Status:
WITHDRAWN
NKG2D-based CAR T-cells Immunotherapy for Patient With r/r NKG2DL+ Solid Tumors
Lead Sponsor:
Jiujiang University Affiliated Hospital
Collaborating Sponsors:
KAEDI
Conditions:
Hepatocellular Carcinoma
Glioblastoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief 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.
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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; 2)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,
- Patients who need to use systemic steroids at the same time,
- Under following treatment conditions currently: 1) during the other anti- tumor clinical observation period within 14 days before blood collection; 2) patient has not recovered from acute side effects of the previous treatment;
- Receive radiotherapy within 4 weeks before enrollment,
- Patients who received any other cell therapy before,
- Patients with unqualified T cell amplification efficiency,
- Uncontrolled symptoms or other illnesses, including but not limited to infection, congestive heart failure, unstable angina, arrhythmia, psychosis,
- Patients with severe acute allergic reactions,
- Patients who have received other cell therapies,
- Other serious conditions that may limit patient's participation in the study.
- Detailed disease specific criteria exist and can be discussed with contacts listed below.
Exclusion
Key Trial Info
Start Date :
March 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2020
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04270461
Start Date
March 17 2020
End Date
October 17 2020
Last Update
October 22 2020
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Affiliated hospital of jiujiang university
Jiujiang, Jiangxi, China, 332000