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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 up to 13 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial tests SYNB1891 alone or with atezolizumab in patients with severe cancers. SYNB1891 is injected into tumors to boost the immune response, and atezolizumab helps the immune system fight cancer. Atezolizumab was the first approved treatment for this purpose, showing benefits in treating certain types of lung cancer.

Eligible Conditions

Lymphoma
Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 13 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 13 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 13 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of Participants With Dose-limiting Toxicity

Secondary study objectives

Number of Participants With Best Tumor Response as Measured by the Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Number of Participants With Treatment-Emergent Adverse Events

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%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2: SYNB1891 in Combination with AtezolizumabExperimental Treatment2 Interventions

SYNB1891 was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles for up to 24 months/35 cycles. The dose of SYNB1891 in the first cohort was 1 × 10\^7 live cells and was increased in an approximately 3-fold increment to 3 × 10\^7 live cells in the second cohort. Atezolizumab was administered in accordance with its recommended dose and schedule (1200 mg IV Q3W) on Day 1 of each cycle for up to 24 months/35 cycles. On days when atezolizumab and SYNB1891 were both administered, SYNB1891 was administered first, followed by at least 1 hour of observation prior to the atezolizumab infusion.

Group II: Arm 1: SYNB1891 MonotherapyExperimental Treatment1 Intervention

SYNB1891 monotherapy was administered as an IT injection on Days 1, 8, and 15 of Cycle 1 and Day 1 of subsequent cycles for up to 24 months/35 cycles. The starting dose of SYNB1891 in the first cohort was 1 × 10\^6 live cells and was increased in approximately 3-fold increments in subsequent cohorts.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

FDA approved

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