AMLPhase 1NCT05473910
A Study of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA)
A Phase 1 study testing SOC + TSC-101 and SOC + TSC-100 in people with AML and MDS, run by TScan Therapeutics, Inc. at 21 sites in United States.
Trial summary
This is a multi-center, non-randomized, concurrent controlled, multi-arm, Phase 1 interventional, open-label, biologic assignment-based umbrella study evaluating the feasibility, safety and preliminary efficacy of an escalating dose regimen of up to 2 doses of TSC-100 and TSC-101 in patients with AML, MDS, or ALL… Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- SOC + TSC-101 and SOC + TSC-100
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 21 sitesUnited States
- Study dates
- 1 Nov 2022to Jun 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Male or female aged ≥ 18 years at the time of signing the informed consent.
- Eastern Cooperative Oncology Group (ECOG)-PS ≤ 2 at the time of the screening visit.
- Contraceptive use by male and female participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male Participants:
- A male participant must agree to use a highly effective contraceptive as detailed in Appendix 4 of this protocol during the intervention period and for at least 12 months after the last dose of study intervention and refrain from donating sperm during this period.
- Female Participants:
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- A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) OR
- A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 12 months after the last dose of study intervention.
- Preparing to undergo allogeneic HCT for either of the following:
- AML, MDS, ALL
- Participants in the treatment arms must express HLA-A*0201. Participants in the control arm may express any HLA type.
- Having the HA1+/- or HA-1+/+ (HA-1 positive) genotype to be eligible for TSC-100 treatment.
- Having the HA2+/- HA-2+/+ (HA-2 positive) genotype to be eligible for TSC-101 treatment.
- Having a haploidentical donor, MMUD, or MUD for HCT who is adequately HLA-matched by institutional standards and meets the donor inclusion criteria.
- Considered to be clinically indicated for haploidentical donor, MMUD, or MUD transplantation at the discretion of the treating investigator.
- Considered to be clinically indicated for RIC at the discretion of the treating investigator.
- Considered to be clinically indicated for peripheral blood stem cell transplantation at the discretion of the treating investigator.
- Organ function parameters for transplant eligibility are met per institutional standards.
- Capable of giving signed informed consent - which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Participants must provide consent for mandatory study procedures including bone marrow biopsy and blood sampling for research analyses in the ICF.
- Participants must agree to participate in long-term follow-up for up to 15 years post initial product treatment if they are enrolled in the study and receive the investigational Tcell infusion.
- Donor Inclusion Criteria :
- Male or female aged ≥ 18 years at the time of signing the informed consent. Able to undergo peripheral blood stem cell (PBSC) collection and up to 2 rounds of leukapheresis (for TSC-100 or TSC101 manufacturing for treatment arms only, and f for stem cell collection for both treatment arms and the control arm).
- Donors matched to TSC-100 participants should be HA-1-/- (negative) and/or negative for all HLA-A02 alleles Donors matched to TSC-101 participants should be negative for all HLA-A02 alleles Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Who cannot join
- Medical or psychological conditions that would make the participant an unsuitable candidate for cell therapy including another concurrent uncontrolled malignancy or active CNS disease.
- The presence of organ toxicities will not necessarily exclude participants from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA1/HA2 TCRT cells may be required at the discretion of the treating investigator Participants with levels of donor-specific HLA antibodies that are considered by the treating investigator to be high enough to warrant desensitization protocols and who have no alternate donors.
- Participants who meet inclusion criteria for TSC-101 but who are also positive for HLAA02:07.
- Participants with evidence of clinically significant infection or uncontrolled viral r reactivation of cytomegalovirus (CMV), Epstein-Barr virus (EBV), Adenovirus, BK virus (BKV), or human herpesvirus 6 (HHV-6).
- Participants with active cardiac disease, defined as:
- Uncontrolled or symptomatic angina within the past 3 months. History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes). Atrial fibrillation with controlled ventricular response on treatment is not an exclusion.
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- Myocardial infarction < 3 months from study entry. Uncontrolled or symptomatic congestive heart failure. Prior allogeneic HCT. Participants who have a history of hypersensitivity to murine proteins. Enrollment on a concomitant trial with a novel investigational agent. Use of anti-thymocyte globulin, alemtuzumab, or other in vivo T-cell depleting agents from Day -14 through end of study.
- Donor Exclusion Criteria :
- Donors for TSC-100 positive for any HLA-A02 allele would be excluded unless they are HA-1 negative. If donors with any HLA-A02 allele are considered for patients eligible for TSC-100, the donor would undergo HA-1 testing to ensure that the donor is HA-1 negative (40% probability).
- Donors for TSC-101 positive for any HLA-A02 allele are excluded regardless of HA- 2 status.
- Donors who test positive for any of the following: HIV-1, HIV-2, human T-lymphotropic virus (HTLV)-1, HTLV-2 seropositive or with active hepatitis B or hepatitis C virus infection, syphilis, West Nile virus through central lab testing. Donors who screen positive for risk of CreutzfeldtJakob disease or Zika virus infection using donor history questionnaires will also be excluded. Donors with evidence of past CMV or EBV infections will be allowed.
- Related donor residing outside of the United States of America (USA). If the donor screening, testing and leukapheresis can be performed at the same site where the participant is being treated, the donor is considered eligible.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Northside Hospital
Atlanta, Georgia, 30342
University of Colorado - Anschutz Cancer Center
Aurora, Colorado, 80045
St. David's South Austin Medical Center
Austin, Texas, 76704
Johns Hopkins University
Baltimore, Maryland, 21287
Mass General Hospital
Boston, Massachusetts, 02114
Dana-Farber Cancer Institute - Hematology/Oncology
Boston, Massachusetts, 02215
University North Carolina
Chapel Hill, North Carolina, 27599
Baylor University Medical Center
Dallas, Texas, 75246
SCRI - Colorado Blood Cancer Institute
Denver, Colorado, 80218
Karmanos Cancer Institute
Detroit, Michigan, 48201
City of Hope
Duarte, California, 91010
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Memorial Cancer Institute
Hollywood, Florida, 33021
MD Anderson
Houston, Texas, 77030
Froedert and Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
SCRI - TriStar Bone Marrow Transplant
Nashville, Tennessee, 37203
Yale
New Haven, Connecticut, 06510
Columbia University
New York, New York, 10027
Mount Sinai
New York, New York, 10029-6696
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Moffitt Cancer Institute
Tampa, Florida, 33612
About this study
Official title: A Phase 1/3 Study Evaluating the Efficacy and Safety of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA-2)
This is a multi-center, non-randomized, concurrent controlled, multi-arm, Phase 1 interventional, open-label, biologic assignment-based umbrella study evaluating the feasibility, safety and preliminary efficacy of an escalating dose regimen of up to 2 doses of TSC-100 and TSC-101 in patients with AML, MDS, or ALL following HCT from a haploidentical donor, MMUD, or MUD
Read the detailed description
A multi-center, non-randomized, controlled, multi-arm, Phase 1 interventional, open label, biologic assignment-based umbrella study is planned to evaluate the feasibility, safety, and preliminary efficacy of repeated dose regimen of TSC-100 and TSC-101 (TSC-100 and TSC-101 is a genetically engineered, donor-derived T cell targeting HA-1 and HA-2 respectively) in patients with AML, MDS, or ALL following HCT from a haploidentical donor, MUD, or MMUD.
The primary objective of this study is to investigate the safety of single and repeated dosing of TSC-100 and TSC-101 in HLA A*02:01 positive patients undergoing haploidentical allogeneic peripheral blood hematopoietic cell transplantation and determine the optimally tolerated dose range. The primary endpoints are: (1) incidence of dose-limiting toxicities (DLTs), and (2) incidence of adverse events (AEs) and serious AEs (SAEs) of TSC-100 and TSC-101 combined with the standard of care (SOC) compared with the SOC alone at 2 years of follow-up. The study will also investigate the efficacy of TSC-100 and TSC-101 combined with the SOC compared with that of the SOC alone to treat the study population and assess the immunogenicity of TSC-100 and TSC-101.
Depending on the HLA type and minor antigen positivity, patients will receive either TSC-100 or TSC-101 combined with the SOC or only SOC. TSC-100 or TSC-101 will be administered intravenously. Standard of care will include reduced intensity conditioning (RIC), hematopoietic cell infusion, and acute graft-versus-host disease (GvHD) prophylaxis. Patients will undergo one of the following RIC regimens, following standard institutional procedures: fludarabine+cyclophosphamide+total body irradiation, fludarabine+melphalan+/-total body irradiation, thiotepa+busulfan+fludarabine, flurdarabine+melphalan+thiotepa or fludarabine+melphalan (for MMUds only). In addition, patients may receive other supportive care measures and infectious prophylaxis as necessary, according to institutional guidelines or standards.
Successive cohorts of patients in the treatment arms will be started according to an interval 3+3 (i3+3) dose escalation design. Once the RP2D is identified, up to 20 additional patients may be enrolled at the RP2D. Dose escalations to the next cohort of TSC-100 and TSC-101 will be considered after the safety review committee (SRC) establishes reasonable safety for all patients enrolled into the current cohort. The safety and necessity of repeat dosing will also be determined by the SRC.
The safety data for all patients that received at least one dose of TSC-100 or TSC-101 in the treatment arms will be included in the safety assessment to proceed to the next dosing level and the dose escalation meeting will occur when the last patient in the cohort completes the 40-day DLT evaluation period. Depending on the number of DLTs observed, the range of patients that could be enrolled in the dose escalation stage of this i3+3 study is 35 to 300, including patients in the control arm.
- Being tested
- SOC + TSC-101, Control, SOC + TSC-100
- Keywords
- HA-2, TSC-101, AML, MDS, Adoptive Cell Therapy, T-cell receptor, T lymphocyte, TCR-engineered T cells, bone marrow transplant, haploidentical, allogeneic stem cell transplant, BMT, RIC, HSCT, Hematopoietic stem cell transplantation, ALLOHA-2, Mismatched unrelated donors MMUD, ALLOHA, HA-1, TSC-100
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOC + TSC-101Drug
HA-2 positive or HA-1 negative
ControlOther
SOC alone
SOC + TSC-100Drug
HA-1 positive
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm (TSC-100) | Experimental | HA-1 positive patients Receives: Drug: SOC + TSC-100 |
| Treatment Arm (TSC-101) | Experimental | HA-1 negative and HA-2 positive patients Receives: Drug: SOC + TSC-101 |
| Control Arm (Standard of Care) | Active comparator | Other: Control
SOC alone Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of dose limiting toxicities
Number of DLTs observed in patients compared to the control arm
Measured: 2 years
Occurrence of adverse events
Number of adverse events in patients compared to control arm
Measured: 2 years
Secondary outcomes (9)
Comparison of disease free survival in patients versus the control arm
Disease-free survival in patients versus the control arm at 6 months, defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up.
Measured: 6 months
Comparison of disease free survival in patients versus the control arm
Disease-free survival in patients versus the control arm at 12 months, defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up.
Measured: 12 months
Disease-free survival in patients versus the control arm at 18 months, defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up.
Disease-free survival at Month 18 defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up.
Measured: 18 months
Comparison of disease free survival in patients versus the control arm
Disease-free survival in patients versus the control arm at 24 months, defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up.
Measured: 24 months
Comparison of relapse rates between patients and control arm
Relapse rates in patients versus the control arm at 6 months. Relapse is defined by either morphological or cytogenetic evidence of acute leukemia or MDS consistent with pre-transplant features, or radiologic evidence of lymphoproliferative disorders, documented or not by biopsy.
Measured: 6 months
Comparison of relapse rates between patients and control arm
Relapse rates in patients versus the control arm at 12 months. Relapse is defined by either morphological or cytogenetic evidence of acute leukemia or MDS consistent with pre-transplant features, or radiologic evidence of lymphoproliferative disorders, documented or not by biopsy.
Measured: 12 months
Comparison of overall survival between patients and control arm
Overall survival between patients versus the control arm, defined as the time interval between the date of transplant and death from any cause. Surviving participants will be censored at the last follow up.
Measured: Up to 2 years
Anti TSC-100 antibodies
Presence and concentration of anti TSC-100 antibodies.
Measured: 2 years
Anti TSC-101 antibodies
Presence and concentration of anti TSC-101 antibodies.
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 posted26 Jul 2022
- Study start1 Nov 2022
- Primary completion1 Jun 2026
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 310 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TScan Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shrikanta Chattopadhyay, MD, Study director, Tscan Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05473910
- Sponsor's protocol ID
- TSCAN-001 (Phase 1)
- Status last verified
- Sep 2026
- First submitted
- 11 Jul 2022
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/3 Study Evaluating the Efficacy and Safety of T-Cell Receptor Engineered Donor T Cells in Subjects Undergoing Allogeneic Peripheral Blood Stem Cell Transplantation (ALLOHA-2)
- ClinicalTrials.gov ID
- NCT05473910
- Acronym / sponsor ID
- TSCAN-001 (Phase 1)
- Keywords
- HA-2, TSC-101, AML, MDS, Adoptive Cell Therapy, T-cell receptor, T lymphocyte, TCR-engineered T cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 310 participants (estimated)
- Lead sponsor
- TScan Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- Jun 2028 (estimated)
- First posted
- 26 Jul 2022 (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 multi-center, non-randomized, concurrent controlled, multi-arm, Phase 1 interventional, open-label, biologic assignment-based umbrella study evaluating the feasibility, safety and preliminary efficacy of an escalating dose regimen of up to 2 doses of TSC-100 and TSC-101 in patients with AML, MDS, or ALL following HCT from a haploidentical donor, MMUD, or MUD
Detailed description
A multi-center, non-randomized, controlled, multi-arm, Phase 1 interventional, open label, biologic assignment-based umbrella study is planned to evaluate the feasibility, safety, and preliminary efficacy of repeated dose regimen of TSC-100 and TSC-101 (TSC-100 and TSC-101 is a genetically engineered, donor-derived T cell targeting HA-1 and HA-2 respectively) in patients with AML, MDS, or ALL following HCT from a haploidentical donor, MUD, or MMUD.
The primary objective of this study is to investigate the safety of single and repeated dosing of TSC-100 and TSC-101 in HLA A*02:01 positive patients undergoing haploidentical allogeneic peripheral blood hematopoietic cell transplantation and determine the optimally tolerated dose range. The primary endpoints are: (1) incidence of dose-limiting toxicities (DLTs), and (2) incidence of adverse events (AEs) and serious AEs (SAEs) of TSC-100 and TSC-101 combined with the standard of care (SOC) compared with the SOC alone at 2 years of follow-up. The study will also investigate the efficacy of TSC-100 and TSC-101 combined with the SOC compared with that of the SOC alone to treat the study population and assess the immunogenicity of TSC-100 and TSC-101.
Depending on the HLA type and minor antigen positivity, patients will receive either TSC-100 or TSC-101 combined with the SOC or only SOC. TSC-100 or TSC-101 will be administered intravenously. Standard of care will include reduced intensity conditioning (RIC), hematopoietic cell infusion, and acute graft-versus-host disease (GvHD) prophylaxis. Patients will undergo one of the following RIC regimens, following standard institutional procedures: fludarabine+cyclophosphamide+total body irradiation, fludarabine+melphalan+/-total body irradiation, thiotepa+busulfan+fludarabine, flurdarabine+melphalan+thiotepa or fludarabine+melphalan (for MMUds only). In addition, patients may receive other supportive care measures and infectious prophylaxis as necessary, according to institutional guidelines or standards.
Successive cohorts of patients in the treatment arms will be started according to an interval 3+3 (i3+3) dose escalation design. Once the RP2D is identified, up to 20 additional patients may be enrolled at the RP2D. Dose escalations to the next cohort of TSC-100 and TSC-101 will be considered after the safety review committee (SRC) establishes reasonable safety for all patients enrolled into the current cohort. The safety and necessity of repeat dosing will also be determined by the SRC.
The safety data for all patients that received at least one dose of TSC-100 or TSC-101 in the treatment arms will be included in the safety assessment to proceed to the next dosing level and the dose escalation meeting will occur when the last patient in the cohort completes the 40-day DLT evaluation period. Depending on the number of DLTs observed, the range of patients that could be enrolled in the dose escalation stage of this i3+3 study is 35 to 300, including patients in the control arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm (TSC-100) | Experimental | Drug: SOC + TSC-100HA-1 positive patients |
| Treatment Arm (TSC-101) | Experimental | Drug: SOC + TSC-101HA-1 negative and HA-2 positive patients |
| Control Arm (Standard of Care) | Active comparator | Other: ControlOther: Control SOC alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Male or female aged ≥ 18 years at the time of signing the informed consent.
- Eastern Cooperative Oncology Group (ECOG)-PS ≤ 2 at the time of the screening visit.
- Contraceptive use by male and female participants must be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Male Participants:
- A male participant must agree to use a highly effective contraceptive as detailed in Appendix 4 of this protocol during the intervention period and for at least 12 months after the last dose of study intervention and refrain from donating sperm during this period.
Key exclusion criteria (12 listed)
- Medical or psychological conditions that would make the participant an unsuitable candidate for cell therapy including another concurrent uncontrolled malignancy or active CNS disease.
- The presence of organ toxicities will not necessarily exclude participants from enrolling on the protocol at the discretion of the PI; however, a delay in the infusion of HA1/HA2 TCRT cells may be required at the discretion of the treating investigator Participants with levels of donor-specific HLA antibodies that are considered by the treating investigator to be high enough to warrant desensitization protocols and who have no alternate donors.
- Participants who meet inclusion criteria for TSC-101 but who are also positive for HLAA02:07.
- Participants with evidence of clinically significant infection or uncontrolled viral r reactivation of cytomegalovirus (CMV), Epstein-Barr virus (EBV), Adenovirus, BK virus (BKV), or human herpesvirus 6 (HHV-6).
- Uncontrolled or symptomatic angina within the past 3 months. History of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, torsades de pointes). Atrial fibrillation with controlled ventricular response on treatment is not an exclusion.
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 |
|---|---|---|
| SOC + TSC-101HA-2 positive or HA-1 negative | Drug | Treatment Arm (TSC-101) |
| ControlSOC alone | Other | Control Arm (Standard of Care) |
| SOC + TSC-100HA-1 positive | Drug | Treatment Arm (TSC-100) |
Primary outcome
Occurrence of dose limiting toxicities
Time frame: 2 years
Number of DLTs observed in patients compared to the control arm
Occurrence of adverse events
Time frame: 2 years
Number of adverse events in patients compared to control arm
9 secondary outcomes
Comparison of disease free survival in patients versus the control arm
Time frame: 6 months
Comparison of disease free survival in patients versus the control arm
Time frame: 12 months
Disease-free survival in patients versus the control arm at 18 months, defined as the time from date of transplant to death or relapse/progression, whichever comes first. Participants alive and disease free will be censored at the last follow-up.
Time frame: 18 months
Comparison of disease free survival in patients versus the control arm
Time frame: 24 months
Comparison of relapse rates between patients and control arm
Time frame: 6 months
Comparison of relapse rates between patients and control arm
Time frame: 12 months
Comparison of overall survival between patients and control arm
Time frame: Up to 2 years
Anti TSC-100 antibodies
Time frame: 2 years
Anti TSC-101 antibodies
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- 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.
Shrikanta Chattopadhyay, MD study director
Tscan Therapeutics
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SOC + TSC-101 and SOC + TSC-100 in people with AML and MDS, run by TScan Therapeutics, Inc. at 21 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 25 inclusion and 12 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Occurrence of dose limiting toxicities (time frame: 2 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 5 Oct 2026.