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

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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

View this study on Beta.ClinicalTrials.gov

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

Participant Flow

Recruitment Details
Pre-assignment Details


Arm/Group Title	1 mg/mL	2 mg/mL	4 mg/mL	8 mg/mL
Arm/Group Description	PART 1: COHORT 1: 1 mg/mL at Days 1...	PART 1 ...	PART 1 ...	PART 1: COHORT 4: 8 mg/mL at Days 1...
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.

Baseline Characteristics

Arm/Group Title		1 mg/mL	2 mg/mL	4 mg/mL	8 mg/mL	Total
Arm/Group Description		PART 1 ...	PART 1 ...	PART 1 ...	PART 1 ...	Total of all reporting groups
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
Baseline Analysis Population Description		...
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
United States		10 100.0%	3 100.0%	3 100.0%	13 100.0%	29 100.0%

Outcome Measures

1.Primary Outcome


Title	Number of Participants Experiencing Dose-limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD).
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to Day 36

Outcome Measure Data

Analysis Population Description

Safety population


Arm/Group Title	1 mg/mL	2 mg/mL	4 mg/mL	8 mg/mL
Arm/Group Description:	PART 1: COHORT 1: 1 mg/mL at Days 1...	PART 1 ...	PART 1 ...	PART 1: COHORT 4: 8 mg/mL at Days 1...
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

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)
Description	Injection site reaction 1 = Redness, Injection site reaction 2 = Swell...
Description	Injection site reaction 1 = Redness, Injection site reaction 2 = Swelling, Injection site reaction 3 = Pain
Time Frame	Up to Day 36

Outcome Measure Data

Analysis Population Description

Safety population


Arm/Group Title	1 mg/mL	2 mg/mL	4 mg/mL	8 mg/mL
Arm/Group Description:	PART 1: COHORT 1: 1 mg/mL at Days 1...	PART 1 ...	PART 1 ...	PART 1: COHORT 4: 8 mg/mL at Days 1...
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)
Description	[Not Specified]
Description	[Not Specified]
Time Frame	Up to 38 weeks

Outcome Measure Data

Analysis Population Description

Safety population


Arm/Group Title	1 mg/mL	2 mg/mL	4 mg/mL	8 mg/mL
Arm/Group Description:	PART 1: COHORT 1: 1 mg/mL at Days 1...	PART 1 ...	PART 1 ...	PART 1: COHORT 4: 8 mg/mL at Days 1...
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)
Description	Fold change of IFN-responsive gene expression relative to Day 8
Description	Fold change of IFN-responsive gene expression relative to Day 8
Time Frame	Change from Day 8 to Day 9

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	1 mg/mL	2 mg/mL	4 mg/mL	8 mg/mL
Arm/Group Description:	PART 1: COHORT 1: 1 mg/mL at Days 1...	PART 1 ...	PART 1 ...	PART 1: COHORT 4: 8 mg/mL at Days 1...
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)
Description	Subjects with maximum decrease of 50% or greater in sum of products of...
Description	Subjects with maximum decrease of 50% or greater in sum of products of diameters of lesions.
Time Frame	Up to 38 weeks

Outcome Measure Data

Analysis Population Description

ITT population


Arm/Group Title	1 mg/mL	2 mg/mL	4 mg/mL	8 mg/mL
Arm/Group Description:	PART 1: COHORT 1: 1 mg/mL at Days 1...	PART 1 ...	PART 1 ...	PART 1: COHORT 4: 8 mg/mL at Days 1...
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)
Description	Subjects with maximum decrease of 50% or greater in sum of products of...
Description	Subjects with maximum decrease of 50% or greater in sum of products of diameters of lesions.
Time Frame	Up to 38 weeks

Outcome Measure Data

Analysis Population Description

ITT population


Arm/Group Title	1 mg/mL	2 mg/mL	4 mg/mL	8 mg/mL
Arm/Group Description:	PART 1: COHORT 1: 1 mg/mL at Days 1...	PART 1 ...	PART 1 ...	PART 1: COHORT 4: 8 mg/mL at Days 1...
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%

Adverse Events

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
Arm/Group Description	PART 1: COHORT 1: 1 mg/mL at Days 1...	PART 1 ...	PART 1 ...	PART 1: COHORT 4: 8 mg/mL at Days 1...
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%)
Serious Adverse Events 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
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

Limitations and Caveats

The sponsor terminated the trial early because there was sufficient data to make a decision about SD-101 in the lymphoma development program.

More Information

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

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Name/Title:	Robert Janssen MD \ VP & Chief Medical Officer
Organization:	Dynavax Technologies, Inc.
Phone:	510-665-0414
EMail:	rjanssen@dynavax.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Mooney KL, Czerwinski DK, Shree T, Frank MJ, Haebe S, Martin BA, Testa S, Levy R, Long SR. Serial FNA allows direct sampling of malignant and infiltrating immune cells in patients with B-cell lymphoma receiving immunotherapy. Cancer Cytopathol. 2022 Mar;130(3):231-237. doi: 10.1002/cncy.22531. Epub 2021 Nov 15.

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

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