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

NCT04270461 | Withdrawn Phase 1

• 1 other identifier: JiujiangUH
• Study Type: interventional
• Target: N/A
• 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 severe cytokine release syndrome(CRS) as a Measure of Safety and Tolerability.

  The severe CRS post KD-025 CAR-T cells treatment will be evaluated and the maximum tolerated dose will be determined.

  0 to 28 days post infusion

• Copies numbers of CAR

  Copies numbers of CAR in peripheral blood (PB)

  1 year post infusion

Secondary Outcomes (3)

• overall survival (OS)

  2 years post infusion

• Progress Free Survival (PFS)

  2 years post infusion

• Duration of response, (DoR)

  2 years post infusion

Study Arms (1)

Arms

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

Also known as: KD-025 CAR T-cells

Arms

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• 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,
• 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.

Sponsors & Collaborators

• Jiujiang University Affiliated Hospital: lead
• KAEDI: collaborator

Study Sites (1)

Affiliated hospital of jiujiang university

Jiujiang, Jiangxi, 332000, China

Location

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

• Changchun Cai

  Affiliated hospital of jiujiang university

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: February 10, 2020
• First Posted: February 17, 2020
• Study Start: March 17, 2020
• Primary Completion: October 17, 2020
• Study Completion: October 17, 2020
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)