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New treatment option for Recurrent Acute Myeloid Leukemia
Official title Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06871410
What this study is testing
What is Autologous Anti-CD83 CAR T-cells?
Autologous Anti-CD83 CAR T-cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent acute myeloid leukemia.
Also referred to as Autologous Anti-CD83 CAR T Cells; Autologous Anti-CD83 CAR-T Cells.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- 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...
- Patients requiring agents or any treatments other than hydroxyurea, single agent cytarbine,hypomethylating agents with or without ventoclax and/or...
- Ongoing uncontrolled serious infection, pulmonary disease or psycho/social concerns.
See the full eligibility criteria
- 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).
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- Ongoing uncontrolled serious infection, pulmonary disease or psycho/social concerns.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Buffalo, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Buffalo, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.