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Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02266147
Recruitment Status : Terminated (The sponsor terminated the trial early because there was sufficient data to make a decision about SD-101 in the lymphoma development program.)
First Posted : October 16, 2014
Results First Posted : September 4, 2020
Last Update Posted : September 4, 2020
Sponsor:
Information provided by (Responsible Party):
Dynavax Technologies Corporation

Study Type Interventional
Study Design Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition B-cell Lymphoma
Interventions Drug: SD-101
Radiation: Radiation therapy
Enrollment 29
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1 mg/mL 2 mg/mL 4 mg/mL 8 mg/mL
Hide Arm/Group Description PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29

PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29
Period Title: PART 1: Dose Escalation
Started 3 3 3 4
Completed 2 0 0 0
Not Completed 1 3 3 4
Reason Not Completed
Physician Decision             0             0             1             0
Lack of Efficacy             0             2             1             1
Study Terminated by Sponsor             0             0             1             3
Other             1             1             0             0
Period Title: PART 2: Dose Expansion
Started [1] 7 [2] 0 [3] 0 [3] 9 [2]
Completed 0 0 0 0
Not Completed 7 0 0 9
Reason Not Completed
Lack of Efficacy             1             0             0             1
Study Terminated by Sponsor             6             0             0             8
[1]
Sponsor terminated the trial early during Part 2 and participants should be counted once per row.
[2]
Participants were enrolled separately from Part 1; sponsor terminated the trial early during Part 2.
[3]
No new participants were enrolled and sponsor terminated the trial early during Part 2.
Arm/Group Title 1 mg/mL 2 mg/mL 4 mg/mL 8 mg/mL Total
Hide Arm/Group Description

PART 1

COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29

Total of all reporting groups
Overall Number of Baseline Participants 10 3 3 13 29
Hide Baseline Analysis Population Description
Intent-to-treat population
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 3 participants 3 participants 13 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
7
  70.0%
2
  66.7%
2
  66.7%
7
  53.8%
18
  62.1%
>=65 years
3
  30.0%
1
  33.3%
1
  33.3%
6
  46.2%
11
  37.9%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 3 participants 3 participants 13 participants 29 participants
56.9  (13.53) 56  (9.54) 61  (16.52) 62.7  (12.32) 59.8  (12.59)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 3 participants 3 participants 13 participants 29 participants
Female
4
  40.0%
2
  66.7%
1
  33.3%
6
  46.2%
13
  44.8%
Male
6
  60.0%
1
  33.3%
2
  66.7%
7
  53.8%
16
  55.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 3 participants 3 participants 13 participants 29 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
10
 100.0%
3
 100.0%
3
 100.0%
13
 100.0%
29
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 3 participants 3 participants 13 participants 29 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
1
  10.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   3.4%
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
8
  80.0%
3
 100.0%
3
 100.0%
12
  92.3%
26
  89.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
  10.0%
0
   0.0%
0
   0.0%
1
   7.7%
2
   6.9%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 10 participants 3 participants 3 participants 13 participants 29 participants
10
 100.0%
3
 100.0%
3
 100.0%
13
 100.0%
29
 100.0%
1.Primary Outcome
Title Number of Participants Experiencing Dose-limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD).
Hide Description [Not Specified]
Time Frame Up to Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title 1 mg/mL 2 mg/mL 4 mg/mL 8 mg/mL
Hide Arm/Group Description:

PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;

PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29

PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;

PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29

Overall Number of Participants Analyzed 10 3 3 13
Measure Type: Number
Unit of Measure: participants
0 0 0 0
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 1 mg/mL, 2 mg/mL, 4 mg/mL, 8 mg/mL
Comments MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.
Type of Statistical Test Other
Comments MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.
Other Statistical Analysis MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted.
2.Primary Outcome
Title Number of Participants Experiencing Injection-site Reactions (ISRs)
Hide Description Injection site reaction 1 = Redness, Injection site reaction 2 = Swelling, Injection site reaction 3 = Pain
Time Frame Up to Day 36
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title 1 mg/mL 2 mg/mL 4 mg/mL 8 mg/mL
Hide Arm/Group Description:

PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;

PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29

PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;

PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29

Overall Number of Participants Analyzed 10 3 3 13
Measure Type: Count of Participants
Unit of Measure: Participants
Injection site reaction 1
4
  40.0%
0
   0.0%
1
  33.3%
5
  38.5%
Injection site reaction 2
4
  40.0%
1
  33.3%
2
  66.7%
2
  15.4%
Injection site reaction 3
7
  70.0%
3
 100.0%
1
  33.3%
6
  46.2%
3.Primary Outcome
Title Number of Participants Experiencing Serious Adverse Events (SAEs)
Hide Description [Not Specified]
Time Frame Up to 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population
Arm/Group Title 1 mg/mL 2 mg/mL 4 mg/mL 8 mg/mL
Hide Arm/Group Description:

PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;

PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29

PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;

PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29

Overall Number of Participants Analyzed 10 3 3 13
Measure Type: Number
Unit of Measure: participants
Renal and urinary disorders 0 0 0 1
Respiratory, thoracic and mediastinal disorders 0 0 1 0
Total # of participants with SAEs 0 0 1 1
4.Primary Outcome
Title Pharmacodynamic Profile - Expression of IFN-responsive Genes (GBP-1, ISG-54, MCP-1, and MxB)
Hide Description Fold change of IFN-responsive gene expression relative to Day 8
Time Frame Change from Day 8 to Day 9
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title 1 mg/mL 2 mg/mL 4 mg/mL 8 mg/mL
Hide Arm/Group Description:
PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29

PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29
Overall Number of Participants Analyzed 10 3 3 13
Geometric Mean (Standard Deviation)
Unit of Measure: Fold Change
7.42  (4.78) 8.06  (2.05) 9.89  (.59) 7.78  (7.54)
5.Secondary Outcome
Title Number of Participants With Preliminary Response - Local (Injected Lesions)
Hide Description Subjects with maximum decrease of 50% or greater in sum of products of diameters of lesions.
Time Frame Up to 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title 1 mg/mL 2 mg/mL 4 mg/mL 8 mg/mL
Hide Arm/Group Description:

PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;

PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29

PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;

PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29

Overall Number of Participants Analyzed 9 3 3 13
Measure Type: Count of Participants
Unit of Measure: Participants
6
  66.7%
3
 100.0%
1
  33.3%
8
  61.5%
6.Secondary Outcome
Title Number of Participants With Preliminary Response - Systemic (Non-injected Lesions)
Hide Description Subjects with maximum decrease of 50% or greater in sum of products of diameters of lesions.
Time Frame Up to 38 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title 1 mg/mL 2 mg/mL 4 mg/mL 8 mg/mL
Hide Arm/Group Description:

PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;

PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29

PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;

PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29

Overall Number of Participants Analyzed 9 3 3 13
Measure Type: Count of Participants
Unit of Measure: Participants
2
  22.2%
0
   0.0%
0
   0.0%
2
  15.4%
Time Frame Up to 38 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 mg/mL 2 mg/mL 4 mg/mL 8 mg/mL
Hide Arm/Group Description

PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29;

PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29

PART 1

COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29

PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29;

PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29

All-Cause Mortality
1 mg/mL 2 mg/mL 4 mg/mL 8 mg/mL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/3 (0.00%)   0/3 (0.00%)   0/13 (0.00%) 
Hide Serious Adverse Events
1 mg/mL 2 mg/mL 4 mg/mL 8 mg/mL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/3 (0.00%)   1/3 (33.33%)   1/13 (7.69%) 
Renal and urinary disorders         
Focal segmental glomerulosclerosis  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Respiratory, thoracic and mediastinal disorders         
Pulmonary embolism  1  0/10 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%) 
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1 mg/mL 2 mg/mL 4 mg/mL 8 mg/mL
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   10/10 (100.00%)   3/3 (100.00%)   3/3 (100.00%)   13/13 (100.00%) 
Blood and lymphatic system disorders         
Anaemia  1  1/10 (10.00%)  1/3 (33.33%)  0/3 (0.00%)  1/13 (7.69%) 
Lymphadenopathy  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/13 (7.69%) 
Neutropenia  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  3/13 (23.08%) 
Thrombocytopenia  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/13 (7.69%) 
Cardiac disorders         
Atrioventricular block first degree  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%) 
Tachycardia  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Eye disorders         
Dry eye  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Eye irritation  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Gastrointestinal disorders         
Abdominal Discomfort  1  1/10 (10.00%)  1/3 (33.33%)  0/3 (0.00%)  1/13 (7.69%) 
Abdominal pain  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Abdominal pain lower  1  0/10 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%) 
Abdominal pain upper  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Constipation  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Diarrhoea  1  3/10 (30.00%)  0/3 (0.00%)  1/3 (33.33%)  4/13 (30.77%) 
Nausea  1  2/10 (20.00%)  1/3 (33.33%)  0/3 (0.00%)  8/13 (61.54%) 
Pancreatic cyst  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Paraesthesia oral  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Stomatitis  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Swollen tongue  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Vomiting  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  5/13 (38.46%) 
General disorders         
Asthenia  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/13 (7.69%) 
Chest discomfort  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Chills  1  8/10 (80.00%)  2/3 (66.67%)  3/3 (100.00%)  13/13 (100.00%) 
Exercise tolerance decreased  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Fatigue  1  8/10 (80.00%)  3/3 (100.00%)  3/3 (100.00%)  12/13 (92.31%) 
Feeling hot  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Gait disturbance  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Influenza like illness  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%) 
Injection Site Erythema  1  4/10 (40.00%)  0/3 (0.00%)  1/3 (33.33%)  3/13 (23.08%) 
Injection Site Swelling  1  3/10 (30.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%) 
Injection site discolouration  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Injection site pain  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%) 
Injection site pruritus  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Injection site rash  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Local swelling  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Malaise  1  9/10 (90.00%)  2/3 (66.67%)  3/3 (100.00%)  13/13 (100.00%) 
Oedema  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Oedema peripheral  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Peripheral swelling  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Pyrexia  1  4/10 (40.00%)  1/3 (33.33%)  2/3 (66.67%)  12/13 (92.31%) 
Hepatobiliary disorders         
Hyperbilirubinaemia  1  0/10 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  0/13 (0.00%) 
Immune system disorders         
Food allergy  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Infections and infestations         
Bronchitis  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Herpes virus infection  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Nasopharyngitis  1  1/10 (10.00%)  2/3 (66.67%)  0/3 (0.00%)  1/13 (7.69%) 
Pneumonia  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Upper respiratory tract infection  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/13 (7.69%) 
Urinary tract infection  1  0/10 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  1/13 (7.69%) 
Viral infection  1  1/10 (10.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%) 
Injury, poisoning and procedural complications         
Excoriation  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Post procedural haematoma  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Post-traumatic neck syndrome  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%) 
Investigations         
Aspartate aminotransferase increased  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Blood bilirubin increased  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Blood calcium decreased  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%) 
Blood chloride increased  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%) 
Dna antibody positive  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Eosinophil count decreased  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%) 
Gamma-glutamyltransferase increased  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Lymphocyte count decreased  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%) 
Lymphocyte count increased  1  0/10 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%) 
Neutrophil count decreased  1  2/10 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Neutrophil count increased  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Platelet count decreased  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Protein total decreased  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%) 
White blood cell count decreased  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Metabolism and nutrition disorders         
Decreased appetite  1  2/10 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%) 
Hyperglycaemia  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Hyperuricaemia  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Hypoalbuminaemia  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Back pain  1  0/10 (0.00%)  1/3 (33.33%)  1/3 (33.33%)  1/13 (7.69%) 
Medial tibial stress syndrome  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Muscle spasms  1  2/10 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Musculoskeletal chest pain  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Musculoskeletal stiffness  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Myalgia  1  7/10 (70.00%)  3/3 (100.00%)  3/3 (100.00%)  13/13 (100.00%) 
Neck pain  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/13 (7.69%) 
Pain in extremity  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Haemangioma  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Nervous system disorders         
Dizziness  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Dysgeusia  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%) 
Headache  1  8/10 (80.00%)  3/3 (100.00%)  3/3 (100.00%)  11/13 (84.62%) 
Hypoaesthesia  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Parosmia  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Presyncope  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Psychiatric disorders         
Anxiety  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Confusional state  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Disorientation  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Insomnia  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Renal and urinary disorders         
Hypertonic bladder  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%) 
Pollakiuria  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Proteinuria  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Urinary incontinence  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Reproductive system and breast disorders         
Menstruation irregular  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Cough  1  1/10 (10.00%)  1/3 (33.33%)  0/3 (0.00%)  2/13 (15.38%) 
Dyspnoea  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Increased viscosity of bronchial secretion  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Nasal congestion  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%) 
Oropharyngeal Pain  1  2/10 (20.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%) 
Paranasal sinus hypersecretion  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  0/13 (0.00%) 
Pleuritic pain  1  0/10 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%) 
Sinus congestion  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%) 
Sneezing  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Upper-airway cough syndrome  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Skin and subcutaneous tissue disorders         
Cold sweat  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Cutis laxa  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Erythema  1  1/10 (10.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%) 
Hyperhidrosis  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  1/13 (7.69%) 
Night Sweats  1  3/10 (30.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%) 
Rash  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%) 
Rash maculo-papular  1  0/10 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%) 
Skin hyperpigmentation  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Skin mass  1  0/10 (0.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%) 
Skin ulcer  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
Vascular disorders         
Deep vein thrombosis  1  0/10 (0.00%)  0/3 (0.00%)  1/3 (33.33%)  0/13 (0.00%) 
Haematoma  1  1/10 (10.00%)  0/3 (0.00%)  0/3 (0.00%)  2/13 (15.38%) 
Hot flush  1  1/10 (10.00%)  1/3 (33.33%)  0/3 (0.00%)  0/13 (0.00%) 
Hypotension  1  0/10 (0.00%)  0/3 (0.00%)  0/3 (0.00%)  1/13 (7.69%) 
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
The sponsor terminated the trial early because there was sufficient data to make a decision about SD-101 in the lymphoma development program.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Robert Janssen MD \ VP & Chief Medical Officer
Organization: Dynavax Technologies, Inc.
Phone: 510-665-0414
EMail: rjanssen@dynavax.com
Layout table for additonal information
Responsible Party: Dynavax Technologies Corporation
ClinicalTrials.gov Identifier: NCT02266147    
Other Study ID Numbers: DV3-LYM-01
First Submitted: October 13, 2014
First Posted: October 16, 2014
Results First Submitted: June 29, 2020
Results First Posted: September 4, 2020
Last Update Posted: September 4, 2020