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

NCT05131763 | Unknown Phase 1

• 1 other identifier: Fudan-Changchun
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Glioblastoma; Medulloblastoma; Colon Cancer

Keywords

NKG2D-based CAR T-cells; solid tumors

Outcome Measures

Primary Outcomes (2)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

  The number of patiens who suffered ≥ 3 grade toxicities according to the CTCAE criteria after CAR-T therapy.

  through study completion, an average of 3 months.

• Detailed adverse events post NKG2D-based CAR-T therapy.

  The events included infusion reactions, CRS, tumor lysis syndrome and hematological toxicity. The criteria mainly reffered to guidelines for immune related adverse reactions.

  through study completion, an average of 3 months.

Secondary Outcomes (3)

• overall survival (OS)

  2 years post infusion

• Progress Free Survival (PFS)

  2 years post infusion

• Partial response rate

  through study completion, an average of 3 months.

Study Arms (1)

KD-025

EXPERIMENTAL

NKG2D-based CAR T-cells Injection; Dosage:1-10x10\^6/kg, 70ml/time, The CAR-T cells will be administered by i.v. or hepatic portal artery injection over 20-30 minutes Frequency: total one time

Biological: NKG2D-based CAR T-cells

Interventions

NKG2D-based CAR T-cells BIOLOGICAL

Autologous genetically modified anti-NKG2DLs CAR transduced T cells

KD-025

Eligibility Criteria

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

You may qualify if:

• 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,

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• Fudan University: lead
• KAEDI: collaborator

Study Sites (1)

Xunyang Changchun Shihua Hospital

Jiujiang, Jiangxi, 332000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Glioblastoma; Medulloblastoma; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroectodermal Tumors, Primitive; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• kuaile zhao, doctor

  Fudan University

  STUDY DIRECTOR

• Changchun Cai, doctor

  Xunyang Changchun Shihua Hospital

  STUDY DIRECTOR

Central Study Contacts

Hui Xu

CONTACT

13337719185; huixu1989@163.com

Jiaying Deng, doctor

CONTACT

18017312829; dengjiaying3@sina.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: November 23, 2021
• Study Start: March 1, 2021
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2023
• Last Updated: November 23, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)