Glioblastoma MultiformePhase 1/2TEM-GBMNCT03866109
A Study Evaluating Temferon in Patients With Glioblastoma & Unmethylated MGMT
A Phase 1/2 study testing Temferon in people with Glioblastoma Multiforme, run by Genenta Science at 3 sites in Italy.
Trial summary
This is a non-randomized, open label, phase I/IIa, dose-escalation study, involving a single injection of Temferon, an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor cells exposed to transduction with a lentiviral vector driving myeloid specific… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Glioblastoma Multiforme
- What is being tested?
- Temferon
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesItaly
- Study dates
- 5 Mar 2019to 27 May 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed, newly diagnosed supratentorial glioblastoma with unmethylated MGMT gene promoter.
- Patients have undergone complete or partial tumor resection.
- Able and willing to provide written informed consent and comply with the study protocol and procedures.
- Eligible for radiotherapy.
- Life expectancy of 6 months or more at Screening.
- Women of child-bearing potential enrolled in the study must have a negative pregnancy test at screening and agree to use acceptable methods of contraception during the trial.
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- Men enrolled in the study with partners who are women of child-bearing potential, must be willing to use an acceptable barrier contraceptive method during the trial or have undergone successful vasectomy at least 6 months prior to entry into the study. Successful vasectomy needs to have been confirmed by semen analysis.
- Karnofsky performance score (KPS)≥70.
- Additional inclusion criteria to be assessed within 20 days of Temferon administration:
- Adequate cardiac, renal, hepatic and pulmonary function as evidenced by:
- Left ventricular ejection fraction (LVEF) ≥ 45% by echo and normal electrocardiogram (ECG) or presence of abnormalities not significant for cardiac disease.
- Absence of severe pulmonary hypertension;
- Diffusing capacity of the lung for carbon monoxide (DLCO) >50% and forced expiratory volume in 1 sec (FEV1) and forced expiratory vital capacity (FVC) > 60% predicted (if non cooperative: pulse oximetry > 95% in room air);
- Serum creatinine < 2x upper limit normal and estimated glomerular filtration rate (eGFR) ≥ 30ml/min/1.73m^2;
- Alkaline phosphatase (ALP), alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal (ULN), and total bilirubin ≤ 2.0 mg/dl.
- Hemoglobin ≥10 g/dL, platelet count ≥100000/mm^3, absolute neutrophil count >1500/mm^3.
Who cannot join
- Use of other investigational agents or procedures within 4 weeks prior to study enrolment (within 6 weeks if use of long-acting agents) or participation in a previous gene therapy study.
- Known hypersensitivity to carmustine (or any other nitrosurea), busulfan, thiotepa, lenograstim, plerixafor, or any excipients used in these products.
- Receipt of any oral or parenteral chemotherapy or immunotherapy within 2 years of Screening.
- Previous allogeneic bone marrow transplantation, kidney or liver transplant.
- Clinical evidence of persistent raised intracranial pressure following surgical resection.
- Clinically relevant active viral, bacterial, or fungal infection at eligibility evaluation.
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- Active autoimmune disease or a relevant history of important autoimmune manifestations, in particular psoriasis, systemic lupus erythematosus (SLE), rheumatoid arthritis, vasculitis, immunemediated peripheral neuropathies.
- History of sarcoidosis.
- History or current evidence of neuropsychiatric illness including depression, schizophrenia, bipolar disorders, impaired cognitive function, dementia or suicidal tendency.
- History of severe cardiovascular disease such as prior stroke, coronary artery disease requiring intervention or unresolved arrhythmias in the past 6 months.
- Evidence of any hematological neoplasm.
- Positivity for human immunodeficiency virus type 1 or 2 (HIV-1, HIV-2) (serology or RNA), and/or Hepatitis B Virus Surface Antigen (HbsAg) and/or Hepatitis B Virus (HBV) DNA and/or Hepatitis C virus (HCV) RNA (or negative HCV RNA but on antiviral treatment) and/or Treponema Pallidum or Mycoplasma active infection.
- Active alcohol or substance abuse within 6 months of the study.
- Current pregnancy or lactation.
- Known bleeding diathesis or history of abnormal bleeding, or any other known coagulation abnormalities that would contraindicate lumbar puncture for CSF or future surgery.
- Use of immunosuppressants with the exception of steroids. The maximum permitted dexamethasone (or equivalent) dose is 4 mg per day.
Trial locations and contacts
3 sites in 1 country.
Italy3 sites
Ospedale San Raffaele
Milan, 20132
Fondazione IRCCS Istituto Neurologico "Carlo Besta"
Milan, 20133
Policlinico Universitario Fondazione Agostino Gemelli
Rome
About this study
Official title: A Phase I/IIa Dose Escalation Study Evaluating the Safety and Efficacy of Autologous CD34+-Enriched HSPCs Genetically Modified With Human Interferon-α2 in Patients With Glioblastoma Multiforme and Unmethylated MGMT Gene Promoter
This is a non-randomized, open label, phase I/IIa, dose-escalation study, involving a single injection of Temferon, an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor cells exposed to transduction with a lentiviral vector driving myeloid specific interferon-alpha2 expression, which will be administered to up to 27 patients affected by GBM who have an unmethylated MGMT promoter. Part A will evaluate the safety and tolerability of 5 escalating doses of Temferon and 3 different conditioning regimens in up to 27 patients, following first line treatment.
Read the detailed description
This is a non-randomized, open label, multicenter, phase I/IIa, therapeutic-exploratory, dose escalation, prospective study, involving a single injection of Temferon, an investigational ATMP consisting of autologous CD34+-enriched HSPCs exposed to transduction with a 3rd generation lentiviral vector driving myeloid-specific IFN-alpha2 expression, which will be administered to up to 27 patients affected by GBM who have an unmethylated MGMT promoter. The study will recruit and follow-up patients at a specialist neurosurgical and neuro-oncology units in Italy. Administration of Temferon and hematological follow up will take place at specialist hematology and bone marrow transplantation units.
Potentially eligible patients will be identified immediately after surgical resection of GBM once the MGMT promoter methylator status is known. Once written, informed consent is obtained, and screening procedures have been completed, harvesting of HSPCs will occur. A standard of care regimen lasting approximately 6 weeks, will then take place . During this time, Temferon manufacturing will occur. Following completion of radiotherapy, patients will be admitted for receipt of a conditioning regimen consisting of BCNU and thiotepa (Cohorts 1-6), busulfan and thiotepa (Cohort 5), or busulfan (Cohorts 7 and 8). This will be followed by administration of Temferon. In-patient monitoring will occur until hematological recovery occurs. Thereafter, regular follow-up of patients will occur up to 2 years (+720 days) with the majority of assessments and procedures. At the +720 day visit, patients will be invited to participate in a long term follow-up study which will last for an additional 6 years.
In Part A of the study, 8 cohorts of 3 patients will receive 5 escalating doses of Temferon. On completion of dose escalation in Part A, a conditioning regimen and single dose of Temferon will be selected to be studied in up to a further 6 patients.
In the event that GBM disease progression occurs, patients will be managed with second line therapies including second surgery, TMZ, BCNU, fotemustine or any other approved therapy for GBM.
- Conditions
- Glioblastoma Multiforme
- Being tested
- Temferon
- Keywords
- Temferon, Gene Therapy, Immunotherapy, Solid tumor
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TemferonDrug
Genetically modified HSPCs
| Study group | Role | What they receive |
|---|---|---|
| Temferon | Experimental | Autologous CD34+-enriched hematopoietic progenitor cells exposed in vitro to specific lentiviral vector encoding for the human interferon-alpha 2 gene. Its expression is tightly controlled by the human TIE2 enhancer/promoter sequence and by a post-transcriptional regulation layer represented by target miRNA sequences. This enables suppression of interferon-alpha2 expression in HSPCs, thereby further increasing the specificity of the delivery strategy for their Tie2 expressing myeloid cell progeny. Receives: Drug: Temferon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability and safety of Temferon over the first 90 days following administration as determined by the incidence of adverse events
Routine clinical and laboratory surveillance
Measured: 90 days
Secondary outcomes (13)
Long term tolerability and safety of Temferon as determined by the incidence of adverse events
Routine clinical and laboratory surveillance
Measured: 2 years
Proportion of patients achieving haematologic recovery by Day +30 (defined as the first of at least 3 consecutive days with a neutrophil count >0.5 x 10^9/L and platelet count >20 x 10^9/L)
Hematologic recovery is defined as the first of at least 3 consecutive days with a neutrophil count >0.5 x 10^9/L and platelet count >20 x 10^9/L.
Measured: 30 days
Determine the maximum tolerated dose of Temferon
Presence of a CTCAE Grade 3-5 adverse event (AE) that occurs within the first 30 days and is attributed to Temferon.
Measured: 30 days
Identify presence of transduced myeloid cells in bone marrow as determined by vector copy number
VCN
Measured: Over 2 years
Incidence of adverse events attributed to the conditioning regimen
Adverse events for BCNU and thiotepa, busulfan and thiotepa, or busulfan monotherapy up to Day +45
Measured: Day +30
Identify presence of transduced myeloid cells in peripheral blood as determined by vector copy number
VCN
Measured: Over 2 years
Determine clinical response in patients as determined by iRANO criteria
iRANO criteria
Measured: Over 2 years
Determine progression free survival in patients
MRI
Measured: Over 2 years
Determine overall survival in patients
Survival data
Measured: 2 years
Changes in functional status (Eastern Cooperative Oncology Group)
ECOG assessment:
0 Fully active, able to carry on all pre-disease performance without restriction
- Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
- Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
- Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
- Dead
Measured: 2 years
Changes in functional status (Karnofsky)
Karnofsky assessment
Measured: 2 years
Changes in Quality of Life (European Organisation for Research and Treatment of Cancer EORTC C30)
EORTC C30 questionnaire
Measured: 2 years
Changes in Quality of Life (BN20)
European Organisation for Research and Treatment of Cancer BN20 questionnaire
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start5 Mar 2019
- Primary completion27 May 2026
- Study completion27 May 2026
Why it stopped: LVLP (pt GBM-01034) took place on 27may2026. The 2 remaining slots allocated by the protocol for the additional cohort to generate safety data prior to study Part B will not be filled. No safety concerns. Benefit-risk profile unchanged.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma MultiformeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- 8 cohorts: Cohorts 1-4, 6: Thiotepa and BCNU Conditioning; Temferon dose 0.5 - 3 x10\^6 CD34+ cells/kg; Cohort 5: Thiotepa and Busulfan Condtioning; Temferon 2 x 10\^6 CD34+ cells/kg; Cohort 7: Busulfan conditioning; Temferon 3 x 10\^6 CD34+ cells/kg; Cohort 8: Busulfan conditioning; Temferon 4 x 10\^6 CD34+ cells/kg;
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genenta Science
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gaetano Finocchiaro, MD, Study chair, Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03866109
- Sponsor's protocol ID
- TEM-GBM_001
- Other IDs
- 2018-001404-11, 2023-510299-29, 2023, 2018
- Acronym
- TEM-GBM
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2019
- Last updated
- 11 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gentner B, Eoli M, Farina F, Barcella M, Capotondo A, Mazzoleni S, Brambilla V, Francavilla A, Garramone M, Carrabba MG, Ferla V, Bruno A, Alvisi G, Coltella N, Montini E, Hadadi L, Capt C, Cuccarini V, Bruzzone MG, Di Meco F, Legnani FG, Ferroli P, Acerbi F, Pallini R, D'Alessandris QG, Olivi A, Gagliardi F, Snider S, Mortini P, Patane M, Fiocchi A, Berno V, Poliani PL, Finocchiaro G, Russo C, Ciceri F, Naldini L. Tumor-targeted interferon-alpha gene therapy for glioblastoma: a phase 1 trial. Nat Med. 2026 Jun;32(6):2216-2226. doi: 10.1038/s41591-026-04419-1. Epub 2026 Jun 1.
PubMed 42225991
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Dose Escalation Study Evaluating the Safety and Efficacy of Autologous CD34+-Enriched HSPCs Genetically Modified With Human Interferon-α2 in Patients With Glioblastoma Multiforme and Unmethylated MGMT Gene Promoter
- ClinicalTrials.gov ID
- NCT03866109
- Acronym / sponsor ID
- TEM-GBM / TEM-GBM_001
- Conditions
- Glioblastoma Multiforme
- Keywords
- Temferon, Gene Therapy, Immunotherapy, Solid tumor
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: LVLP (pt GBM-01034) took place on 27may2026. The 2 remaining slots allocated by the protocol for the additional cohort to generate safety data prior to study Part B will not be filled. No safety concerns. Benefit-risk profile unchanged.
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Genenta ScienceIndustry (pharma, biotech, devices)
- Study start
- 5 Mar 2019 (actual)
- Primary completion
- 27 May 2026 (actual)
- Study completion
- 27 May 2026 (actual)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a non-randomized, open label, phase I/IIa, dose-escalation study, involving a single injection of Temferon, an investigational advanced therapy consisting of autologous CD34+-enriched hematopoietic stem and progenitor cells exposed to transduction with a lentiviral vector driving myeloid specific interferon-alpha2 expression, which will be administered to up to 27 patients affected by GBM who have an unmethylated MGMT promoter. Part A will evaluate the safety and tolerability of 5 escalating doses of Temferon and 3 different conditioning regimens in up to 27 patients, following first line treatment.
Detailed description
This is a non-randomized, open label, multicenter, phase I/IIa, therapeutic-exploratory, dose escalation, prospective study, involving a single injection of Temferon, an investigational ATMP consisting of autologous CD34+-enriched HSPCs exposed to transduction with a 3rd generation lentiviral vector driving myeloid-specific IFN-alpha2 expression, which will be administered to up to 27 patients affected by GBM who have an unmethylated MGMT promoter. The study will recruit and follow-up patients at a specialist neurosurgical and neuro-oncology units in Italy. Administration of Temferon and hematological follow up will take place at specialist hematology and bone marrow transplantation units.
Potentially eligible patients will be identified immediately after surgical resection of GBM once the MGMT promoter methylator status is known. Once written, informed consent is obtained, and screening procedures have been completed, harvesting of HSPCs will occur. A standard of care regimen lasting approximately 6 weeks, will then take place . During this time, Temferon manufacturing will occur. Following completion of radiotherapy, patients will be admitted for receipt of a conditioning regimen consisting of BCNU and thiotepa (Cohorts 1-6), busulfan and thiotepa (Cohort 5), or busulfan (Cohorts 7 and 8). This will be followed by administration of Temferon. In-patient monitoring will occur until hematological recovery occurs. Thereafter, regular follow-up of patients will occur up to 2 years (+720 days) with the majority of assessments and procedures. At the +720 day visit, patients will be invited to participate in a long term follow-up study which will last for an additional 6 years.
In Part A of the study, 8 cohorts of 3 patients will receive 5 escalating doses of Temferon. On completion of dose escalation in Part A, a conditioning regimen and single dose of Temferon will be selected to be studied in up to a further 6 patients.
In the event that GBM disease progression occurs, patients will be managed with second line therapies including second surgery, TMZ, BCNU, fotemustine or any other approved therapy for GBM.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 8 cohorts: Cohorts 1-4, 6: Thiotepa and BCNU Conditioning; Temferon dose 0.5 - 3 x10^6 CD34+ cells/kg; Cohort 5: Thiotepa and Busulfan Condtioning; Temferon 2 x 10^6 CD34+ cells/kg; Cohort 7: Busulfan conditioning; Temferon 3 x 10^6 CD34+ cells/kg; Cohort 8: Busulfan conditioning; Temferon 4 x 10^6 CD34+ cells/kg;
| Arm | Type | Receives |
|---|---|---|
| Temferon | Experimental | Drug: TemferonAutologous CD34+-enriched hematopoietic progenitor cells exposed in vitro to specific lentiviral vector encoding for the human interferon-alpha 2 gene. Its expression is tightly controlled by the human TIE2 enhancer/promoter sequence and by a post-transcriptional regulation layer represented by target miRNA sequences. This enables suppression of interferon-alpha2 expression in HSPCs, thereby further increasing the specificity of the delivery strategy for their Tie2 expressing myeloid cell progeny. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Histologically confirmed, newly diagnosed supratentorial glioblastoma with unmethylated MGMT gene promoter.
- Patients have undergone complete or partial tumor resection.
- Able and willing to provide written informed consent and comply with the study protocol and procedures.
- Eligible for radiotherapy.
- Life expectancy of 6 months or more at Screening.
Key exclusion criteria (16 listed)
- Use of other investigational agents or procedures within 4 weeks prior to study enrolment (within 6 weeks if use of long-acting agents) or participation in a previous gene therapy study.
- Known hypersensitivity to carmustine (or any other nitrosurea), busulfan, thiotepa, lenograstim, plerixafor, or any excipients used in these products.
- Receipt of any oral or parenteral chemotherapy or immunotherapy within 2 years of Screening.
- Previous allogeneic bone marrow transplantation, kidney or liver transplant.
- Clinical evidence of persistent raised intracranial pressure following surgical resection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TemferonGenetically modified HSPCs | Drug | Temferon |
Primary outcome
Tolerability and safety of Temferon over the first 90 days following administration as determined by the incidence of adverse events
Time frame: 90 days
Routine clinical and laboratory surveillance
13 secondary outcomes
Long term tolerability and safety of Temferon as determined by the incidence of adverse events
Time frame: 2 years
Proportion of patients achieving haematologic recovery by Day +30 (defined as the first of at least 3 consecutive days with a neutrophil count >0.5 x 10^9/L and platelet count >20 x 10^9/L)
Time frame: 30 days
Determine the maximum tolerated dose of Temferon
Time frame: 30 days
Identify presence of transduced myeloid cells in bone marrow as determined by vector copy number
Time frame: Over 2 years
Incidence of adverse events attributed to the conditioning regimen
Time frame: Day +30
Identify presence of transduced myeloid cells in peripheral blood as determined by vector copy number
Time frame: Over 2 years
Determine clinical response in patients as determined by iRANO criteria
Time frame: Over 2 years
Determine progression free survival in patients
Time frame: Over 2 years
Determine overall survival in patients
Time frame: 2 years
Changes in functional status (Eastern Cooperative Oncology Group)
Time frame: 2 years
Changes in functional status (Karnofsky)
Time frame: 2 years
Changes in Quality of Life (European Organisation for Research and Treatment of Cancer EORTC C30)
Time frame: 2 years
Changes in Quality of Life (BN20)
Time frame: 2 years
Results and safety
The study was stopped early (reason given: LVLP (pt GBM-01034) took place on 27may2026. The 2 remaining slots allocated by the protocol for the additional cohort to generate safety data prior to study Part B will not be filled. No safety concerns. Benefit-risk profile unchanged.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Derived from this study: PubMed 42225991Gentner B, Eoli M, Farina F, Barcella M, Capotondo A, Mazzoleni S, Brambilla V, Francavilla A, Garramone M, Carrabba MG, Ferla V, Bruno A, Alvisi G, Coltella N, Montini E, Hadadi L, Capt C, Cuccarini V, Bruzzone MG, Di Meco F, Legnani FG, Ferroli P, Acerbi F, Pallini R, D'Alessandris QG, Olivi A, Gagliardi F, Snider S, Mortini P, Patane M, Fiocchi A, Berno V, Poliani PL, Finocchiaro G, Russo C, Ciceri F, Naldini L. Tumor-targeted interferon-alpha gene therapy for glioblastoma: a phase 1 trial. Nat Med. 2026 Jun;32(6):2216-2226. doi: 10.1038/s41591-026-04419-1. Epub 2026 Jun 1.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gaetano Finocchiaro, MD study chair
Ospedale San Raffaele
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Temferon in people with Glioblastoma Multiforme, run by Genenta Science at 3 sites in Italy.
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 16 inclusion and 16 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 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Italy. 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?
The study was stopped early (reason given: LVLP (pt GBM-01034) took place on 27may2026. The 2 remaining slots allocated by the protocol for the additional cohort to generate safety data prior to study Part B will not be filled. No safety concerns. Benefit-risk profile unchanged.). Results are not available in the source record.
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?
Tolerability and safety of Temferon over the first 90 days following administration as determined by the incidence of adverse events (time frame: 90 days). 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 NCT03866109, 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 11 Jun 2026.