Acute Myeloid LeukemiaPhase 1NCT04714372
FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia
A Phase 1 study testing Daratumumab/rHuPH20, FT538 and Fludarabine in people with Acute Myeloid Leukemia and Myeloid Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
This Phase I open-label dose escalation study is conducted in two stages with a primary endpoint to identify the maximum tolerated dose (MTD) of FT538 when administered with daratumumab in patients 12 years and older with advanced acute myeloid leukemia (AML) and related myeloid diseases. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Myeloid Leukemia, Monocytic Leukemia
- What is being tested?
- Daratumumab/rHuPH20, FT538 and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2021to 15 Oct 2024
- Phase
- Phase 1
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 12 years or older at the time of consent - Please note, enrollment of minors will be begin until permission to proceed is received from the FDA. At that time, the protocol will be updated to open enrollment to minors.
- Weight ≥ 50 kg due to FT538 fixed cell dosing and FT538 product pre-dose packaging
- Karnofsky performance status of 80-100% for 16 years and older or Lansky Play Score of 80-100 for ≥12 and < 16 years of age
- Evidence of adequate organ function within 14 days of starting study treatment defined as:
- Estimated Glomerular Filtration Rate (estimated creatinine clearance) ≥50 mL/min/1.73m^2
- Total bilirubin ≤ 5 × upper limit normal (ULN), not applicable for patients with Gilbert's syndrome
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- AST ≤3 × ULN and ALT ≤ 3 × ULN, not applicable if determined to be directly due to underlying malignancy
- LVEF ≥ 40% by echocardiogram or MUGA
- Contraceptive use by men or women
- Female subjects: Women of childbearing potential (WOCBP) must use a highly effective form of contraception from the screening visit until at least 12 months after the final dose of cyclophosphamide (CY), at least 4 months after the final dose of FT538, and at least 3 months after the final dose of daratumumab, whichever is latest.
- Male subjects: Males with a female partner of childbearing potential or a pregnant female partner must be sterile (biologically or surgically) or use a highly effective method of contraception from the screening visit until at least 4 months after the final dose of CY and at least 4 months after the final dose of FT538, and at least 3 months after the final dose of daratumumab, whichever is latest.
- Must agree to and sign the consent for the companion Long-Term Follow-Up study (UMN CPRC #2020LS166) to fulfill the FDA required 15 years of follow-up for a genetically modified cell product.
- Must agree to and sign the consent for the companion Long-Term Follow-Up study (UMN CPRC #2020LS166) to fulfill the FDA required 15 years of follow-up for a genetically modified cell product.
Who cannot join
- Diagnosis of acute promyelocytic leukemia (APL)
- Pregnant or breastfeeding, Menstruating females of child-bearing potential must have a negative pregnancy test within 14 days of study treatment start
- Known allergy to any of study drugs or their components
- Clinically significant cardiovascular disease including any of the following: myocardial infarction within 6 months prior to first study treatment; unstable angina or congestive heart failure of New York Heart Association Grade 2 or higher or cardiac ejection fraction <40%
- Any known condition that requires systemic immunosuppressive therapy (> 5mg prednisone daily or equivalent) during the FT538 dosing period (3 days before the 1st dose through 14 days after the last dose) excluding pre-medications - inhaled and topical steroids are permitted
- Receipt of any biological therapy, chemotherapy, or radiation therapy, except for palliative purposes, within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to the to the first dose of daratumumab. Maintenance hydroxyurea for blast control up to the initiation of lympho-conditioning is permitted
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- Known active central nervous system (CNS) involvement or treated CNS disease that has not cleared. If prior disease related CNS involvement must have completed effective treatment of their CNS disease at least 2 months prior to Day 1 with no evidence of disease clinically and at least stable findings on relevant CNS imaging
- Non-malignant CNS disease such as epilepsy, CNS vasculitis, or neurodegenerative disease or receipt of medications for these conditions in the 2-year period leading up to study enrollment
- Clinically significant untreated/uncontrolled infection
- Live vaccine <6 weeks prior to start of lympho-conditioning
- Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR
- Prior solid organ transplant
- Allogeneic HSCT relapse occurring <90 days after HSCT
- Active graft-versus-host-disease (GvHD) requiring systemic immunosuppression within 14 days prior to enrollment
- Presence of any medical or social issues that are likely to interfere with study conduct or may cause increased risk to the participant.
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Study of FT538 in Combination With Daratumumab in Acute Myeloid Leukemia
This Phase I open-label dose escalation study is conducted in two stages with a primary endpoint to identify the maximum tolerated dose (MTD) of FT538 when administered with daratumumab in patients 12 years and older with advanced acute myeloid leukemia (AML) and related myeloid diseases.
Read the detailed description
FT538 is an off the shelf product comprised of allogeneic natural killer (NK)-cell immunotherapy lacking CD38 and expressing hnCD16 and IL-15RF. Daratumumab is a targeted therapy (IgG1k human monoclonal antibody) that targets CD38.
FT538 is administered once a week for 3 consecutive weeks (Day 1, Day 8, and Day 15). Up to 5 dose levels will be tested. Fixed dose subcutaneous daratumumab is given on Day -12 and Day 5 prior to the NK cells as lymphodepletion, and on Day +3, Day +10, and Day +17 to maximize targeting. A short course of outpatient lymphodepleting chemotherapy is given on Day -4 and Day -3 to promote adoptive transfer. Day 1, the day of the 1st FT538 infusion, must be a Monday.
The primary analysis for Phase I is intent-to-treat in that all patients receiving the 1st infusion of FT538 are evaluable for toxicity and efficacy. Patients who discontinue therapy prior to the first FT538 will be replaced.
There are five potential FT538 dose cohorts. The starting dose is FT538 1x10e8 cells per dose with a lower safety dose of 5x10e7 if needed (Dose Level -1). The subsequent planned FT538 cohorts are 3x10e8, 1x10e9, and 1.5 x10e9 FT538 cells per dose. Dosing is based on hnCD16 expression, where 90% ± 10% of administered FT538 cells express hnCD16. The trial is conducted with no intra-patient escalation.
- Conditions
- Acute Myeloid Leukemia, Myeloid Leukemia, Monocytic Leukemia
- Being tested
- Daratumumab/rHuPH20, FT538, Fludarabine, Cyclophosphamide
- Keywords
- FT538, AML, Daratumumab, CD38
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, Myeloid, Leukemia, Monocytic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Daratumumab/rHuPH20Drug
Also called Darzalex
Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches [7.5 cm] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
FT538Drug
FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
FludarabineDrug
Also called FLUDARA
Fludarabine 25 mg/m^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
CyclophosphamideDrug
Also called CYTOXAN, NEOSAR
Cyclophosphamide 300 mg/m^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1: FT538 at 1 x10^8 cells/dose | Experimental | FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15 Receives: Drug: Daratumumab/rHuPH20; Drug: FT538; Drug: Fludarabine; Drug: Cyclophosphamide |
| Dose Level 2: FT538 at 3 x10^8 cells/dose | Experimental | FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15 Receives: Drug: Daratumumab/rHuPH20; Drug: FT538; Drug: Fludarabine; Drug: Cyclophosphamide |
| Dose Level 3: FT538 at 1 x10^9 cells/dose | Experimental | FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15 Receives: Drug: Daratumumab/rHuPH20; Drug: FT538; Drug: Fludarabine; Drug: Cyclophosphamide |
| Dose Level 4: FT538 at 1.5 x10^9 cells/dose | Experimental | FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15 Receives: Drug: Daratumumab/rHuPH20; Drug: FT538; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events
Dose limiting toxicity (DLT) is defined as any AE (based on CTCAE v5) that is at least possibly related to FT538 that occurs after the first FT538 infusion through the end of the DLT assessment period on Day 29 as defined below:
Any Grade 4 non-hematologic AE, Grade 3 pulmonary or cardiac AE of any duration, Grade 3 immune cell associated neurotoxicity syndrome (ICANS) of any duration, Any other Grade 3 non-hematologic AE of >72 hours duration or Grade ≥2 acute GvHD requiring systemic steroid administration
Measured: 42 days from the 1st FT538 infusion
Secondary outcomes (5)
Number of Participants Achieving Complete Remission (CR + CRi)
Efficacy of treatment is measured by the objective response rate (Complete Remission [CR] + Complete Remission with Incomplete Hematologic Recovery [CRi]) assessed by Day 28 based on the 2017 European LeukemiaNet (ELN) response criteria CR - defined as bone marrow blast <5%, absence of circulating blasts and blasts with auer rods, absence of extramedullary disease, Absolute neutrophil count >= 1.0 × 10e9/L (1000/μL) and platelet count >=100 × 10e9/L 100,000/μL) CRi - defined as all CR criterial except for residual neutropenia (<1.0 × 10e9/L [1000/μL]) or thrombocytopenia (<100 × 10e9/L [100,000/μL])
Measured: 28 days from the 1st FT538 infusion
Overall Response Rate
Overall response rate is defined as number of patients who have a partial or complete response to therapy divided by the total number of patients who received treatment.
Response criteria will be based on 2017 European LeukemiaNet (ELN) response criteria assessing the bone marrow blast percentage, presence/absence of circulating blasts, presence/absence of blasts with auer rods, presence/absence of extramedullary disease, Absolute neutrophil counts per liter pf blood and platelet counts per liter blood
Measured: 12 months from the 1st FT538 infusion
Percentage of Participants With Progression Free Survival (PFS)
Percentage of participants experiencing progression free survival at one year follow up
Measured: 12 months from the 1st FT538 infusion
Percentage of Participants With Overall Survival (OS)
Percentage of participants with Overall Survival (OS) at one year follow up
Measured: 12 months from the 1st FT538 infusion
Number of Participants Experiencing Adverse Events
Number of participants experiencing adverse events with the combination of Daratumumab and FT538
Measured: 12 months from the 1st FT538 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2021
- Study start3 Nov 2021
- Primary completion9 Jan 2024
- Study completion15 Oct 2024
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 Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- 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
- Sequential
- Model description
- This study is performed in two stages, with Stage 1 having two potential steps. A minimum of 28 days separates each patient cohort. Stage 1 step 1 uses a fast-track design (1 patient per cohort) starting at Dose Level 1. The study moves to Stage 1 Step 2 when a pre-defined adverse event occurs during fast-track enrollment, specifically, any Grade 3 non-hematologic event within 72 hours after an FT538 infusion. The cohort size increases from 1 to 3 patients with 2 additional patients added to the current cohort if the event being a Dose Limiting Toxicity (DLT) event. No intra-cohort staggering is required. Escalation in Step 2 continues until the 1st DLT event at which point Stage 2 (CRM) is activated. Stage 2 follows Continual Reassessment Method (CRM) and is initiated at the 1st DLT
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Maakaron, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04714372
- Sponsor's protocol ID
- 2020LS114
- Other IDs
- MT2020-33
- Status last verified
- Oct 2024
- First submitted
- 14 Jan 2021
- Last updated
- 24 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of FT538 in Combination With Daratumumab in Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT04714372
- Acronym / sponsor ID
- 2020LS114
- Conditions
- Acute Myeloid Leukemia, Myeloid Leukemia, Monocytic Leukemia
- Keywords
- FT538, AML, Daratumumab, CD38
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 9 Jan 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 19 Jan 2021 (actual)
- Results
- Posted 24 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase I open-label dose escalation study is conducted in two stages with a primary endpoint to identify the maximum tolerated dose (MTD) of FT538 when administered with daratumumab in patients 12 years and older with advanced acute myeloid leukemia (AML) and related myeloid diseases.
Detailed description
FT538 is an off the shelf product comprised of allogeneic natural killer (NK)-cell immunotherapy lacking CD38 and expressing hnCD16 and IL-15RF. Daratumumab is a targeted therapy (IgG1k human monoclonal antibody) that targets CD38.
FT538 is administered once a week for 3 consecutive weeks (Day 1, Day 8, and Day 15). Up to 5 dose levels will be tested. Fixed dose subcutaneous daratumumab is given on Day -12 and Day 5 prior to the NK cells as lymphodepletion, and on Day +3, Day +10, and Day +17 to maximize targeting. A short course of outpatient lymphodepleting chemotherapy is given on Day -4 and Day -3 to promote adoptive transfer. Day 1, the day of the 1st FT538 infusion, must be a Monday.
The primary analysis for Phase I is intent-to-treat in that all patients receiving the 1st infusion of FT538 are evaluable for toxicity and efficacy. Patients who discontinue therapy prior to the first FT538 will be replaced.
There are five potential FT538 dose cohorts. The starting dose is FT538 1x10e8 cells per dose with a lower safety dose of 5x10e7 if needed (Dose Level -1). The subsequent planned FT538 cohorts are 3x10e8, 1x10e9, and 1.5 x10e9 FT538 cells per dose. Dosing is based on hnCD16 expression, where 90% ± 10% of administered FT538 cells express hnCD16. The trial is conducted with no intra-patient escalation.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- This study is performed in two stages, with Stage 1 having two potential steps. A minimum of 28 days separates each patient cohort. Stage 1 step 1 uses a fast-track design (1 patient per cohort) starting at Dose Level 1. The study moves to Stage 1 Step 2 when a pre-defined adverse event occurs during fast-track enrollment, specifically, any Grade 3 non-hematologic event within 72 hours after an FT538 infusion. The cohort size increases from 1 to 3 patients with 2 additional patients added to the current cohort if the event being a Dose Limiting Toxicity (DLT) event. No intra-cohort staggering is required. Escalation in Step 2 continues until the 1st DLT event at which point Stage 2 (CRM) is activated. Stage 2 follows Continual Reassessment Method (CRM) and is initiated at the 1st DLT
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1: FT538 at 1 x10^8 cells/dose | Experimental | Drug: Daratumumab/rHuPH20, Drug: FT538, Drug: Fludarabine, Drug: CyclophosphamideFT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15 |
| Dose Level 2: FT538 at 3 x10^8 cells/dose | Experimental | Drug: Daratumumab/rHuPH20, Drug: FT538, Drug: Fludarabine, Drug: CyclophosphamideFT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15 |
| Dose Level 3: FT538 at 1 x10^9 cells/dose | Experimental | Drug: Daratumumab/rHuPH20, Drug: FT538, Drug: Fludarabine, Drug: CyclophosphamideFT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15 |
| Dose Level 4: FT538 at 1.5 x10^9 cells/dose | Experimental | Drug: Daratumumab/rHuPH20, Drug: FT538, Drug: Fludarabine, Drug: CyclophosphamideFT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15 |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Age 12 years or older at the time of consent - Please note, enrollment of minors will be begin until permission to proceed is received from the FDA. At that time, the protocol will be updated to open enrollment to minors.
- Weight ≥ 50 kg due to FT538 fixed cell dosing and FT538 product pre-dose packaging
- Karnofsky performance status of 80-100% for 16 years and older or Lansky Play Score of 80-100 for ≥12 and < 16 years of age
- Evidence of adequate organ function within 14 days of starting study treatment defined as:
- Contraceptive use by men or women
Key exclusion criteria (15 listed)
- Diagnosis of acute promyelocytic leukemia (APL)
- Pregnant or breastfeeding, Menstruating females of child-bearing potential must have a negative pregnancy test within 14 days of study treatment start
- Known allergy to any of study drugs or their components
- Clinically significant cardiovascular disease including any of the following: myocardial infarction within 6 months prior to first study treatment; unstable angina or congestive heart failure of New York Heart Association Grade 2 or higher or cardiac ejection fraction <40%
- Any known condition that requires systemic immunosuppressive therapy (> 5mg prednisone daily or equivalent) during the FT538 dosing period (3 days before the 1st dose through 14 days after the last dose) excluding pre-medications - inhaled and topical steroids are permitted
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 |
|---|---|---|
| Daratumumab/rHuPH20Also: DarzalexDaratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches [7.5 cm] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion. | Drug | Dose Level 1: FT538 at 1 x10^8 cells/dose, Dose Level 2: FT538 at 3 x10^8 cells/dose, Dose Level 3: FT538 at 1 x10^9 cells/dose, Dose Level 4: FT538 at 1.5 x10^9 cells/dose |
| FT538FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15 | Drug | Dose Level 1: FT538 at 1 x10^8 cells/dose, Dose Level 2: FT538 at 3 x10^8 cells/dose, Dose Level 3: FT538 at 1 x10^9 cells/dose, Dose Level 4: FT538 at 1.5 x10^9 cells/dose |
| FludarabineAlso: FLUDARAFludarabine 25 mg/m^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3). | Drug | Dose Level 1: FT538 at 1 x10^8 cells/dose, Dose Level 2: FT538 at 3 x10^8 cells/dose, Dose Level 3: FT538 at 1 x10^9 cells/dose, Dose Level 4: FT538 at 1.5 x10^9 cells/dose |
| CyclophosphamideAlso: CYTOXAN, NEOSARCyclophosphamide 300 mg/m^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given. | Drug | Dose Level 1: FT538 at 1 x10^8 cells/dose, Dose Level 2: FT538 at 3 x10^8 cells/dose, Dose Level 3: FT538 at 1 x10^9 cells/dose, Dose Level 4: FT538 at 1.5 x10^9 cells/dose |
Primary outcome
Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events
Time frame: 42 days from the 1st FT538 infusion
Dose limiting toxicity (DLT) is defined as any AE (based on CTCAE v5) that is at least possibly related to FT538 that occurs after the first FT538 infusion through the end of the DLT assessment period on Day 29 as defined below: Any Grade 4 non-hematologic AE, Grade 3 pulmonary or cardiac AE of any duration, Grade 3 immune cell associated neurotoxicity syndrome (ICANS) of any duration, Any other Grade 3 non-hematologic AE of >72 hours duration or Grade ≥2 acute GvHD requiring systemic steroid administration
5 secondary outcomes
Number of Participants Achieving Complete Remission (CR + CRi)
Time frame: 28 days from the 1st FT538 infusion
Overall Response Rate
Time frame: 12 months from the 1st FT538 infusion
Percentage of Participants With Progression Free Survival (PFS)
Time frame: 12 months from the 1st FT538 infusion
Percentage of Participants With Overall Survival (OS)
Time frame: 12 months from the 1st FT538 infusion
Number of Participants Experiencing Adverse Events
Time frame: 12 months from the 1st FT538 infusion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
- 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.
Joseph Maakaron, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Daratumumab/rHuPH20, FT538 and Fludarabine in people with Acute Myeloid Leukemia and Myeloid Leukemia, run by Masonic Cancer Center, University of Minnesota at 1 site 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 13 inclusion and 15 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: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 24 Oct 2024). 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?
Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events (time frame: 42 days from the 1st FT538 infusion). 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 24 Oct 2024.