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Virus Therapy

SYNB1891 for Lymphoma

Phase 1
Waitlist Available
Research Sponsored by Synlogic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monitored continuously from time of informed consent signing through the safety follow-up visit which occurs 30 ± 5 days after the last dose of study treatment (up to 26 months).
Awards & highlights

Study Summary

This trial will evaluate the safety and efficacy of SYNB1891, given as intratumoral injections, in people with advanced/metastatic solid tumors or lymphoma.

Eligible Conditions
  • Lymphoma
  • Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~monitored continuously from time of informed consent signing through the safety follow-up visit which occurs 30 ± 5 days after the last dose of study treatment (up to 26 months).
This trial's timeline: 3 weeks for screening, Varies for treatment, and monitored continuously from time of informed consent signing through the safety follow-up visit which occurs 30 ± 5 days after the last dose of study treatment (up to 26 months). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of dose-limiting toxicities (DLTs)
Secondary outcome measures
Nature, incidence and severity of all adverse events (AEs) and serious adverse events (SAEs)
Objective response rate (ORR)

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: SYNB1891 in Combination with AtezolizumabExperimental Treatment2 Interventions
Once the MTD has been established in Arm 1, dosing of SYNB1891 will begin in Arm 2 at a 10-fold lower dose than the Arm 1 maximum tolerated dose (MTD) and will be increased in approximately 3-fold increments in subsequent cohorts until recommended Phase 2 dose (RP2D) determination. SYNB1891 is to be administered in the same manner and frequency as Arm 1. Atezolizumab will be administered in accordance with its recommended dose and schedule (1200 mg IV every 3 weeks) on day 1 of each of the 4 planned cycles. On days when atezolizumab and SYNB1891 are both administered, SYNB1891 will be administered first, followed by at least 1 hour of observation prior to the atezolizumab infusion. Combination doses will not be escalated above the SYNB1891 single-agent MTD established in Arm 1. Patients without progressive disease at the end of cycle 4 may receive additional cycles of SYNB1891 and atezolizumab on day 1 of each cycle for up to 24 months after initial dose of study treatment.
Group II: Arm 1: SYNB1891 MonotherapyExperimental Treatment1 Intervention
SYNB1891 is to be administered as an intratumoral injection in up to four 21-day cycles of escalating doses on days 1, 8 and 15 of cycle 1 and day 1 of cycles 2-4. The starting dose of SYNB1891 in the first cohort will be 1 × 10^6 live cells and will be increased in approximately 3-fold increments in subsequent cohorts until MTD determination. A de-escalation dose of 3 × 10^5 live cells is available if the starting dose is deemed not tolerable. Patients without progressive disease at the end of cycle 4 may receive additional cycles of SYNB1891 on day 1 of each cycle for up to 24 months after initial dose of study treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved

Find a Location

Who is running the clinical trial?

IQVIA BiotechIndustry Sponsor
19 Previous Clinical Trials
5,338 Total Patients Enrolled
SynlogicLead Sponsor
9 Previous Clinical Trials
430 Total Patients Enrolled
Richard Riese, MDStudy DirectorSynlogic

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals still join this research endeavor?

"The clinical trial, which was initially listed on November 1st 2019 and last modified on May 11th 2021 is currently recruiting participants. This information can be found at the website: clinicaltrials.gov"

Answered by AI

What have been the safety findings of SYNB1891 in clinical trials?

"The clinical data for SYNB1891 is still limited and thus it was assigned a safety score of 1. This trial is currently in Phase 1, so further research needs to be done before efficacy can be confirmed."

Answered by AI

What is the size of the sample population involved in this research?

"70 study volunteers that meet the particular inclusion criteria must join this trial. Recruitment is occuring at University of Pittsburgh in Pittsburg, Pennsylvania as well Mary Crowley Cancer Research in Dallas, Texas."

Answered by AI

Is this experimental research novel in its approach?

"To date, 350 active trials of SYNB1891 have been launched in 1646 cities and 74 countries. In 2008, Hoffmann-La Roche conducted the first clinical trial for this drug with 720 participants successfully passing through Phase 2 approval stage. Over the past decade, 80 studies concerning this pharmaceutical have concluded their examinations."

Answered by AI

What therapeutic purpose does SYNB1891 have?

"SYNB1891 has been traditionally used to manage small cell lung cancer, but it can also be prescribed for other malignant neoplasms, non-small cell lung carcinoma and postoperative treatments."

Answered by AI

How wide-spread is the implementation of this study?

"The University of Pittsburgh, Mary Crowley Cancer Research, MD Anderson Cancer Center are among the medical centres recruiting patients for this clinical trial. Additionally, 4 other sites in various locations have been identified to recruit participants."

Answered by AI

Are there any other tests with results that can be compared to the ones collected from SYNB1891?

"The first exploration of SYNB1891 took place in 2008 at SCRI Tennessee Oncology Chattanooga. Since then, 80 clinical trials have been concluded while 350 are presently ongoing with much of the research happening out of Pittsburgh, Pennsylvania."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
Mary Crowley Cancer Research
What portion of applicants met pre-screening criteria?
Did not meet criteria

Why did patients apply to this trial?

I am healthy volunteer seeking to help aide the pharmaceutical industry.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Safety and Tolerability of SYNB1891 Injection Alone or in Combination With Atezolizumab in Adult Subjects
2019. "Safety and Tolerability of SYNB1891 Injection Alone or in Combination With Atezolizumab in Adult Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04167137.
~13 spots leftby Apr 2025
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