NCT03882840

Brief Summary

T effector cells and NK cells have mutual compensatory killing functions on various of cancer types. For those cancers that have no available targets for CAR-T cell generations, we established potent T cell-like NK cells (ITNK) with a specific conversion protocol for the T cells from the patient, to perform anti-cancer therapy, especially for those cancers that are lack of MHC-I molecule expression. We have finished pre-clinical investigations for the ITNK or CAR-ITNK cell therapy and scheduled to start a clinical phase I study.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
105mo left

Started Jan 2019

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress46%
Jan 2019Jan 2035

Study Start

First participant enrolled

January 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 20, 2019

Completed
8.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2035

Last Updated

June 26, 2024

Status Verified

June 1, 2024

Enrollment Period

9 years

First QC Date

March 18, 2019

Last Update Submit

June 22, 2024

Conditions

Anti-cancer Cell ImmunotherapyT Cell and NK Cell

Keywords

Solid Tumor, ITNK, CAR-ITNK

Outcome Measures

Primary Outcomes (1)

  • The safety and tolerance of the ITNK cell immunotherapy

    A dose limiting toxicity is defined as any toxicity that is considered to be primarily related to the ITNK cells, which is irreversible, or life threatening or hematologic or non-hematologic Grade 3-5. Incidence of treatment-emergent adverse events will be calculated as standard methods.

    2 years

Secondary Outcomes (1)

  • Percent of Patients with best response as either complete remission or partial remission.

    2 years

Study Arms (2)

ITNK cell therapy group

EXPERIMENTAL

Patient-originated and induced T-to-natural killer (ITNK) cells, will be administrated to kill tumor cells.

Biological: ITNK cell therapy

CAR-ITNK cell therapy group

EXPERIMENTAL

Patient-originated and induced T-to-natural killer (ITNK) cells with CAR-engineered, will be administrated to kill tumor cells.

Biological: ITNK cell therapy

Interventions

ITNK cell therapyBIOLOGICAL

Infusion of ITNK/CAR-ITNK cells

CAR-ITNK cell therapy groupITNK cell therapy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with advanced cancer, which express low or no MHC-I.
  • Life expectancy \>12 weeks
  • Adequate heart,lung,liver,kidney function
  • Available autologous T cells
  • Informed consent explained to, understood by and signed by patient/guardian. 6. Patient/guardian given copy of informed consent.

You may not qualify if:

  • Had accepted gene therapy before;
  • Severe virus infection such as HBV,HCV,HIV,et al
  • Known HIV positivity
  • History of liver or other organ transplantation
  • Active infectious disease related to bacteria, virus,fungi,et al
  • Other severe diseases that the investigators consider not appropriate;
  • Pregnant or lactating women
  • Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day)
  • Other conditions that the investigators consider not appropriate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, 510260, China

RECRUITING

Related Publications (2)

  • Li P, Burke S, Wang J, Chen X, Ortiz M, Lee SC, Lu D, Campos L, Goulding D, Ng BL, Dougan G, Huntly B, Gottgens B, Jenkins NA, Copeland NG, Colucci F, Liu P. Reprogramming of T cells to natural killer-like cells upon Bcl11b deletion. Science. 2010 Jul 2;329(5987):85-9. doi: 10.1126/science.1188063. Epub 2010 Jun 10.

    PMID: 20538915BACKGROUND

  • Jiang Z, Qin L, Tang Y, Liao R, Shi J, He B, Li S, Zheng D, Cui Y, Wu Q, Long Y, Yao Y, Wei Z, Hong Q, Wu Y, Mai Y, Gou S, Li X, Weinkove R, Norton S, Luo W, Feng W, Zhou H, Liu Q, Chen J, Lai L, Chen X, Pei D, Graf T, Liu X, Li Y, Liu P, Zhang Z, Li P. Human induced-T-to-natural killer cells have potent anti-tumour activities. Biomark Res. 2022 Mar 24;10(1):13. doi: 10.1186/s40364-022-00358-4.

    PMID: 35331335DERIVED

Study Officials

  • Zhenfeng Zhang, MD, PhD

    Second Affiliated Hospital of Guangzhou Medical University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenfeng Zhang, MD,PhD

CONTACT

+862034153532zhangzhf@gzhmu.edu.cn

Peng Li, PhD

CONTACT

lipeng@invivobio.com.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 18, 2019

First Posted

March 20, 2019

Study Start

January 1, 2019

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2035

Last Updated

June 26, 2024

Record last verified: 2024-06

Locations

CN(1)