Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors

Malignant Solid Tumour Clinical Trial

Official title:

Combination of Anti-PD-1 and NK Immunotherapy for Recurrent Solid Tumors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02843204
• Other study ID #: NK-PD-1
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: July 1, 2016
• Est. completion date: July 1, 2019

Study information

• Verified date: May 2020
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study is the safety and efficacy of anti-PD-1 plus NK immunotherapy to multiple solid tumors.

Description:

By enrolling patients with solid tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of the combined therapy using anti-PD-1 and natural killer (NK) cells.

The safety will be evaluated by statistics of adverse reactions. The efficacy will be evaluated according to local relief degree, progress free survival (PFS) and overall survival (OS).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• All standard therapies have failed according to NCCN guidelines or the patient refuses standard therapies after cancer recurrence

• Progression after chemotherapy or appropriate TKI treatment for those patients with an EGFR-sensitizing mutation or ALK rearrangement

• KPS = 70, lifespan > 3 months, PD-L1 TPS of 1% or greater

• Platelet count = 80×10^9/L,white blood cell count = 3×10^9/L, neutrophil count = 2×10^9/L, hemoglobin = 80 g/L

Exclusion Criteria:

• Patients with cardiac pacemaker

• Patients with brain metastasis

• Patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction, myelosuppression, autoimmune disease, pneumonitis

• Previous treatment with a therapeutic antibody against CTLA4, PD-L1, or PD-1, or PD-L1/PD-1 pathway-targeting agents.

Related Conditions & MeSH terms

• Malignant Solid Tumour
• Neoplasms

Intervention

Drug:
• Pembrolizumab
Patients received i.v. pembrolizumab (10 mg/kg) on day 1 of a 21-day cycle, until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure

Biological:
• NK immunotherapy
Each treatment: about 10 billion cells in all, infusion in 3 times, i.v.

Locations

Country	Name	City	State
China	Cancer Institute in Fuda Cancer Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou	Shenzhen Hank Bioengineering Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PFS	PFS was defined as the interval between treatment initiation and local relapse,	2 year
Primary	OS	OS was calculated as the interval from treatment initiation to death.	3 years
Secondary	PD-1	Peripheral blood (6 mL) was obtained from healthy donors and patients before treatment and 90 days after treatment for the detection of PD-1	3 months
Secondary	Tumor size	The tumor responses of the enrolled patients were assessed by CT in accordance with RECIST v1.1.Institute Common Terminology Criteria for Adverse Events (v4.0).	3 months
Secondary	CEA	CEA was evaluated by a chemiluminescent immunoassay before treatment and 90 days after treatment.	3 months
Secondary	CTC	The absolute number of CD45-CK+ CD326+ cells was used to quantitate the CTC levels.	3 months