Recurrent Acute Myeloid LeukemiaPhase 1NCT06871410
Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study testing Autologous Anti-CD83 CAR T-cells, Biospecimen Collection and Chest Radiography in people with Recurrent Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This phase I trial tests the safety, side effects, and best dose of genetically engineered cells (CD83 chimeric antigen receptor [CAR] T cells) in treating patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Acute Myeloid Leukemia, Refractory Acute Myeloid Leukemia
- What is being tested?
- Autologous Anti-CD83 CAR T-cells, Biospecimen Collection and Chest Radiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to 1 Apr 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
- Age ≥ 18 years old.
- Karnofsky performance status score ≥ 70%.
- Relapsed or refractory AML based upon ELN 2022 criteria.
- Creatinine clearance: ≥ 40 mL/min (Cockroft-Gault).
- Total bilirubin: ≤ 2mg/dL except for patients with Gilbert's syndrome, hemolysis, or related to disease.
- Aspartate aminotransferase (AST) and alanine transaminase (ALT) < 3.0 x upper limit of normal (ULN).
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- Left ventricular (LV) ejection fraction: > 45% and be free of symptomatic congestive heart failure or uncontrolled arrhythmia.
- Oxygen (O2) saturation: ≥ 92% on room air without needs for supplemental O2.
- Absolute lymphocyte count: ≥ 0.2 x 10^9/L, HCT of ≥ 27% and platelets of ≥ 20 x 10^9/L. Transfusion support is allowed to meet HCT and platelet parameters prior to apheresis.
- Life expectancy ≥12 weeks from the time of enrollment, per clinical judgment.
- Negative serum pregnancy test in females of child-bearing potential (FOCBP). FOCBP is defined as any female who has experienced menarche and who has not undergone successful surgical sterilization or who is not postmenopausal.
- If history of allogeneic HCT, must have completed transplant at least 3 months prior, be off immunosuppression, including ruxolitinib, at least 2 weeks prior to apheresis, and have no evidence of GVHD requiring treatment at enrollment.
- Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry and for 12 months following duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
- Participants must be considered preliminarily eligible for an allogeneic hematopoietic cell transplantation, with potential donors identified per a transplant and cellular therapy consult at Roswell Park Comprehensive Cancer Center.
- Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure.
Who cannot join
- Concomitant systemic glucocorticoid use at a dose equivalent to > 10 mg daily prednisone at the time of apheresis and/or within 4 weeks of CD83 CAR T infusion for any reasons other than GVHD.
- Diagnosis of acute promyelocytic leukemia (APL; AML M3 by French-American-British [FAB] classification).
- Active central nervous system (CNS) leukemia; patients with history of CNS leukemia in complete response (CR) are eligible.
- Patients enrolled in another investigational therapy protocol for their disease within 14 days or 5 half-lives prior to leukapheresis, whichever is shorter.
- Patients requiring agents or any treatments other than hydroxyurea, single agent cytarbine,hypomethylating agents with or without ventoclax and/or targeted agents (i.e., FLT3, IDH2 or IDH1 inhibitors) to control blast counts within 14 days or 5 half-lives (whichever is shorter) prior to lymphodepletion.
- Ongoing uncontrolled serious infection, pulmonary disease or psycho/social concerns.
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- HIV seropositivity or active hepatitis B or C infection within (defined by positive polymerase chain reaction [PCR]) 4 weeks of enrollment.
- Other active malignancy within 2 years of study entry, except for basal cell cancer of skin, cervical cancer treated surgically with curative intent or localized prostate cancer managed with observational approach.
- Active grade II-IV acute GVHD in patients with relapsed AML after HCT requiring treatment.
- Prior solid organ transplant.
- Active autoimmune disease requiring immunosuppressive therapy.
- Pregnant or nursing female participants.
- Unwilling or unable to follow protocol requirements.
- Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive study drug.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Ask RPCI, 800-767-9355, askrpci@roswellpark.org
Chelsea Peterson, DO
About this study
Official title: CD83 CAR T in Relapsed or Refractory Acute Myeloid Leukemia (AML): A Phase I Trial
This phase I trial tests the safety, side effects, and best dose of genetically engineered cells (CD83 chimeric antigen receptor [CAR] T cells) in treating patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). CD83 is a protein that is found on AML blasts. Blasts are abnormal immature white blood cells that can multiply uncontrollably: filling up the bone marrow and preventing the production of other cells important for survival. CD83 CAR T cells represent a new cell therapy to eliminate AML blasts, while avoiding the risk for graft versus host disease (GVHD) after stem cell transplant to replace bone marrow or, tumor toxicity like myeloid aplasia where the body's own immune system causes damage to the bone marrow stem cells. Therefore, human CD83 CAR T cells are a promising cell-based approach to preventing two critical complications of stem-cell transplant - GVHD and relapse. Giving CD83 CAR T cells may be safe, tolerable, and/or effective in treating patients with relapsed or refractory AML.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety and determine the maximal tolerated dose (MTD) of autologous anti-CD83 CAR T-cells (CD83 CAR T cells) administered as a single infusion to refractory/relapsed acute myeloid leukemia (AML) patients.
SECONDARY OBJECTIVES:
- To observe and record activity against AML. II. To evaluate response for AML using 2022 European Leukemia Net (ELN) criteria.
III. To evaluate progression-free and overall survival after CAR T cell infusion.
IV. To evaluate the time to hematological recovery after CAR T cell infusion. V. To evaluate in vivo CAR T cell expansion and persistence. VI. To evaluate acute GVHD within 6 weeks after infusion of CAR T cells in patients who relapsed after allogeneic hematopoietic cell transplantation (HCT).
VII. To evaluate the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
EXPLORATORY OBJECTIVES:
- To evaluate the relationship between cytokine expression and cytokine release syndrome (CRS).
II. To determine predictors of response and mechanisms or resistance to CAR-T cells.
III. To evaluate immune effects by CD83 CAR T cells on peripheral blood T cell subsets, B cells and dendritic cells.
IV. To evaluate the relationship between baseline levels of CD83 expression on AML blasts and response following CAR T cell infusion.
- To evaluate the relationship between proportion of infused CAR T cell subsets (γδ T cells versus [vs.] αβ T cells) and disease response.
VI. To evaluate immunity after CAR T cell infusion. VII. To determine the rate of successful manufacturing and time required to complete.
VIII. To evaluate for CAR T phenotype, exhaustion, and CAR versus non-CAR subsets associated with response and relapse.
IX. Evaluate the effect of CAR T infusion on quality of life.
OUTLINE:
Patients undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMCs) for CD83 CAR T cell product manufacturing on day -21 and may receive hydroxyurea at the discretion of the treating physician on study. Patients then receive fludarabine intravenously (IV) over 30 minutes and cyclophosphamide IV over 2 hours on days -5 to -3 in the absence of disease progression or unacceptable toxicity. Patients then receive CD83 CAR T cells IV over 15 minutes on day 0. Patients also undergo echocardiography (ECHO) and chest x-ray during screening, blood sample collection throughout the study, and computed tomography (CT) and/or positron emission tomography (PET), as well as lumbar puncture as clinically indicated. In addition, patients may undergo bone marrow aspiration throughout the study.
After completion of study treatment, patients are followed up every 2 weeks for 2 months then at 3, 6, and 12 months.
- Being tested
- Autologous Anti-CD83 CAR T-cells, Biospecimen Collection, Chest Radiography, Computed Tomography, Cyclophosphamide
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Anti-CD83 CAR T-cellsDrug
Also called Autologous Anti-CD83 CAR T Cells; Autologous Anti-CD83 CAR-T Cells
Given IV
Biospecimen CollectionProcedure or surgery
Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo bone marrow aspiration blood sample collection
Chest RadiographyProcedure or surgery
Also called Chest X-ray
Undergo chest x-ray
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo CT
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518
Given IV
EchocardiographyProcedure or surgery
Also called EC
Undergo ECHO
Also called 2-F-ara-AMP, 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-, Beneflur, Fludara
Given IV
HydroxyureaDrug
Also called Droxia, Hydrea, Hydroxycarbamide, Litalir
Given hydroxyurea
LeukapheresisProcedure or surgery
Also called Leukocyte Adsorptive Apheresis, Leukocytopheresis, Therapeutic Leukopheresis, White Blood Cell Reduction Apheresis
Undergo leukapheresis
Lumbar PunctureProcedure or surgery
Also called LP, Spinal Tap
Undergo lumbar puncture
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)
Undergo PET
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Treatment (fludarabine, cyclophosphamide, CD83 CAR T-cells) | Experimental | Patients undergo leukapheresis to obtain PBMCs for CD83 CAR T-cell product manufacturing on day -21 and may receive hydroxyurea at the discretion of the treating physician on study. Patients then receive fludarabine IV over 30 minutes and cyclophosphamide IV over 2 hours on days -5 to -3 in the absence of disease progression or unacceptable toxicity. Patients then receive CD83 CAR T-cells IV over 15 minutes on day 0. Patients also undergo ECHO and chest x-ray during screening, blood sample collection throughout the study, and CT and/or PET, as well as lumbar puncture as clinically indicated. In addition, patients may undergo bone marrow aspiration throughout the study. Receives: Drug: Autologous Anti-CD83 CAR T-cells; Procedure: Biospecimen Collection; Procedure: Chest Radiography; Procedure: Computed Tomography; Drug: Cyclophosphamide; Procedure: Echocardiography; Drug: Fludarabine Phosphate; Drug: Hydroxyurea; Procedure: Leukapheresis; Procedure: Lumbar Puncture; Procedure: Positron Emission Tomography; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose-limiting toxicity (DLT)
Will be defined as any adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) version (v)5. Cytokine release syndrome(CRS)/immune effector cell-associated neurotoxicity syndrome will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Guidelines. The DLTs will be summarized by dose level using frequencies and relative frequencies. Will employ the Bayesian optimal interval design to find the maximal tolerated dose (MTD). The target DLT rate for the MTD is = 0.33.
Measured: Up to 28 days
Secondary outcomes (10)
Objective response
Will be determine as the number of patients achieving complete remission, partial remission, and/or morphologic leukemia free state by 2022 European Leukemia Net Response Criteria. Will be summarized by dose level using frequencies and relative frequencies. Rates will be estimated using 95% credible regions obtained by Jeffrey's prior method. As exploratory analyses, comparisons between dose levels may be made using Fisher's exact test.
Measured: At 28 days and 1 year
Overall survival
Will be summarized by dose level using cumulative incidence or Kaplan-Meier curves, as appropriate. Estimates of the median times will be obtained with 95% confidence intervals calculated using the log-log transformation. As exploratory analyses, comparisons between dose levels may be made using Gray's or the log-rank test, as appropriate.
Measured: From treatment initiation until death due to any cause or last follow-up, assessed up to 1 year
Progression-free survival
Will be summarized by dose level using cumulative incidence or Kaplan-Meier curves, as appropriate. Estimates of the median times will be obtained with 95% confidence intervals calculated using the log-log transformation. As exploratory analyses, comparisons between dose levels may be made using Gray's or the log-rank test, as appropriate.
Measured: From treatment initiation until disease progression/relapse, death due to any cause, subsequent treatment (censored), or last follow-up, assessed up to 1 year
Hematologic recovery
Will be assessed by achieving an absolute neutrophil count recovery (> 0.5 x 10^9/L). Will be summarized by dose level using frequencies and relative frequencies. Rates will be estimated using 95% credible regions obtained by Jeffrey's prior method. As exploratory analyses, comparisons between dose levels may be made using Fisher's exact test.
Measured: At 28 days
Time to hematologic recovery
Relapse or death will be considered the competing risk. Will be summarized by dose level using cumulative incidence or Kaplan-Meier curves, as appropriate. Estimates of the median times will be obtained with 95% confidence intervals calculated using the log-log transformation. As exploratory analyses, comparisons between dose levels may be made using Gray's or the log-rank test, as appropriate.
Measured: From treatment initiation until hematologic recovery or last follow-up, assessed up to 1 year
Acute graft-versus-host disease (GVHD)
Will be defined as a grade II-IV acute GVHD. Will be summarized by dose level using cumulative incidence or Kaplan-Meier curves, as appropriate. Estimates of the median times will be obtained with 95% confidence intervals calculated using the log-log transformation. As exploratory analyses, comparisons between dose levels may be made using Gray's or the log-rank test, as appropriate.
Measured: Up to 6 weeks
Time to GVHD
Relapse or death will be considered the competing risk. Will be summarized by dose level using cumulative incidence or Kaplan-Meier curves, as appropriate. Estimates of the median times will be obtained with 95% confidence intervals calculated using the log-log transformation. As exploratory analyses, comparisons between dose levels may be made using Gray's or the log-rank test, as appropriate.
Measured: From treatment initiation until grade II-IV GVHD, 6 weeks post infusion, or last follow-up, assessed up to 1 year
Treatment-related adverse events
Will be defined as by CTCAE v5 and CRS by ASTCT Consensus Grading for CRS and Neurological Toxicity Associated with Immune Effector Cells. Will be summarized by dose level using frequencies and relative frequencies. Rates will be estimated using 95% credible regions obtained by Jeffrey's prior method. As exploratory analyses, comparisons between dose levels may be made using Fisher's exact test.
Measured: Up to 12 months
Time to treatment related adverse event
Relapse or death will be considered the competing risk. Will be summarized by dose level using cumulative incidence or Kaplan-Meier curves, as appropriate. Estimates of the median times will be obtained with 95% confidence intervals calculated using the log-log transformation. As exploratory analyses, comparisons between dose levels may be made using Gray's or the log-rank test, as appropriate
Measured: From treatment initiation until a treatment related adverse event, 12 months post infusion, or last follow-up, assessed up to 1 year
Number of peripheral blood chimeric antigen receptor (CAR) T cells
Will be summarized by dose level and timepoint (pre- and post-therapy) using the mean, median, and standard deviation; and graphically using dot plots. The log absolute number of CD83 CAR T cells per peripheral blood volume will be modeled as a function of dose level, time, their two-way interaction, and a random subject effect using a linear mixed model. Tests about the appropriate contrasts on model estimates will be sued to compare: 1) changes relative to pre-therapy within each dose level, and 2) changes at a given timepoint between dose levels. All model assumptions will be verified graphically, and transformations applied as appropriate.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start2 Feb 2026
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Acute Myeloid LeukemiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Chelsea Peterson, DO, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871410
- Sponsor's protocol ID
- I-3916824
- Other IDs
- NCI-2025-01523, CDMRP-CA250315
- Status last verified
- Sep 2026
- First submitted
- 10 Mar 2025
- Last updated
- 24 Sep 2026
- Results posted
- No
- 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 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CD83 CAR T in Relapsed or Refractory Acute Myeloid Leukemia (AML): A Phase I Trial
- ClinicalTrials.gov ID
- NCT06871410
- Acronym / sponsor ID
- I-3916824
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 12 Mar 2025 (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 phase I trial tests the safety, side effects, and best dose of genetically engineered cells (CD83 chimeric antigen receptor [CAR] T cells) in treating patients with acute myeloid leukemia (AML) that has come back after a period of improvement (relapsed) or has not responded to previous treatment (refractory). CD83 is a protein that is found on AML blasts. Blasts are abnormal immature white blood cells that can multiply uncontrollably: filling up the bone marrow and preventing the production of other cells important for survival. CD83 CAR T cells represent a new cell therapy to eliminate AML blasts, while avoiding the risk for graft versus host disease (GVHD) after stem cell transplant to replace bone marrow or, tumor toxicity like myeloid aplasia where the body's own immune system causes damage to the bone marrow stem cells. Therefore, human CD83 CAR T cells are a promising cell-based approach to preventing two critical complications of stem-cell transplant - GVHD and relapse. Giving CD83 CAR T cells may be safe, tolerable, and/or effective in treating patients with relapsed or refractory AML.
Detailed description
PRIMARY OBJECTIVE:
- To evaluate the safety and determine the maximal tolerated dose (MTD) of autologous anti-CD83 CAR T-cells (CD83 CAR T cells) administered as a single infusion to refractory/relapsed acute myeloid leukemia (AML) patients.
SECONDARY OBJECTIVES:
- To observe and record activity against AML. II. To evaluate response for AML using 2022 European Leukemia Net (ELN) criteria.
III. To evaluate progression-free and overall survival after CAR T cell infusion.
IV. To evaluate the time to hematological recovery after CAR T cell infusion. V. To evaluate in vivo CAR T cell expansion and persistence. VI. To evaluate acute GVHD within 6 weeks after infusion of CAR T cells in patients who relapsed after allogeneic hematopoietic cell transplantation (HCT).
VII. To evaluate the incidence of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
EXPLORATORY OBJECTIVES:
- To evaluate the relationship between cytokine expression and cytokine release syndrome (CRS).
II. To determine predictors of response and mechanisms or resistance to CAR-T cells.
III. To evaluate immune effects by CD83 CAR T cells on peripheral blood T cell subsets, B cells and dendritic cells.
IV. To evaluate the relationship between baseline levels of CD83 expression on AML blasts and response following CAR T cell infusion.
- To evaluate the relationship between proportion of infused CAR T cell subsets (γδ T cells versus [vs.] αβ T cells) and disease response.
VI. To evaluate immunity after CAR T cell infusion. VII. To determine the rate of successful manufacturing and time required to complete.
VIII. To evaluate for CAR T phenotype, exhaustion, and CAR versus non-CAR subsets associated with response and relapse.
IX. Evaluate the effect of CAR T infusion on quality of life.
OUTLINE:
Patients undergo leukapheresis to obtain peripheral blood mononuclear cells (PBMCs) for CD83 CAR T cell product manufacturing on day -21 and may receive hydroxyurea at the discretion of the treating physician on study. Patients then receive fludarabine intravenously (IV) over 30 minutes and cyclophosphamide IV over 2 hours on days -5 to -3 in the absence of disease progression or unacceptable toxicity. Patients then receive CD83 CAR T cells IV over 15 minutes on day 0. Patients also undergo echocardiography (ECHO) and chest x-ray during screening, blood sample collection throughout the study, and computed tomography (CT) and/or positron emission tomography (PET), as well as lumbar puncture as clinically indicated. In addition, patients may undergo bone marrow aspiration throughout the study.
After completion of study treatment, patients are followed up every 2 weeks for 2 months then at 3, 6, and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (fludarabine, cyclophosphamide, CD83 CAR T-cells) | Experimental | Drug: Autologous Anti-CD83 CAR T-cells, Procedure: Biospecimen Collection, Procedure: Chest Radiography, Procedure: Computed Tomography, Drug: Cyclophosphamide, Procedure: Echocardiography, Drug: Fludarabine Phosphate, Drug: Hydroxyurea, Procedure: Leukapheresis, Procedure: Lumbar Puncture, Procedure: Positron Emission Tomography, Other: Questionnaire AdministrationPatients undergo leukapheresis to obtain PBMCs for CD83 CAR T-cell product manufacturing on day -21 and may receive hydroxyurea at the discretion of the treating physician on study. Patients then receive fludarabine IV over 30 minutes and cyclophosphamide IV over 2 hours on days -5 to -3 in the absence of disease progression or unacceptable toxicity. Patients then receive CD83 CAR T-cells IV over 15 minutes on day 0. Patients also undergo ECHO and chest x-ray during screening, blood sample collection throughout the study, and CT and/or PET, as well as lumbar puncture as clinically indicated. In addition, patients may undergo bone marrow aspiration throughout the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age ≥ 18 years old.
- Karnofsky performance status score ≥ 70%.
- Relapsed or refractory AML based upon ELN 2022 criteria.
- Creatinine clearance: ≥ 40 mL/min (Cockroft-Gault).
- Total bilirubin: ≤ 2mg/dL except for patients with Gilbert's syndrome, hemolysis, or related to disease.
Key exclusion criteria (14 listed)
- Concomitant systemic glucocorticoid use at a dose equivalent to > 10 mg daily prednisone at the time of apheresis and/or within 4 weeks of CD83 CAR T infusion for any reasons other than GVHD.
- Diagnosis of acute promyelocytic leukemia (APL; AML M3 by French-American-British [FAB] classification).
- Active central nervous system (CNS) leukemia; patients with history of CNS leukemia in complete response (CR) are eligible.
- Patients enrolled in another investigational therapy protocol for their disease within 14 days or 5 half-lives prior to leukapheresis, whichever is shorter.
- Patients requiring agents or any treatments other than hydroxyurea, single agent cytarbine,hypomethylating agents with or without ventoclax and/or targeted agents (i.e., FLT3, IDH2 or IDH1 inhibitors) to control blast counts within 14 days or 5 half-lives (whichever is shorter) prior to lymphodepletion.
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 |
|---|---|---|
| Autologous Anti-CD83 CAR T-cellsAlso: Autologous Anti-CD83 CAR T Cells; Autologous Anti-CD83 CAR-T CellsGiven IV | Drug | Treatment (fludarabine, cyclophosphamide, CD83 CAR T-cells) |
| Biospecimen CollectionAlso: Biological Sample Collection, Biospecimen Collected, Specimen CollectionUndergo bone marrow aspiration blood sample collection | Procedure or surgery | Treatment (fludarabine, cyclophosphamide, CD83 CAR T-cells) |
| Chest RadiographyAlso: Chest X-rayUndergo chest x-ray | Procedure or surgery | Treatment (fludarabine, cyclophosphamide, CD83 CAR T-cells) |
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo CT | Procedure or surgery | Treatment (fludarabine, cyclophosphamide, CD83 CAR T-cells) |
| CyclophosphamideAlso: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Asta B 518, B 518Given IV | Drug | Treatment (fludarabine, cyclophosphamide, CD83 CAR T-cells) |
| EchocardiographyAlso: ECUndergo ECHO | Procedure or surgery | Treatment (fludarabine, cyclophosphamide, CD83 CAR T-cells) |
| Fludarabine PhosphateAlso: 2-F-ara-AMP, 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-.beta.-D-arabinofuranosyl)-, Beneflur, FludaraGiven IV | Drug | Treatment (fludarabine, cyclophosphamide, CD83 CAR T-cells) |
| HydroxyureaAlso: Droxia, Hydrea, Hydroxycarbamide, LitalirGiven hydroxyurea | Drug | Treatment (fludarabine, cyclophosphamide, CD83 CAR T-cells) |
| LeukapheresisAlso: Leukocyte Adsorptive Apheresis, Leukocytopheresis, Therapeutic Leukopheresis, White Blood Cell Reduction ApheresisUndergo leukapheresis | Procedure or surgery | Treatment (fludarabine, cyclophosphamide, CD83 CAR T-cells) |
| Lumbar PunctureAlso: LP, Spinal TapUndergo lumbar puncture | Procedure or surgery | Treatment (fludarabine, cyclophosphamide, CD83 CAR T-cells) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure)Undergo PET | Procedure or surgery | Treatment (fludarabine, cyclophosphamide, CD83 CAR T-cells) |
| Questionnaire AdministrationAncillary studies | Other | Treatment (fludarabine, cyclophosphamide, CD83 CAR T-cells) |
Primary outcome
Incidence of dose-limiting toxicity (DLT)
Time frame: Up to 28 days
Will be defined as any adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) version (v)5. Cytokine release syndrome(CRS)/immune effector cell-associated neurotoxicity syndrome will be graded according to American Society for Transplantation and Cellular Therapy (ASTCT) Consensus Guidelines. The DLTs will be summarized by dose level using frequencies and relative frequencies. Will employ the Bayesian optimal interval design to find the maximal tolerated dose (MTD). The target DLT rate for the MTD is = 0.33.
10 secondary outcomes
Objective response
Time frame: At 28 days and 1 year
Overall survival
Time frame: From treatment initiation until death due to any cause or last follow-up, assessed up to 1 year
Progression-free survival
Time frame: From treatment initiation until disease progression/relapse, death due to any cause, subsequent treatment (censored), or last follow-up, assessed up to 1 year
Hematologic recovery
Time frame: At 28 days
Time to hematologic recovery
Time frame: From treatment initiation until hematologic recovery or last follow-up, assessed up to 1 year
Acute graft-versus-host disease (GVHD)
Time frame: Up to 6 weeks
Time to GVHD
Time frame: From treatment initiation until grade II-IV GVHD, 6 weeks post infusion, or last follow-up, assessed up to 1 year
Treatment-related adverse events
Time frame: Up to 12 months
Time to treatment related adverse event
Time frame: From treatment initiation until a treatment related adverse event, 12 months post infusion, or last follow-up, assessed up to 1 year
Number of peripheral blood chimeric antigen receptor (CAR) T cells
Time frame: Up to 1 year
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 24 Sep 2026.
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Hematopoietic/Lymphoid Cancer, Accelerated Phase Chronic Myelogenous Leukemia
Active, not recruitingPhase 1
TAK-243 in Treating Patients With Relapsed or Refractory Acute Myeloid Leukemia or Myelodysplastic Syndromes With Increased Blasts
Myelodysplastic Syndrome With Excess Blasts, Recurrent Acute Myeloid Leukemia
RecruitingPhase 1
Clinical Trial of WBC100 Capsule in Relapsed/Refractory Acute Myeloid Leukemia
AML (Acute Myelogenous Leukemia, Relapsed Acute Myelogenous Leukemia
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.
Chelsea Peterson, DO principal investigator
Roswell Park Cancer Institute
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 Autologous Anti-CD83 CAR T-cells, Biospecimen Collection and Chest Radiography in people with Recurrent Acute Myeloid Leukemia and Refractory Acute Myeloid Leukemia, run by Roswell Park Cancer Institute 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 15 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose-limiting toxicity (DLT) (time frame: Up to 28 days). 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 Sep 2026.