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PD-1 Knockout Engineered T Cells for Metastatic Non-small Cell Lung Cancer

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ClinicalTrials.gov Identifier: NCT02793856
Recruitment Status : Completed
First Posted : June 8, 2016
Results First Posted : December 21, 2020
Last Update Posted : January 12, 2021
Sponsor:
Collaborator:
Chengdu MedGenCell, Co., Ltd.
Information provided by (Responsible Party):
You Lu, Sichuan University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Non-small Cell Lung Cancer
Interventions Drug: Cyclophosphamide
Other: PD-1 Knockout T Cells
Enrollment 12
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pre-A-One Cycle A - Two Cycles B- Two Cycles C- Two Cycles
Hide Arm/Group Description

Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.

A total of 2 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle which is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of one cycle of treatment.

Cyclophosphamide: To deplete Tregs before collecting peripheral blood

PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment

Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.

A total of 1 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.

Cyclophosphamide: To deplete Tregs before collecting peripheral blood

PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment

Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.

A total of 2 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.

Cyclophosphamide: To deplete Tregs before collecting peripheral blood

PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment

Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.

A total of 4 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.

Cyclophosphamide: To deplete Tregs before collecting peripheral blood

PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment

Period Title: Overall Study
Started 2 4 3 3
Completed 2 4 3 3
Not Completed 0 0 0 0
Arm/Group Title Pre-A-One Cycle A - Two Cycles B- Two Cycles C- Two Cycles Total
Hide Arm/Group Description

Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.

A total of 2 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of one cycle of treatment.

Cyclophosphamide: To deplete Tregs before collecting peripheral blood

PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment

Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.

A total of 1 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.

Cyclophosphamide: To deplete Tregs before collecting peripheral blood

PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment

Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.

A total of 2 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.

Cyclophosphamide: To deplete Tregs before collecting peripheral blood

PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment

Peripheral blood lymphocytes will be collected and Programmed cell death protein 1(PDCD1) gene will be knocked out by CRISPR Cas9 in the laboratory (PD-1 Knockout T cells). The lymphocytes will be selected and expanded ex vivo and infused back into patients. Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.

A total of 4 x 10^7/kg PD-1 Knockout T cells will be infused in one cycle. Each cycle is divided into three administrations, with 20% infused in the first administration, 30% in the second, and the remaining 50% in the third. Patients will receive a total of two cycles of treatment.

Cyclophosphamide: To deplete Tregs before collecting peripheral blood

PD-1 Knockout T Cells: Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment

Total of all reporting groups
Overall Number of Baseline Participants 2 4 3 3 12
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 4 participants 3 participants 3 participants 12 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
2
 100.0%
3
  75.0%
2
  66.7%
3
 100.0%
10
  83.3%
>=65 years
0
   0.0%
1
  25.0%
1
  33.3%
0
   0.0%
2
  16.7%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants 4 participants 3 participants 3 participants 12 participants
55.5
(48 to 63)
56
(48 to 66)
55
(31 to 68)
53
(47 to 61)
54.5
(31 to 68)
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 2 participants 4 participants 3 participants 3 participants 12 participants
55.5
(48 to 63)
56
(48 to 66)
55
(31 to 68)
53
(47 to 61)
54.5
(31 to 68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 4 participants 3 participants 3 participants 12 participants
Female
0
   0.0%
2
  50.0%
2
  66.7%
0
   0.0%
4
  33.3%
Male
2
 100.0%
2
  50.0%
1
  33.3%
3
 100.0%
8
  66.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 2 participants 4 participants 3 participants 3 participants 12 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
2
 100.0%
4
 100.0%
3
 100.0%
3
 100.0%
12
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
White
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 2 participants 4 participants 3 participants 3 participants 12 participants
2 4 3 3 12
1.Primary Outcome
Title Number of Participants With Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and Tolerability of Dose of PD-1 Knockout T Cells Using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in Patients
Hide Description [Not Specified]
Time Frame Dose Escalation - Approximately 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-A Cohort A Cohort B Cohort C Cohort
Hide Arm/Group Description:
All adverse events are grade 1-2.
All adverse events are grade 1-2.
All adverse events are grade 1-2.
All adverse events are grade 1-2.
Overall Number of Participants Analyzed 2 4 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
2
 100.0%
4
 100.0%
3
 100.0%
2
  66.7%
2.Secondary Outcome
Title Number of Patients With Overall Response
Hide Description Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR."
Time Frame 3 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-A Cohort A Cohort B Cohort C Cohort
Hide Arm/Group Description:
In Pre-A Cohort, all patient were assessed per RECIST v1.1
In A Cohort, 3 patients were assessed per RECIST v1.1. One patient was unavailable for tumor response assessment due to early withdrawal.
In B Cohort, all patients were assessed per RECIST v1.1.
In C Cohort, all patients were assessed per RECIST v1.1.
Overall Number of Participants Analyzed 2 3 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Number of Patients With Disease Control at 8 Weeks
Hide Description Response will be evaluated according to RECIST v1.1 for target lesions at Week 8:Complete Response (CR), Disappearance of all extranodal target lesions; Partial Response (PR) ≥ 30% decrease in the sum of diameters of target lesions; Stable Disease (SD) Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD; Disease control = CR +PR+SD
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-A Cohort A Cohort B Cohort C Cohort
Hide Arm/Group Description:
In Pre-A Cohort, all two patients were assessed per RECIST v1.1.
3 patients were assessed per RECIST v1.1. One patient was unavailable for tumor response assessment due to early withdrawal.
In B Cohort, all patients were assessed per RECIST v1.1.
All patients were assessed per RECIST v1.1.
Overall Number of Participants Analyzed 2 3 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
1
  50.0%
0
   0.0%
1
  33.3%
0
   0.0%
4.Secondary Outcome
Title Progression Free Survival (PFS)
Hide Description Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions
Time Frame The time from the date of first edited T cell infusion to the date of disease progression or death due to any reason.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-A Cohort A Cohort B Cohort C Cohort
Hide Arm/Group Description:
In Pre-A Cohort, all two patients were assessed per RECIST v1.1.
All patients were assessed per RECIST v1.1.
In B Cohort, all patients were assessed per RECIST v1.1.
All patients were assessed per RECIST v1.1.
Overall Number of Participants Analyzed 2 4 3 3
Median (95% Confidence Interval)
Unit of Measure: weeks
11.7
(5.6 to 17.7)
8.0
(7.3 to 8.4)
8.1
(7.4 to 75.7)
6.1
(5.0 to 8.1)
5.Secondary Outcome
Title Overall Survival (OS)
Hide Description OS is defined as the time interval from date of first edited T cell infusion to the date of death due to any reason
Time Frame The duration from date of first edited T cell infusion to the date of death due to any reason
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Pre-A Cohort A Cohort B Cohort C Cohort
Hide Arm/Group Description:
In Pre-A Cohort, two patients were followed up.
All patients were followed up.
In B Cohort, all patients were followed up.
All patients were followed up.
Overall Number of Participants Analyzed 2 4 3 3
Median (95% Confidence Interval)
Unit of Measure: weeks
47.5
(42.6 to 52.4)
51.4
(13.4 to 116)
32.6
(24.4 to 97.7)
51.6
(21 to 96.7)
6.Secondary Outcome
Title Number of Participants With Genes Mutations in Peripheral Blood Circulating Tumor DNA (ctDNA)
Hide Description Driver genes mutaion stauts of Participants in ctDNA from peripheral blood were assessed by next generation sequencing (NGS), to explore the positive rate of sepicif driver genes (e.g. EGFR, ALK, ROS1, etc.) and the relationship between gene mutation status and clinical response
Time Frame Baseline
Hide Outcome Measure Data
Hide Analysis Population Description
Only three patients were detected with EGFR mutations. Correlation between driver gene mutations with clinical outcome were not analyzed due to limited data. EGFR positive rate was showed in outcome measure data table.
Arm/Group Title Pre-A Cohort A Cohort B Cohort C Cohort
Hide Arm/Group Description:
All patients were tested for gene mutation status in ctDNA at baseline
All patients were tested for gene mutation status in ctDNA at baseline
All patients were tested for gene mutation status in ctDNA at baseline
All patients were tested for gene mutation status in ctDNA at baseline
Overall Number of Participants Analyzed 2 4 3 3
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
1
  25.0%
1
  33.3%
1
  33.3%
7.Secondary Outcome
Title Interleukin-6 Change in the Peripheral Blood.
Hide Description Peripheral Interleukin-6 level at different timepoint (Baseline, 1 month and 3 month) was measured using rate nephelometry
Time Frame Baseline, 1 month and 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
One patients did not provide blood sample due to early withdrawal; blood samples of 8 patients were only collected at baseline and month 1 due to PD before month 3
Arm/Group Title Pre-A Cohort A Cohort B Cohort C Cohort
Hide Arm/Group Description:
In Pre-A Cohort, one patient provided blood smaple at baseline, month 1 and month 3, the other patient provided blood sample only at baseline and month 1.
Three patients were collected blood at baseline and month 1. The other patient's sample was not collected owing to early withdrawal from the trial. All patients had relapsed disease before month 3 and were not able to samples at month 3.
In B Cohort, One patient's blood was collected at baseline, month 1 and month 3. The other two patients' sample were collected only at baseline and month 1 owing to PD before month 3.
In C Cohort, One patient's blood was collected blood at baseline, month 1 and month 3. The other two patients' blood were only collected blood at baseline and month 1, owing to PD before month 3.
Overall Number of Participants Analyzed 2 3 3 3
Median (95% Confidence Interval)
Unit of Measure: pg/ml
baseline Number Analyzed 2 participants 3 participants 3 participants 3 participants
10.68
(8.98 to 12.38)
3.27
(2.62 to 61.87)
51.97
(8.09 to 67.09)
10.59
(10.28 to 11.45)
1 month Number Analyzed 2 participants 3 participants 3 participants 3 participants
12.9
(1.5 to 24.3)
4.37
(2.39 to 90.17)
23.92
(5.58 to 137.1)
14.77
(8.48 to 26.17)
3 month Number Analyzed 1 participants 0 participants 1 participants 1 participants
18.45
(18.45 to 18.45)
4.03
(4.03 to 4.03)
12.49
(12.49 to 12.49)
8.Secondary Outcome
Title Interleukin-10 Change in the Peripheral Blood.
Hide Description Peripheral Interleukin-10 level at different timepoint (Baseline, 1 month and 3 month) was measured using chemiluminescence.
Time Frame Baseline, 1 month and 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
One patients did not provide blood sample due to early withdrawal; blood samples of 8 patients were only collected at baseline and month 1 due to PD before month 3
Arm/Group Title Pre-A Cohort A Cohort B Cohort C Cohort
Hide Arm/Group Description:
In Pre-A Cohort, one patient's blood was collected blood at baseline, month 1 and month 3, the other patient's blood was collected at baseline and month 1.
Three patients' samples were collected at baseline and month 1. The other patient's sample was not collected owing to early withdrawal from the trial. All patients had relapsed disease before month 3 and did not provide samples at month 3
In B Cohort, One patient's sample was collected at baseline, month 1 and month 3. The other two patients' samples were collected only at baseline and month 1, owing to PD before month 3.
In C Cohort, one patient's sample was collected at baseline, month 1 and month 3. The other two patients' samples were collected only at baseline and month 1, owing to PD before month 3.
Overall Number of Participants Analyzed 2 3 3 3
Median (95% Confidence Interval)
Unit of Measure: pg/ml
baseline Number Analyzed 2 participants 3 participants 3 participants 3 participants
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
1 month Number Analyzed 2 participants 3 participants 3 participants 3 participants
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
19.05
(7.3 to 30.8)
5.00
(5.00 to 5.00)
3 month Number Analyzed 1 participants 0 participants 1 participants 1 participants
5.00
(5.00 to 5.00)
27.10
(27.10 to 27.10)
5.00
(5.00 to 5.00)
9.Secondary Outcome
Title Tumor Necrosis Factor-a Change in the Peripheral Blood.
Hide Description Peripheral Tumor Necrosis Factor-a level at different timepoint (Baseline, 1 month and 3 month) was measured using chemiluminescence.
Time Frame Baseline, 1 month and 3 month
Hide Outcome Measure Data
Hide Analysis Population Description
One patients did not provide blood sample due to early withdrawal; blood samples of 8 patients were only collected at baseline and month 1 due to PD before month 3
Arm/Group Title Pre-A Cohort A Cohort B Cohort C Cohort
Hide Arm/Group Description:
In Pre-A Cohort, one patient's blood was collected at baseline, month 1 and month 3, the other patient's blood was collected only at baseline and month 1.
Three patients provided blood samples at baseline and month 1. The other patient's sample was not collected owing to early withdrawal from the trial. All patients had relapsed disease before month 3 and were not able to provide samples at month 3
In B Cohort, one patient's sample was collected at baseline, month 1 and month 3. The other two patients' sample were collected only at baseline, month 1 owing to PD before month 3.
In C Cohort, one patient's sample was collected at baseline, month 1 and month 3. The other two patients' sample were collected only at baseline, month 1 owing to PD before month 3.
Overall Number of Participants Analyzed 2 3 3 3
Median (95% Confidence Interval)
Unit of Measure: pg/ml
baseline Number Analyzed 2 participants 3 participants 3 participants 3 participants
13.84
(7.97 to 19.7)
6.07
(5.61 to 8.53)
8.89
(5.30 to 8.92)
5.06
(4.01 to 6.28)
1 month Number Analyzed 2 participants 3 participants 3 participants 3 participants
10.68
(7.65 to 13.7)
7.84
(5.74 to 7.92)
10.40
(4.2 to 11.9)
16.4
(6.31 to 27.70)
3 month Number Analyzed 1 participants 0 participants 1 participants 1 participants
6.97
(6.97 to 6.97)
10.90
(10.90 to 10.90)
11.70
(11.70 to 11.70)
Time Frame Adverse event data were collected for 2 years.
Adverse Event Reporting Description Grade 1/2 treatment-related adverse events (AEs) occurred in 11 of the 12 patients and There were no grade ≥3 treatment-related AEs
 
Arm/Group Title Pre-A Cohort A Cohort B Cohort C Cohort
Hide Arm/Group Description Grade 1/2 treatment-related adverse events (AEs) occurred in 2 patients. Grade 1/2 treatment-related adverse events (AEs) occurred in 4 patients. Grade 1/2 treatment-related adverse events (AEs) occurred in 3 patients. Grade 1/2 treatment-related adverse events (AEs) occurred in 2 patients.
All-Cause Mortality
Pre-A Cohort A Cohort B Cohort C Cohort
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/2 (0.00%)      0/4 (0.00%)      0/3 (0.00%)      0/3 (0.00%)    
Hide Serious Adverse Events
Pre-A Cohort A Cohort B Cohort C Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/2 (0.00%)      0/4 (0.00%)      0/3 (0.00%)      0/3 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Pre-A Cohort A Cohort B Cohort C Cohort
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/2 (100.00%)      4/4 (100.00%)      3/3 (100.00%)      2/3 (66.67%)    
Blood and lymphatic system disorders         
Lymphopenia * 1  1/2 (50.00%)  1 0/4 (0.00%)  0 1/3 (33.33%)  1 1/3 (33.33%)  1
Leukopenia * 1  0/2 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0
Anemia * 1  0/2 (0.00%)  0 0/4 (0.00%)  0 0/3 (0.00%)  0 1/3 (33.33%)  1
Thrombocytopenia * 1  0/2 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  1 0/3 (0.00%) 
Neutropenia * 1  0/2 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  1 0/3 (0.00%) 
Cardiac disorders         
Premature beats * 1  1/2 (50.00%)  1 0/4 (0.00%)  0 0/3 (0.00%)  0 0/3 (0.00%)  0
General disorders         
Fatigue * 1  1/2 (50.00%)  1 0/4 (0.00%)  2/3 (66.67%)  2 0/3 (0.00%) 
Hypertension * 1  1/2 (50.00%)  1 0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Fever * 1  0/2 (0.00%)  0/4 (0.00%)  2/3 (66.67%)  2 0/3 (0.00%) 
Hyperhidrosis * 1  0/2 (0.00%)  0/4 (0.00%)  1/3 (33.33%)  1 0/3 (0.00%) 
Infusion-related reaction * 1  0/2 (0.00%)  1/4 (25.00%)  1 0/3 (0.00%)  0/3 (0.00%) 
Immune system disorders         
Arthralgia * 1  0/2 (0.00%)  0 1/4 (25.00%)  1 1/3 (33.33%)  1 0/3 (0.00%)  0
Increased AST * 1  0/2 (0.00%)  0 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0
Increased ALT * 1  1/2 (50.00%)  1 0/4 (0.00%)  0/3 (0.00%)  0/3 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash * 1  1/2 (50.00%)  1 1/4 (25.00%)  1 0/3 (0.00%)  0 0/3 (0.00%)  0
1
Term from vocabulary, MedDRA 21.0
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: You Lu
Organization: West China Hospital, Sichuan University
Phone: +862885423571
EMail: 283494287@qq.com
Publications:
Layout table for additonal information
Responsible Party: You Lu, Sichuan University
ClinicalTrials.gov Identifier: NCT02793856    
Other Study ID Numbers: MHC-001
First Submitted: May 30, 2016
First Posted: June 8, 2016
Results First Submitted: April 25, 2020
Results First Posted: December 21, 2020
Last Update Posted: January 12, 2021