Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Autologous Anti-CD83 CAR T-cells · 1 trial · 2 indications
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| Name | Type | Description |
|---|---|---|
| Autologous Anti-CD83 CAR T-cells | DRUG | Given IV |
| Biospecimen Collection | PROCEDURE | Undergo bone marrow aspiration blood sample collection |
| Chest Radiography | PROCEDURE | Undergo chest x-ray |
| Computed Tomography | PROCEDURE | Undergo CT |
| Cyclophosphamide | DRUG | Given IV |
| Echocardiography | PROCEDURE | Undergo ECHO |
| Fludarabine Phosphate | DRUG | Given IV |
| Hydroxyurea | DRUG | Given hydroxyurea |
| Leukapheresis | PROCEDURE | Undergo leukapheresis |
| Lumbar Puncture | PROCEDURE | Undergo lumbar puncture |
| Positron Emission Tomography | PROCEDURE | Undergo PET |
| Questionnaire Administration | OTHER | Ancillary studies |
Inclusion 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 di...
Autologous Anti-CD83 CAR T-cells is an investigational cell therapy being developed for the treatment of recurrent acute myeloid leukemia. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities. The therapy is designed for patients with relapsed or refractory disease.
Autologous Anti-CD83 CAR T-cells targets the CD83 antigen, which is expressed on certain cells. The therapy uses genetically engineered T cells that are modified to recognize and attack cells presenting this target. This approach is being studied in the context of acute myeloid leukemia.
Autologous Anti-CD83 CAR T-cells is being developed by United Therapeutics Corporation, a company publicly traded under the ticker symbol UTHR. The company is conducting clinical research to evaluate the safety and efficacy of this investigational therapy in patients with recurrent acute myeloid leukemia.
Autologous Anti-CD83 CAR T-cells is currently in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by the FDA or other regulatory bodies. The ongoing Phase 1 trial is actively recruiting participants to assess the treatment in patients with relapsed or refractory acute myeloid leukemia.
Autologous Anti-CD83 CAR T-cells is being evaluated in a single Phase 1 clinical trial registered as NCT06871410. This study, titled 'Genetically Engineered Cells (CD83 CAR T Cells) for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia,' is recruiting 26 participants in the United States. The trial is open to adults aged 18 years and older.
Yes, Autologous Anti-CD83 CAR T-cells is also referred to as CD83 CAR T cells in clinical trial documentation. The investigational therapy involves genetically engineered cells that are designed to target the CD83 antigen. This naming is used interchangeably in the context of the ongoing Phase 1 study for acute myeloid leukemia.