NKG2D-based CAR T-cells Immunotherapy for Patient With r/r NKG2DL+ Solid Tumors

  • STATUS
    Recruiting
  • participants needed
    3
  • sponsor
    Fudan University
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Updated on 23 November 2021
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Summary

The primary objective of this study is to evaluate the safety and clinical activity of NKG2D-based CAR-T cells infusion in the treatment of relapsed/refractory NKG2DL+ solid tumors.

Description

The preclinical study clarified that NKG2D-based CAR-T cells showed strong cytotoxicity against NKG2DL+ cell lines in vitro as well as a therapeutic effect against NKG2DL+ cell xenografts in vivo. In addition, the data also demonstrated the safety of NKG2D-based CAR-T therapy. NKG2D-based CART represent a potentially effective and safety therapeutic approach for patient with relapsed/refractory NKG2DL+ solid tumors. In this trial, the investigators researched the safety of administering NKG2D-based CAR-T which generated with CD8 hinge region and transmembrane region, 4-1BB costimulatory region and CD3 zeta region. The investigators also assessed that disease response was determined within the context of a phase I trial.

Details
Condition Hepatocellular Carcinoma, Glioblastoma, Medulloblastoma, Colon Cancer
Age 18years - 75years
Treatment NKG2D-based CAR T-cells
Clinical Study IdentifierNCT05131763
SponsorFudan University
Last Modified on23 November 2021

Eligibility

 Yes No Not Sure

Inclusion Criteria

Men or women≥18 years old
Patient with NKG2DL+ cell tumors confirmed by pathology and histology
Fail or unwilling to receive first-line treatment
Disease must be measurable according to the corresponding guidelines
Main organs function normally and meet following requirements
Routine blood index No Blood transfusion within 14 days 1)HB≥90g/ L
)ANC≥1.5×109/L; 3)PLT≥75×109/L# Serum biochemicals index 1) BIL <1.5 upper
normal limit (ULN); 2) ALT and AST<2.5×ULN; In the case of liver metastasis
ALT and AST<5×ULN; 3) Serum Cr≤1×ULN, endogenous creatinine clearance≥50ml/min
(Cockcroft-Gault formula); 4) ECOG physical condition score: 0-2
Expected survival time ≥3 months
Patient with adequate bone marrow reserve, hepatic and renal functions
No other uncontrolled diseases such as lung, kidney and liver infection before enrollment
Women of child-bearing age must undergo a negative pregnancy test (serum or urine) within 7 days prior to enrollment and voluntarily use appropriate methods of contraception during the observation period and within 8 weeks after the last dose; men should agree to contraception during the observation period and within 8 weeks of the last dose
Patients voluntarily participated in this trial and sign the informed consent form
Patients with compliance and expected to follow up the efficacy and adverse reactions as required by the protocol

Exclusion Criteria

\. Pregnant or lactating women, 2. Patients who need to use systemic steroids at the same time, 3. Under following treatment conditions currently: 1) during the other antitumor clinical observation period within 14 days before blood collection; 2) patient has not recovered from acute side effects of the previous treatment; 4. Receive radiotherapy within 4 weeks before enrollment, 5. Patients who received any other cell therapy before, 6. Patients with unqualified T cell amplification efficiency, 7. Uncontrolled symptoms or other illnesses, including but not limited to infection, congestive heart failure, unstable angina, arrhythmia, psychosis, 8. Patients with severe acute allergic reactions, 9. Patients who have received other cell therapies, 10. Other serious conditions that may limit patient's participation in the study
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