NKG2D CAR-T(KD-025) in the Treatment of Relapsed or Refractory NKG2DL+ Tumors

Last updated: September 20, 2020
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Overall Status: Active - Not Recruiting

Phase

1

Condition

Neuroblastoma

Brain Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT04550663
2020-172-01
  • Ages > 18
  • All Genders

Study Summary

This is a Phase 1, single-arm, single-center, open-label study to evaluate the safety and effectiveness of NKG2D-based CAR-T cells infusion in the treatment of relapsed/refractory NKG2DL+ solid tumors.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18, male & female;

  2. Patients with recurrent/refractory NKG2DL+ tumors diagnosis by pathological histologyor cytology, focus on the inclusion of patients with hepatocellular carcinomapositive. (If recruit liver cancer patients, patients should with locally advanced ormetastatic hepatocellular carcinoma (HCC), Barcelona clinic liver cancer (BCLC)staging system classification for B or C, for B, patients are not suitable for localtreatment and/or surgery, or disease progression occurs after surgery and/or localtreatment, or declined to surgery and/or local treatment);

  3. Patients who fail first-line treatment or are unwilling to receive first-linetreatment;

  4. Disease progression occurred within 14 days before inclusion (RECIST criteria must beused as a basis for assessment of disease progression). According to RECIST V1.1,patients have at least one measurable lesion. Target lesions located within the fieldof previous therapeutic irradiation or within the area of local treatment (interventional or ablative treatment) are considered measurable if progress isconfirmed;

  5. The main organs function normally and meet the following requirements; Blood routine examination shall be in accordance with (no blood transfusion within 14days) :

  6. HB≥90g/L

  7. ANC ≥1.5×10^9/L

  8. PLT ≥75×10^9/L serum biochemicals examination shall be in accordance with:

  9. BIL <1.5 upper normal limit (ULN)

  10. ALT and AST<2.5×ULN; In the case of liver metastasis, ALT and AST<5×ULN

  11. Serum Cr≤1×ULN, endogenous creatinine clearance≥50ml/min(Cockcroft-Gaultformula);

  12. ECOG physical condition score: 0-1;

  13. Expected survival time ≥3 months;

  14. Cardiac function well before inclusion, no myocardial infarction attack occurredwithin half a year, and hypertension and other coronary heart disease were undercontrol at present;

  15. No other uncontrollable benign diseases such as lung, kidney, liver infection beforeenrollment;

  16. Women of childbearing age must undergo a negative pregnancy test (serum or urine)within 7 days of enrollment and voluntarily use an appropriate method of contraceptionduring observation and within 8 weeks after the last administration; men should besurgically sterilized or agree to use an appropriate method of contraception duringthe observation period and within 8 weeks after the last administration;

  17. Patients voluntarily participated in this trial and sign the informed consent form;

  18. Patients with compliance and expected to follow up the efficacy and adverse reactionsas required by the protocol;

  19. CAR-T cells amplify successfully to the expected number.

Exclusion

Exclusion Criteria:

  1. Pregnant or lactating women, pregnancy test positive by blood or urine within 48 hoursbefore immune cell transplantation;

  2. Patients who need to be treated with systemic steroid;

  3. Under following treatment conditions currently:

  4. during the other anti-tumor clinical observation period within 14 days beforeblood collection;

  5. patient has not recovered from acute side effects of the previous treatment;

  6. Receive radiotherapy within 4 weeks before enrollment;

  7. Patients who received any other cell therapy before;

  8. Transfection efficiency of lymphocytes of patients < 5% in feasibility assessmentscreening stage, or T cell amplification efficiency < 5 times;

  9. Uncontrolled symptoms or other illnesses, including but not limited to infection,congestive heart failure, unstable angina, arrhythmia, psychosis;

  10. Patients with severe acute allergic reactions, or the attending doctor believes thereis an unpredictable risk;

  11. Patients who have received other cell therapies;

  12. Other serious conditions that may limit patient's participation in the study.

Study Design

Total Participants: 10
Study Start date:
September 25, 2020
Estimated Completion Date:
March 25, 2023

Study Description

In this study,the enrollment of the patients must meet the inclusion and exclusion criteria . All subjects will be asked to continue to undergo long-term gene safety follow-up.

Connect with a study center

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

    Nanjing, Jiangsu 210000
    China

    Site Not Available

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