STI-6129 for Light Chain (AL) Amyloidosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Light Chain (AL) Amyloidosis+4 More
STI-6129 - Biological
Eligibility
18+
All Sexes
What conditions do you have?
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Study Summary

This trial is designed to find the best dose of STI-6129 to treat relapsed or refractory systemic AL amyloidosis while also assessing its safety and preliminary efficacy.

Eligible Conditions
  • Light Chain (AL) Amyloidosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Light Chain (AL) Amyloidosis

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline through study completion at up to 14 months

Month 14
Correlation of treatment response (organ responses and hematological response) with disease severity based on the 2012 revised Mayo Clinic staging system for AL amyloidosis
Organ response rates (cardiac, renal, hepatic, peripheral nervous system) according to the 2012 Consensus Round Table response criteria
Overall hematological response rate according to the 2012 Consensus Round Table response criteria
Safety and tolerability of STI-6129 in AL amyloidosis patients
Day 63
Plasma levels of the total antibody plus conjugated toxin (STI-6129) and the free toxin (Duostatin 5.2)

Trial Safety

Safety Progress

1 of 3

Other trials for Light Chain (AL) Amyloidosis

Side Effects for

Arm D (Phase II Randomization): BR in DLBCL
54%NEUTROPENIA
49%THROMBOCYTOPENIA
49%ANAEMIA
41%DIARRHOEA
36%FATIGUE
31%NAUSEA
26%PYREXIA
26%DECREASED APPETITE
23%NEUROPATHY PERIPHERAL
18%VOMITING
18%CONSTIPATION
15%COUGH
15%PERIPHERAL SENSORY NEUROPATHY
13%DIZZINESS
13%ARTHRALGIA
13%LYMPHOPENIA
13%ABDOMINAL PAIN UPPER
13%LEUKOPENIA
13%WEIGHT DECREASED
13%HYPOALBUMINAEMIA
13%PRURITUS
10%FEBRILE NEUTROPENIA
10%CHILLS
10%HYPOKALAEMIA
10%ASTHENIA
10%PNEUMONIA
10%PLATELET COUNT DECREASED
8%ABDOMINAL PAIN
8%DYSPEPSIA
8%STOMATITIS
8%HEADACHE
8%HYPOCALCAEMIA
8%ANXIETY
8%INSOMNIA
8%LIPASE INCREASED
8%DYSPNOEA
5%OEDEMA PERIPHERAL
5%UPPER RESPIRATORY TRACT INFECTION
5%PAIN
5%TACHYCARDIA
5%SYNCOPE
5%OROPHARYNGEAL PAIN
5%HAEMATEMESIS
5%PAIN IN EXTREMITY
5%PRODUCTIVE COUGH
5%HYPOPHOSPHATAEMIA
5%HYPOAESTHESIA
5%HYPOTENSION
5%NECK PAIN
5%RASH
5%ORAL CANDIDIASIS
5%PNEUMONITIS
5%GASTROOESOPHAGEAL REFLUX DISEASE
5%PARAESTHESIA
5%SEPSIS
5%MUSCULAR WEAKNESS
5%MUSCLE SPASMS
5%OEDEMA
5%HERPES VIRUS INFECTION
5%ASPARTATE AMINOTRANSFERASE INCREASED
5%BLOOD CREATININE INCREASED
5%DEHYDRATION
5%HYPERTENSION
5%DUODENAL ULCER HAEMORRHAGE
3%INFECTION
3%ABDOMINAL DISTENSION
3%MENINGOENCEPHALITIS HERPETIC
3%BACK PAIN
3%HYDRONEPHROSIS
3%NASOPHARYNGITIS
3%FALL
3%BLOOD ALKALINE PHOSPHATASE INCREASED
3%WHITE BLOOD CELL COUNT DECREASED
3%GINGIVAL PAIN
3%PULMONARY EMBOLISM
3%CEREBRAL TOXOPLASMOSIS
3%PNEUMOCYSTIS JIROVECII PNEUMONIA
3%SQUAMOUS CELL CARCINOMA
3%VOCAL CORD PARALYSIS
3%RENAL FAILURE
3%FLATULENCE
3%INFUSION RELATED REACTION
3%CELLULITIS
3%MUSCULOSKELETAL CHEST PAIN
3%TREMOR
3%HYPERURICAEMIA
3%MUSCULOSKELETAL PAIN
3%DYSGEUSIA
3%ACUTE KIDNEY INJURY
3%POLLAKIURIA
3%PLEURAL EFFUSION
3%HYPERGLYCAEMIA
3%UPPER-AIRWAY COUGH SYNDROME
3%URTICARIA
3%DEEP VEIN THROMBOSIS
3%GAIT DISTURBANCE
3%GASTROINTESTINAL BACTERIAL INFECTION
3%RHINOVIRUS INFECTION
3%MALIGNANT MELANOMA
3%HAEMORRHAGE INTRACRANIAL
3%CYSTITIS
3%CYTOMEGALOVIRUS INFECTION
3%BLOOD PHOSPHORUS DECREASED
3%MYELODYSPLASTIC SYNDROME
3%DRY MOUTH
3%DYSPNOEA EXERTIONAL
3%LIP DRY
3%CHEST DISCOMFORT
3%CONFUSIONAL STATE
3%PNEUMONIA CYTOMEGALOVIRAL
3%UROSEPSIS
3%BLOOD MAGNESIUM DECREASED
3%PULMONARY OEDEMA
3%PANCYTOPENIA
3%HYPOGAMMAGLOBULINAEMIA
3%SINUSITIS
3%DEPRESSION
3%AMYLASE INCREASED
3%MORAXELLA TEST POSITIVE
3%TRANSAMINASES INCREASED
3%BRONCHITIS
3%ALANINE AMINOTRANSFERASE INCREASED
3%HYPOMAGNESAEMIA
3%RHINORRHOEA
3%EAR PAIN
3%HUMAN ANAPLASMOSIS
3%PNEUMONIA PNEUMOCOCCAL
3%HAEMOPTYSIS
3%DISTRIBUTIVE SHOCK
3%HERPES ZOSTER
3%URINARY TRACT INFECTION
3%LYMPHOCYTE COUNT DECREASED
3%NEUTROPHIL COUNT DECREASED
3%MYALGIA
3%HYPOXIA
3%DRY SKIN
3%RASH MACULO-PAPULAR
3%DYSPHAGIA
3%CHEST PAIN
3%ERECTILE DYSFUNCTION
3%HICCUPS
3%OBSTRUCTION GASTRIC
This histogram enumerates side effects from a completed 2021 Phase 1 & 2 trial (NCT02257567) in the Arm D (Phase II Randomization): BR in DLBCL ARM group. Side effects include: NEUTROPENIA with 54%, THROMBOCYTOPENIA with 49%, ANAEMIA with 49%, DIARRHOEA with 41%, FATIGUE with 36%.

Trial Design

1 Treatment Group

STI-6129 infusion
1 of 1
Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: STI-6129 · No Placebo Group · Phase 1 & 2

STI-6129 infusion
Biological
Experimental Group · 1 Intervention: STI-6129 · Intervention Types: Biological

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through study completion at up to 14 months

Who is running the clinical trial?

Sorrento Therapeutics, Inc.Lead Sponsor
46 Previous Clinical Trials
2,449 Total Patients Enrolled
Suzanne Lentzsch, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
60 Total Patients Enrolled
Jeffrey Zonder, MDPrincipal InvestigatorBarbara Ann Karmanos Cancer Institute Wertz Clinic
1 Previous Clinical Trials
23 Total Patients Enrolled
Michael Rosenzweig, MDPrincipal InvestigatorCity of Hope National Medical Center
Vaishali Sanchorawala, MDPrincipal InvestigatorBoston Medical Center
10 Previous Clinical Trials
10,284 Total Patients Enrolled
Anita D'Souza, MDPrincipal InvestigatorFroedtert Hospital & the Medical College of Wisconsin
1 Previous Clinical Trials
32 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 8 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 28th, 2021

Last Reviewed: October 30th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.