant Solid Tumours

Outcome Measures

Primary Outcomes (2)

• Incidence of dose-limiting toxicity (DLT)

  The dose escalation strategy will follow the Food and Drug Administration Guideline for design of early phase clinical trials of cellular therapy products.

  Baseline to Day 30

• Incidence of severe adverse events

  Safety of the γδ T cell infusion will be based on the risk of treatment-related severe adverse events as identified in the National Cancer Common Terminology Criteria for Adverse Events (CTCAE) version 5.

  Baseline to Day 100

Secondary Outcomes (5)

• Objective Response Rate

  Baseline to 2years

• Duration of Response

  Baseline to 2years

• Overall Survival

  Baseline to 2years

• Progress Free Survival

  Baseline to 2years

• Intervention Treatment-related adverse events(AEs)

  Baseline to 12 months

Other Outcomes (1)

• Exploratory research

  Baseline to 12 months

Study Arms (1)

Allogeneic γδ T cell Group

EXPERIMENTAL

Enrolled patients will be administered allogeneic γδ T cells with or without the combinations of traditional therapies, including chemotherapy, targeted therapy, radiotherapy, immune checkpoint inhibitors and others.

Biological: Allogeneic γδ T cells

Interventions

Allogeneic γδ T cells BIOLOGICAL

Phase 1:Enrolled patents will be administered allogeneic γδ T cells from 2x10\^6/kg, 1 x10\^7/kg to 5x10\^7/kg every 2-4 weeks to determine the recommended dose level. Phase 2: Enrolled patents will be administered allogeneic γδ T cells at the recommended dose level to confirm the efficacy. Whether or not in combination with other therapies will be determined by research physicians according to the disease status of enrolled patients.

Allogeneic γδ T cell Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Male and female patients of reproductive potential must agree to use birth control during the study and for at least 12 weeks post study.
• 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
• Sign informed consent form.
• Age 18 years up to the age of 50 (≤50), gender unlimited.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Biotherapeutic Department of Chinsese PLA Gereral Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Study Officials

• Weidong Han, M.D

  Biotherapeutic Department of Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Yanshan Li

  Biotherapeutic Department of Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

• Kaichao Feng

  Biotherapeutic Department of Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Weidong Han, M.D

CONTACT

+8601066937463; hanwdrsw69@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 17, 2021
• First Posted: February 21, 2021
• Study Start: March 1, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: October 4, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)