A Phase 1 interventional study of Neihulizumab (ALTB-168) in Steroid-refractory Acute Graft-versus-Host Disease and Treatment-refractory Acute Graft-versus-Host Disease, sponsored by AltruBio Inc.. Completed at 13 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2023-01-19.
Sponsored by AltruBio Inc. · Phase 1, Interventional, and Treatment
Among 454 studies in Graft vs Host Disease with a site in United States — 50 open to participants now, 71 under way, 2 of them phase 3. Graft vs Host Disease · United States.
Among the 454 studies in Graft vs Host Disease with a site in United States, this one is the 157th largest by enrollment of the 389 interventional ones that give a count, is one of 15 that started in 2018, is one of 90 in phase 1, and was the 337th registered.
804 studies on the registry are indexed under Graft vs Host Disease; 149 are open to participants now.
Browse Graft vs Host Disease studies →50 of the 454 studies in Graft vs Host Disease with a site in United States are open now. Recruiting first, the newest first:
City of Hope Medical Center · Sites in United States
Memorial Sloan Kettering Cancer Center · Sites in United States
Regenerative Ocular Immunobiologics LLC · Sites in United States
Northwell Health · Sites in United States
Sawa Ito, MD · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 103 Graft vs Host Disease studies recruiting now, 51 (50%) set no upper age limit and 42 (41%) stop at 75 or younger; 42 take children under 18; 9 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
454 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 145 · Phase 2 227 · Phase 3 48 · Phase 4 5
First in 1986; this study’s year is marked. 15 started in 2018.
This study's enrollment of 37 is close to the median of 35 across 639 interventional studies indexed under Graft vs Host Disease.
Median enrollment 30 across the 389 interventional studies, 81 across the 43 observational. Of the 347 that completed or were terminated, 166 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
80 of 454 have an industry lead sponsor. The 10 most frequent:
AltruBio Inc. is the lead sponsor of 5 studies on the registry; none are open to participants now.
AltruBio Inc. has 1 study filed under Graft vs Host Disease — fewer than ten, so there is no comparison to draw.
21 of the studies in Graft vs Host Disease with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07776210Phase 3Regenerative Ocular Immunobiologics LLCStudy of d-MAPPS™ Ophthalmic Solution in Adults With Chronic Ocular Graft-Versus-Host Disease (oGVHD) | 2027-03-31 |
| NCT06649201Case Comprehensive Cancer CenterVulvovaginal Graft-versus-Host Disease: Diagnosis and Microbiome Evaluation | 2026-11 |
| NCT05675930Memorial Sloan Kettering Cancer CenterA Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant | 2026-12-22 |
| NCT04044365National Cancer Institute (NCI)Pediatric cGVHD Symptom Scale | 2026-12-31 |
| NCT03533816University of Kansas Medical CenterExpanded/Activated Gamma Delta T-cell Infusion Following Hematopoietic Stem Cell Transplantation and Post-transplant Cyclophosphamide | 2027-01 |
Among the 454 studies in Graft vs Host Disease with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
A Phase I study to establish the pharmacokinetics, pharmacodynamics, safety and efficacy profiles of Neihulizumab in patients with steroid-refractory or treatment refractory acute graft-versus-host disease (SR/TR-aGVHD)
Neihulizumab (ALTB-168) is an immune checkpoint agonist antibody that regulates T cell homeostasis. The unique mechanism of action provides a natural regulation of T cell homeostasis that induces cell death preferentially in late-stage activated T cells without affecting resting T cells and early-activated T cells. Because pathogenic T cells underlying the inflammatory conditions are usually in late-stage activated state, eliminating this population of cells can potentially result in controlling autoimmune inflammation of T cell associated diseases, such as GvHD.
Inclusion Criteria (must meet all of the following criteria):
Patients must have clinical aGVHD and pathologic findings consistent with the diagnosis by of at least 1 involved site, and
Exclusion Criteria (may not meet any of the following criteria):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GVHD (graft-versus-host disease)
After a transplant from a donor, the donor’s immune cells attack the recipient’s body, often the skin, gut or liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Karnofsky performance status (KPS)
A 0–100 scale of how well someone can carry out everyday activities. 100 is no complaints and no signs of illness; 70 is able to look after yourself but not to work or keep up normal activity; 50 is needing considerable help and frequent medical care.
Studies often ask for 60 or 70 and above. Your doctor gives the score.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravenous doses of Neihulizumab (ALTB-168)
Biological: Neihulizumab (ALTB-168)
Single dose phase: Patients will receive single dose of Neihulizumab based on the protocol escalation criteria. Multiple dose phase: Parients will receive weekly doses of Neihulizumab for 4 weeks.
Pharmacokinetics of Neihulizumab - AUC
Including AUC0-t, AUC0-tz, AUC 0-inf
Time frame: Up to Day 56
Pharmacokinetics of Neihulizumab - Cmax
Maximum plasma concentration
Time frame: Up to Day 56
Pharmacokinetics of Neihulizumab - tmax
Time to reach Cmax
Time frame: Up to Day 56
Pharmacokinetics of Neihulizumab - Lambda-z
Terminal phase elimination rate constant
Time frame: Up to Day 56
Pharmacokinetics of Neihulizumab - t1/2
Half life
Time frame: Up to Day 56
Pharmacokinetics of Neihulizumab - MRT
Mean Residence Time
Time frame: Up to Day 56
Pharmacokinetics of Neihulizumab - Vz and Vss
Volume of distribution and volume of distribution at steady state
Time frame: Up to Day 56
Adverse Events (AEs)
AEs graded according to CTCAE v4.03
Time frame: Up to Day 180
To measure the Receptor Occupancy (RO)
Receptor occupancy will be monitored using a flow cytometry based method
Time frame: Up to Day 56
To measure regenerating islet-derived 3-alpha (REG3α) and suppression of tumorigenicity 2 (ST2) as Pharmacodynamics (PD) biomarkers.
Receptor occupancy will be monitored using a flow cytometry based method
Time frame: Up to Day 56
Complete Response (CR)
To assess the rate of complete response (CR) at Day 28 in patients treated with Neihulizumab
Time frame: Day 28
Overall Response Rate (ORR)
To assess the Overall Response Rate (ORR) at Day 28: CR+PR
Time frame: Day 28
Duration of Response
For subjects with CR at Day 28, duration of response will be assessed according to the time interval from Day 28 to the first occurrence of (1) resumption of Neihulizumab administration or initiation of new systemic treatment for aGvHD or (for patients who have tapered steroids) an increase in corticosteroids to methylprednisolone 2 mg/kg (+/-10%) equivalent or more, or (2) death.
Time frame: Up to Day 180
Non Relapse Mortality (NRM)
Patients will be followed-up for survival for 6 months after the first Neihulizumab treatment
Time frame: Day 180
Immunogenicity
Immunogenicity will be monitored by anti-drug antibody (ADA) ELISA
Time frame: Up to Day 56
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Sep 2022, 51 months.
Of 49 phase 1 interventional studies under Graft vs Host Disease, half reached primary completion within 47 months of starting (the median), counting those still running; a quarter within 24 and three quarters within 65. This study's 51 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Neihulizumab
AltruBio Inc.