CCCR-NK92 Cells Immunotherapy for Non-small Cell Lung Carcinoma

• Sponsor: Xinxiang medical university (Other)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT03656705
• Collaborator: (none)
• Enrollment: 5
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 63
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The purpose of this clinical investigation is to evaluate the safety and effects of CCCR-modified NK92(CCCR-NK92)infusions in previously treated advanced non-small cell lung carcinoma(NSCLC).

Condition or Disease	Intervention/Treatment	Phase
Non-small Cell Lung Cancer	Biological: CCCR-NK92 cells	Phase 1

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 5 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Investigation of Chimeric Costimulatory Converting Receptor(CCCR)-Modified NK92 Cells in Previously Treated Advanced Non-small Cell Lung Carcinoma
• Actual Study Start Date: Sep 29, 2018
• Anticipated Primary Completion Date: Nov 30, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CCCR-NK92 cells immunotherapy Preparation of CCCR-NK92 cells suspended in a saline and plasma solution.	Biological: CCCR-NK92 cells; CCCR-NK92 cells will be administered intravenously over 1h. The starting dose of CCCR-NK92 cells will be 1×10e7-1×10e8,twice a week. The first evaluation of the efficacy after 3 weeks of treatment.

Outcome Measures

Primary Outcome Measures

1. Number of participants with adverse events evaluated with CTCAE,version 4.0 [3 months]

   Safety evaluation

2. Objective Response Rate [up to one year]

   Non-small cell lung carcinoma to CCCR-NK92 cell infusions

Secondary Outcome Measures

1. Disease Control Rate [up to one year]

2. Progression-free Survival [up to one year]

3. Overall Survival [up to one year]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 1.Male and female subjects with non-small cell lung carcinoma in patients with no available curative treatment options who have limited prognosis(≧3 months)with currently available therapies will be enrolled.

• 2.The last cytotoxic drug, radiotherapy or surgery≧4 weeks.

• 3.HB≧90g/L, ANC≧1.5×10e9/L, PLT≧80×10e9/L, TBIL≦1.5×upper limit of nomal, ALT/AST≦2.5×upper limit of nomal, ALT/AST≦5×upper limit of nomal if have liver metastasis, Cr≦1.5×upper limit of nomal or CCr≧60ml/min.

Exclusion Criteria:

• 1.Pregnancy or breastfeeding.

• 2.Known HIV, HBV or HCV infection.

• 3.Active antoimmune disease.

• 4.History of severe immediate hypersensitivity to any of the biological products including penicillin.

• 5.Severe psychiatric disorder which might interfere with the study treatment or examination.

• 6.Chronic heart failure NYHA≧III.

• 7.Simultaneous participation in another clinical trial within 4 weeks.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The first Affiliated Hospital of Xinxiang Medical University	Xinxiang	Henan	China	453000

Sponsors and Collaborators

• Xinxiang medical university

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xinxiang medical university
• ClinicalTrials.gov Identifier: NCT03656705
• Other Study ID Numbers: XinxiangMU
• First Posted: Sep 4, 2018
• Last Update Posted: Feb 14, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Study Results

No Results Posted as of Feb 14, 2022