Bladder CancerPhase 1/2NCT02010203
A Phase 1/2 Study of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer After TURBT
A Phase 1/2 study testing HS-410 and BCG in people with Bladder Cancer, run by Heat Biologics at 19 sites in United States.
Trial summary
Phase I/II study: Phase 1 is an open-label, safety study, patients who previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose intradermal (1*10^6 cells) HS-410 monotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- HS-410 and BCG
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 19 sitesUnited States
- Study dates
- Dec 2013to Apr 2018
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically or cytologically confirmed non-muscle invasive bladder cancer [Ta, T1 or Tis (CIS)] that has been removed by transurethral resection
- Either: (i) high-risk disease, defined as T1 and/or high-grade and/or CIS or (ii) intermediate-risk disease, defined as Ta low-grade with at least 3 of the following 4 risk factors: multiple tumors, tumor size > 3cm, early recurrence (<1 year from previous staging procedure), or recurrence with a frequency of more than once in any 12 month period
- Not have received bacillus Calmette-Guérin (BCG) or have completed previous BCG treatment > 12 months prior to the baseline staging procedure.
- Phase 2 Arms 1-3: Suitable to receive a 6-week course of BCG in the adjuvant setting within 6 weeks following TURBT. Phase 2 Arm 4: Suitable for monotherapy vaccine administration post-TURBT. For Phase 1 only: Has previously received 3-6 weekly doses of BCG.
- Adequate laboratory parameters
Who cannot join
- Human immunodeficiency virus (HIV) infection or immunodeficiency disorders, either primary or acquired
- Infections or intercurrent illness requiring active therapy
- Any condition requiring active steroid or other immunosuppressive therapy
- Active malignancies within the past 12 months except negligible risk of metastasis or death treated with expected curative outcome.
- Prostate pelvic radiation within the past 12 months
- Significant cardiac impairment
Show all 14Show fewer
- Current alcohol or chemical abuse, or mental or psychiatric condition precluding protocol compliance
- Pregnant or nursing
- Allergy to soy, egg, or peanut products
- Receiving another investigational agent (30 day wash-out required prior to first dose)
- Neo-adjuvant therapy prior to baseline staging procedures for the current occurrence of non-muscle invasive bladder cancer
- Prior treatment with a cancer vaccine for this indication
- Prior vaccination with BCG for tuberculosis disease
- Prior splenectomy
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Johns Hopkins University
Baltimore, Maryland, 21287
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27599
University of Chicago
Chicago, Illinois, 60637
Urology of North Texas
Dallas, Texas, 75231
Urology Center of Colorado
Denver, Colorado, 80211
MD Anderson Cancer Center
Houston, Texas, 77030
First Urology
Jeffersonville, Indiana, 47130
Horizon Oncology Research
Lafayette, Indiana, 47905
University of California at Los Angeles
Los Angeles, California, 90095
University of Minnesota
Minneapolis, Minnesota, 55455
Carolina Urologic Research Center
Myrtle Beach, South Carolina, 29572
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Skyline Urology
Sherman Oaks, California, 91411
Washington University School of Medicine
St Louis, Missouri, 63110
Montefiore Medical Center
The Bronx, New York, 10471
Skyline Urology
Torrance, California, 90505
Urology of Virginia
Virginia Beach, Virginia, 23462
University of Kansas Cancer Center
Westwood, Kansas, 66205
University of Massachusetts
Worcester, Massachusetts, 01655
About this study
Official title: Phase 1/2, Placebo-Controlled, Randomized Study to Evaluate the Safety, Immune Response & Clinical Activity of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer Who Have Undergone Transurethral Resection of Bladder Tumor (TURBT)
Phase I/II study: Phase 1 is an open-label, safety study, patients who previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose intradermal (1*10^6 cells) HS-410 monotherapy. Phase 2, patients will be randomized to one of three blinded (physician-patient), placebo-controlled groups and receive either intradermal placebo or low dose (1*10^6 cells) or high dose (1*10^7 cells) vesigenurtacel-L in combination with induction and maintenance intravesical BCG. Patients who do not receive BCG will be enrolled into an open-label, non-randomized group receiving high dose (1*10^7 cells) intradermal HS-410 monotherapy.
Read the detailed description
This study is a two part study: Phase I and Phase II. The Phase 1 portion is an open-label, safety study. Patients will have previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose intradermal (1*10^6 cells) HS-410 monotherapy. In Phase 2, patients will be assigned to treatment groups based on whether they will receive induction BCG in the typical post-TURBT window. If the investigator plans to administer BCG, patients will be randomized to one of three blinded (physician-patient), placebo-controlled groups and receive either intradermal placebo or low dose (1*10^6 cells) or high dose (1*10^7 cells) vesigenurtacel-L in combination with induction and maintenance intravesical BCG. If patients will not receive BCG, they will be enrolled into an open-label, non-randomized group and receive high dose (1*10^7 cells) intradermal HS-410 monotherapy.
- Conditions
- Bladder Cancer
- Being tested
- HS-410, Placebo, BCG
- Keywords
- TURBT, Bladder, Cancer, GP96, Vaccine, Immunotherapy, Heat Biologics, BCG, Bacillus Calmette-Guerin, Bacillus Calmette-Guérin
- Medical subject headings
- Urinary Bladder Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS-410Biological
Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
PlaceboBiological
Injection containing sterile solution but no cells
BCGBiological
Also called Bacillus Calmette-Guerin
Vaccine derived from a live bacterium
| Study group | Role | What they receive |
|---|---|---|
| Phase I: HS-410 Low Dose | Experimental | In the open label Phase 1 portion, HS-410 is given as 1*10^6 cells per dose for 12 weekly injections followed by 3 monthly injections. Receives: Biological: HS-410 |
| Phase II: HS-410 Low-Dose Plus BCG | Experimental | In the Phase 2 portion, HS-410 is given as 1*10^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG. Receives: Biological: HS-410; Biological: BCG |
| Phase II: High-Dose HS-410 Plus BCG | Experimental | In the Phase 2 portion, HS-410 is given as 1*10^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG. Receives: Biological: HS-410; Biological: BCG |
| Phase II: Placebo Plus BCG | Placebo comparator | In the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG. Receives: Biological: Placebo; Biological: BCG |
| Phase II: High-Dose HS-410 | Experimental | In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. Receives: Biological: HS-410 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 1: Safety and Tolerability
To evaluate the safety and tolerability of vesigenurtacel-L
Measured: Up to 3 years.
Phase 2: 1-year Disease-Free Survival
Arm 1, 2, 3: 1-year DFS in patients with NMIBC treated with BCG in combination with blinded study product (one of two doses of vesigenurtacel-L or placebo) Arm 4: 1-year DFS in patients with NMIBC treat1fv 9 with high dose vesigenurtacel-L monotherapy
One-year disease-free survival will be defined as the proportion of patients who are free from recurrent disease, progressive disease, and alive one year after the date of randomization/treatment assignment
Measured: One year
Secondary outcomes (15)
Proportion of Patients With Recurrence at 3, 6, 12, 18, and 24 Months
Evaluate the proportion of patients with recurrence at 3, 6, 12, 18, and 24 months
Measured: Up to 2 years
Proportion of Patients With Progressive Disease at 3, 6, 12, 18, and 24 Months
Evaluate the proportion of patients with progressive disease at 3, 6, 12, 18, and 24
Measured: Up to 2 years
Disease-free Survival at 3, 6, 18, and 24 Months
Evaluate Disease Free Survival at 3, 6, 18 and 24 months
Measured: Up to 2 years
Overall Disease-free Survival
Evaluate overall Disease Free Survival
Measured: Up to 3 years
Overall Survival, Expressed as the Number of Participants Alive
Evaluate overall survival (OS)
Measured: Up to 3 years
Proportion of Patients Undergoing Repeat Transurethral Resection of Bladder Tumor (TURBT) by 12 and 24 Months
Measured: Up to 2 years
Proportion of Patients Undergoing Cystectomy by 12 and 24 Months
Evaluate the proportion of patients undergoing cystectomy by 12 and 24 months from randomization
Measured: Up to 2 years
Immunologic Response of PBMCs Via Intracellular Cytokine Staining (ICS) by Flow Cytometry and/or Enzyme-linked Immunosorbent Spot (ELISPOT) on CD8+ Cells After HS-410 Vaccination as Compared to Baseline.
Evaluate the proportion of patients with immunologic response of peripheral blood mononuclear cells (PBMCs) via intracellular cytokine staining (ICS) by flow cytometry and/or ELISPOT on CD8+ cells following vesigenurtacel-L vaccination
Measured: Up to 2 years
Immunologic Response of Peripheral Blood Mononuclear Cells (PBMCs) and Stimulation Analysis Via ICS in Baseline and Post-treatment Biopsies, if Clinically Indicated
Evaluate immunologic response of PBMCs (analysis of surface markers, CD3, CD4, CD8, CD19, CD25, CD45, CD56, FoxP3, and degranulation) and stimulation analysis via ICS of interferon gamma (IFNγ) and granzyme B (gzB)
Measured: Up to 3 years
Total PBMC Counts by Flow Cytometry
Evaluate total PBMC counts by flow cytometry, including lymphocyte subsets (B cells, helper T-cells, cytotoxic T-cells, natural killer (NK) cells and T-reg)
Measured: Up to 3 years
Tumor Antigen Expression
Evaluation of pre-treatment tumor tissue for antigen expression
Measured: At screening
Tumor Infiltrating Lymphocytes (TILs)
Evaluation of tumor tissue obtained from repeat biopsy, if clinically indicated, for presence of TILs
Measured: Up to 3 years
T Cell Receptor Sequencing of Peripheral Blood T Cells Before and During Treatment
Evaluation of tumor tissue obtained from repeat biopsy, if clinically indicated, for presence of TILs, T cell receptor sequencing of peripheral blood T cells before and during the course of treatment.
Measured: Up to 2 years
Safety of the Combination of the HS-410 and BCG
Phase 2 only Evaluate the safety of the combination of vesigenurtacel-L and BCG
Measured: Up to 1 year
Safety of the High Dose HS-410 Monotherapy
Phase 2 only Evaluate the safety of high dose vesigenurtacel-L monotherapy
Measured: Up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2017
- Study completionApr 2018
Why it stopped: Inability to accrue due to changing treatment landscape (PD-1 approvals)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bladder CancerStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heat Biologics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gary Steinberg, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010203
- Sponsor's protocol ID
- HS410-101
- Status last verified
- Feb 2020
- First submitted
- 5 Dec 2013
- Last updated
- 17 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1/2, Placebo-Controlled, Randomized Study to Evaluate the Safety, Immune Response & Clinical Activity of HS-410 in Patients With Non-Muscle Invasive Bladder Cancer Who Have Undergone Transurethral Resection of Bladder Tumor (TURBT)
- ClinicalTrials.gov ID
- NCT02010203
- Acronym / sponsor ID
- HS410-101
- Conditions
- Bladder Cancer
- Keywords
- TURBT, Bladder, Cancer, GP96, Vaccine, Immunotherapy, Heat Biologics, BCG
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to accrue due to changing treatment landscape (PD-1 approvals)
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Heat BiologicsIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2017 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 12 Dec 2013 (estimated)
- Results
- Posted 17 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Phase I/II study: Phase 1 is an open-label, safety study, patients who previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose intradermal (1*10^6 cells) HS-410 monotherapy. Phase 2, patients will be randomized to one of three blinded (physician-patient), placebo-controlled groups and receive either intradermal placebo or low dose (1*10^6 cells) or high dose (1*10^7 cells) vesigenurtacel-L in combination with induction and maintenance intravesical BCG. Patients who do not receive BCG will be enrolled into an open-label, non-randomized group receiving high dose (1*10^7 cells) intradermal HS-410 monotherapy.
Detailed description
This study is a two part study: Phase I and Phase II. The Phase 1 portion is an open-label, safety study. Patients will have previously received 3-6 instillations of weekly intravesical Bacillus Calmette-Guerin (BCG) induction therapy (as standard of care) followed by low dose intradermal (1*10^6 cells) HS-410 monotherapy. In Phase 2, patients will be assigned to treatment groups based on whether they will receive induction BCG in the typical post-TURBT window. If the investigator plans to administer BCG, patients will be randomized to one of three blinded (physician-patient), placebo-controlled groups and receive either intradermal placebo or low dose (1*10^6 cells) or high dose (1*10^7 cells) vesigenurtacel-L in combination with induction and maintenance intravesical BCG. If patients will not receive BCG, they will be enrolled into an open-label, non-randomized group and receive high dose (1*10^7 cells) intradermal HS-410 monotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Phase I: HS-410 Low Dose | Experimental | Biological: HS-410In the open label Phase 1 portion, HS-410 is given as 1*10^6 cells per dose for 12 weekly injections followed by 3 monthly injections. |
| Phase II: HS-410 Low-Dose Plus BCG | Experimental | Biological: HS-410, Biological: BCGIn the Phase 2 portion, HS-410 is given as 1*10^6 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG. |
| Phase II: High-Dose HS-410 Plus BCG | Experimental | Biological: HS-410, Biological: BCGIn the Phase 2 portion, HS-410 is given as 1*10^7 cells per dose weekly for 6 weeks in combination with BCG, followed by 6 weeks of HS-410 alone, and then 3 courses of three once-weekly doses of HS-410 in combination with BCG. |
| Phase II: Placebo Plus BCG | Placebo comparator | Biological: Placebo, Biological: BCGIn the Phase 2 portion, a placebo is given weekly for 6 weeks in combination with BCG, followed by 6 weeks of placebo alone, and then 3 courses of three once-weekly doses of placebo in combination with BCG. |
| Phase II: High-Dose HS-410 | Experimental | Biological: HS-410In the Phase II portion, if patients will not receive BCG, HS-410 is given as 1*10^7 cells per dose weekly for 12 weeks, and then 3 courses of three once-weekly doses of HS-410. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Histologically or cytologically confirmed non-muscle invasive bladder cancer [Ta, T1 or Tis (CIS)] that has been removed by transurethral resection
- Either: (i) high-risk disease, defined as T1 and/or high-grade and/or CIS or (ii) intermediate-risk disease, defined as Ta low-grade with at least 3 of the following 4 risk factors: multiple tumors, tumor size > 3cm, early recurrence (<1 year from previous staging procedure), or recurrence with a frequency of more than once in any 12 month period
- Not have received bacillus Calmette-Guérin (BCG) or have completed previous BCG treatment > 12 months prior to the baseline staging procedure.
- Phase 2 Arms 1-3: Suitable to receive a 6-week course of BCG in the adjuvant setting within 6 weeks following TURBT. Phase 2 Arm 4: Suitable for monotherapy vaccine administration post-TURBT. For Phase 1 only: Has previously received 3-6 weekly doses of BCG.
- Adequate laboratory parameters
Key exclusion criteria (14 listed)
- Human immunodeficiency virus (HIV) infection or immunodeficiency disorders, either primary or acquired
- Infections or intercurrent illness requiring active therapy
- Any condition requiring active steroid or other immunosuppressive therapy
- Active malignancies within the past 12 months except negligible risk of metastasis or death treated with expected curative outcome.
- Prostate pelvic radiation within the past 12 months
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 |
|---|---|---|
| HS-410Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96 | Biological | Phase I: HS-410 Low Dose, Phase II: HS-410 Low-Dose Plus BCG, Phase II: High-Dose HS-410, Phase II: High-Dose HS-410 Plus BCG |
| PlaceboInjection containing sterile solution but no cells | Biological | Phase II: Placebo Plus BCG |
| BCGAlso: Bacillus Calmette-GuerinVaccine derived from a live bacterium | Biological | Phase II: HS-410 Low-Dose Plus BCG, Phase II: High-Dose HS-410 Plus BCG, Phase II: Placebo Plus BCG |
Primary outcome
Phase 1: Safety and Tolerability
Time frame: Up to 3 years.
To evaluate the safety and tolerability of vesigenurtacel-L
Phase 2: 1-year Disease-Free Survival
Time frame: One year
Arm 1, 2, 3: 1-year DFS in patients with NMIBC treated with BCG in combination with blinded study product (one of two doses of vesigenurtacel-L or placebo) Arm 4: 1-year DFS in patients with NMIBC treat1fv 9 with high dose vesigenurtacel-L monotherapy One-year disease-free survival will be defined as the proportion of patients who are free from recurrent disease, progressive disease, and alive one year after the date of randomization/treatment assignment
15 secondary outcomes
Proportion of Patients With Recurrence at 3, 6, 12, 18, and 24 Months
Time frame: Up to 2 years
Proportion of Patients With Progressive Disease at 3, 6, 12, 18, and 24 Months
Time frame: Up to 2 years
Disease-free Survival at 3, 6, 18, and 24 Months
Time frame: Up to 2 years
Overall Disease-free Survival
Time frame: Up to 3 years
Overall Survival, Expressed as the Number of Participants Alive
Time frame: Up to 3 years
Proportion of Patients Undergoing Repeat Transurethral Resection of Bladder Tumor (TURBT) by 12 and 24 Months
Time frame: Up to 2 years
Proportion of Patients Undergoing Cystectomy by 12 and 24 Months
Time frame: Up to 2 years
Immunologic Response of PBMCs Via Intracellular Cytokine Staining (ICS) by Flow Cytometry and/or Enzyme-linked Immunosorbent Spot (ELISPOT) on CD8+ Cells After HS-410 Vaccination as Compared to Baseline.
Time frame: Up to 2 years
Immunologic Response of Peripheral Blood Mononuclear Cells (PBMCs) and Stimulation Analysis Via ICS in Baseline and Post-treatment Biopsies, if Clinically Indicated
Time frame: Up to 3 years
Total PBMC Counts by Flow Cytometry
Time frame: Up to 3 years
Tumor Antigen Expression
Time frame: At screening
Tumor Infiltrating Lymphocytes (TILs)
Time frame: Up to 3 years
T Cell Receptor Sequencing of Peripheral Blood T Cells Before and During Treatment
Time frame: Up to 2 years
Safety of the Combination of the HS-410 and BCG
Time frame: Up to 1 year
Safety of the High Dose HS-410 Monotherapy
Time frame: Up to 3 years.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Gary Steinberg, MD principal investigator
University of Chicago
19 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 HS-410 and BCG in people with Bladder Cancer, run by Heat Biologics at 19 sites in United States.
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 5 inclusion and 14 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 17 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 17 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Phase 1: Safety and Tolerability (time frame: Up to 3 years.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2020.