AzTrials
AzTrials

B-cell LymphomaPhase 1/2NCT02266147

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

A Phase 1/2 study testing SD-101 and Radiation therapy in people with B-cell Lymphoma, run by Dynavax Technologies Corporation at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

To assess the safety and tolerability of escalating doses of SD-101 in combination with localized low-dose radiation therapy in adult subjects with untreated low-grade B-cell lymphoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
B-cell Lymphoma
What is being tested?
SD-101 and Radiation therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
29 participants
Where
5 sitesUnited States
Study dates
Oct 2014to Apr 2017
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Biopsy confirmed, untreated, low-grade B-cell lymphoma, including follicular (Grade 1, 2, or 3A) [Harris, Swerdlow et al. 2008] or marginal, or CLL/SLL with lymph node involvement.
  • At least 2 sites of measurable disease per Cheson criteria (must measure at least 1.5 cm in any diameter or 1.0 cm in the shortest diameter if one of the diameters is not ≥ 1.5 cm), one of which must be palpable and easily accessible in a low-risk site (eg, inguinal, axillary, cervical, subcutaneous) for intratumoral injection (denoted as "Lesion A" in Treatment Cycle 1) and at least one additional untreated lesion that is located outside the radiation field of the treated lesion (Lesion A) and is accessible for an FNA aspirate.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
  • Aged 18 years and older
  • Absolute neutrophil count (ANC) ≥ 1500/mm3
  • Platelet count > 100,000/µL
Show all 13Show fewer
  • Serum creatinine (Cr) ≤ 1.5 x upper limit of normal (ULN).
  • Serum total bilirubin ≤ 1.5 x the ULN.
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • International normalized ratio or prothrombin time (PT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy and the PT or partial thromboplastin time (PTT) must be within the therapeutic range of the intended use of anticoagulants.
  • Activated PTT (aPTT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy, and the PT or PTT is within therapeutic range of intended use of anticoagulants.
  • Female subjects must have a negative urine or serum pregnancy test within 72 hours prior to taking study medication if of childbearing potential as defined in this protocol. Women of childbearing potential (WOCBP) must be willing to use 2 medically acceptable method of contraceptive from Day 1 through 120 days after the last dose of trial treatment. The 2 medically acceptable birth control methods can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), cooper intrauterine device, sponge, or spermicide as per local regulations or guidelines. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents).
  • Ability to understand and sign informed consent form (ICF) and comply with treatment protocol

Who cannot join

  • Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy (including immune modulators or systemic corticosteroids) within 7 days prior to study enrollment.
  • Positive for hepatitis B (HBsAg reactive), HCV ribonucleic acid (RNA) qualitative, or human immunodeficiency virus (HIV)( HIV 1/2 antibodies)
  • Diagnosis of mantle or diffuse large-cell lymphoma, Grade 3B follicular lymphoma [Harris, Swerdlow et al. 2008] or gastric mucosa-associated lymphoid tissue (MALT) lymphoma
  • Clinically significant pleural effusion
  • Active infection including cytomegalovirus
  • Pregnant or breast feeding within the projected duration of trial participation through 4 months after the last dose of study treatment.
Show all 17Show fewer
  • Autoimmune disease including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjӧgren's syndrome, autoimmune thrombocytopenia, history of uveitis, or other if clinically significant
  • Lymphoma involvement of the central nervous system
  • Received any prior therapy for lymphoma
  • Use of any investigational agent within the last 28 days
  • Serious, non-healing wound, ulcer, or bone fracture.
  • If a subject received major surgery, must have recovered adequately from the toxicity and/or complications from the intervention prior to enrollment.
  • Clinically significant cardiovascular disease (eg, uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication within 1 year prior to Day -1 (Visit 1); Grade II or greater peripheral vascular disease at study entry
  • Any other significant medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for this study
  • History of sensitivity to any component of SD-101
  • A diagnosis of cancer within the last 3 years prior to enrollment or any known additional malignancy that is progressing or requires active treatment. Exceptions are B-cell lymphoma, basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer.
  • Is taking systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University School of Medicine

    Stanford, California, 94305-5151

Other trials in United States

About this study

Official title: A Phase 1/2, Non-randomized, Open-label, Multicenter, Dose Escalation and Expansion Study of Intratumoral Injections of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma

To assess the safety and tolerability of escalating doses of SD-101 in combination with localized low-dose radiation therapy in adult subjects with untreated low-grade B-cell lymphoma.

Conditions
B-cell Lymphoma
Being tested
SD-101, Radiation therapy
Keywords
Low Grade B-cell Lymphoma
Medical subject headings
Lymphoma, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SD-101Drug

  • Radiation therapyRadiation

Study groups in NCT02266147
Study groupRoleWhat they receive
SD-101 in combination with low-dose radiationExperimentalPART 1 * Radiation: 2 fractions of 2 Gy over 2 days at Days -1 and 1 * COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 * COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29 * COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29 * COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29 PART 2 Cycle 1: Required * Radiation: 2 fractions of 2 Gy over 2 days at Days -1 and 1 * COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 * COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29 Cycle 2: Optional * Radiation: 2 fractions of 2 Gy over 2 days at Days 180 and 181 * COHORT 1: 1 mg/mL at Days 181, 188, 195, 202, and 209 * COHORT 2: 8 mg/mL at Days 181, 188, 195, 202, and 209
Receives: Drug: SD-101; Radiation: Radiation therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants Experiencing Dose-limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD).

    Measured: Up to Day 36

  2. Number of Participants Experiencing Injection-site Reactions (ISRs)

    Injection site reaction 1 = Redness, Injection site reaction 2 = Swelling, Injection site reaction 3 = Pain

    Measured: Up to Day 36

  3. Number of Participants Experiencing Serious Adverse Events (SAEs)

    Measured: Up to 38 weeks

  4. Pharmacodynamic Profile - Expression of IFN-responsive Genes (GBP-1, ISG-54, MCP-1, and MxB)

    Fold change of IFN-responsive gene expression relative to Day 8

    Measured: Change from Day 8 to Day 9

Secondary outcomes (2)

  1. Number of Participants With Preliminary Response - Local (Injected Lesions)

    Subjects with maximum decrease of 50% or greater in sum of products of diameters of lesions.

    Measured: Up to 38 weeks

  2. Number of Participants With Preliminary Response - Systemic (Non-injected Lesions)

    Subjects with maximum decrease of 50% or greater in sum of products of diameters of lesions.

    Measured: Up to 38 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Oct 2014 (estimated)
  2. Study startOct 2014
  3. Primary completionApr 2017
  4. Study completionApr 2017

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

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Intervention model
Sequential
Masking
None (open label)
Enrolment
29 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02266147
Sponsor's protocol ID
DV3-LYM-01
Status last verified
Aug 2020
First submitted
13 Oct 2014
Last updated
4 Sep 2020
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34780125

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SD-101 and Radiation therapy in people with B-cell Lymphoma, run by Dynavax Technologies Corporation at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 4 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Sep 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants Experiencing Dose-limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD). (time frame: Up to Day 36). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02266147, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in