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Phase 1/2 Study of Donor-Derived Anti-CD33 Chimeric Antigen Receptor Expressing T Cells (VCAR33) in Patients with Relapsed or Refractory Acute Myeloid Leukemia After Allogeneic Hematopoietic Cell Transplantation
Cancer Categories
Hematologic (Blood Cancers)
Karmanos Trial ID
2023-016
NCT ID
NCT05984199
Age Group
Adult
Scope
National
Phase
Phase I
Includes initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients.
Phase I/II
Principal Investigator
Abhinav
Deol, M.D.
Oncology - Hematology, Oncology - Medical
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Objective:
Primary Objectives:
To determine the safety and maximum tolerated dose (MTD) of VCAR33 in patients with relapsed or refractory acute myeloid leukemia (r/rAML) after allogeneic hematopoietic cell transplantation (alloHCT).
Secondary Objectives:
To further evaluate the safety and toxicity of VCAR33.
To determine the efficacy of VCAR33 in patients with r/rAML after alloHCT.
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Eligibility
Locations
Applicable Disease Site
Therapies | Drugs | Devices
Eligibility
Eligibility
Inclusion Criteria:
Patients aged ≥18 years
Patients must have CD33+ AML in relapse or refractory after alloHCT
Patients must be a recipient of an 8/8 (A, B, C, DRB1) HLA-matched related or unrelated donor alloHCT. Patients previously transplanted with VOR33 in the VBP101 study who have R/R AML may also be considered.
Disease status at the time of enrollment:
Arm A/Morphologic disease: Defined as ≥ 5% blasts (bone marrow) post-HCT
Arm B/MRD positive: < 5% blasts (bone marrow) with minimal residual disease of at least 0.1% CD33+ leukemia cells by flow cytometry
Performance status: ECOG 0 or 1
Patient must have adequate organ function as defined by:
Cardiac: Left ventricular ejection fraction (LVEF) ≥ 45% or fractional shortening ≥ 28%
Pulmonary: Baseline oxygen saturation > 92% on room air at rest
Hepatic: Total bilirubin < 3x institutional upper limit of normal (ULN) (except in case of patients with documented Gilbert's disease < 5x ULN) and aspartate aminotransferase (AST/SGOT)/alanine aminotransferase (ALT/SGPT) < 5x institutional ULN
Renal: Serum creatinine must be ≤ 1.2x institutional ULN or creatinine clearance ≥ 60 mL/min for patients with creatinine levels above institutional normal
Original alloHCT donor is available and willing to undergo apheresis
Exclusion Criteria:
Patients who have undergone more than one alloHCT
Patients who have undergone alloHCT with a mismatched unrelated donor, haploidentical donor, or with umbilical cord blood as the stem cell source
Patients who will be less than 100 days post-alloHCT at the time of VCAR33 infusion.
Patients with any history of Grade III or IV acute GVHD or severe chronic GVHD unless approved by the Sponsor Medical Monitor
Patients with evidence of ongoing active acute or chronic GVHD and are taking systemic immunosuppressive agents (> 10 mg daily of prednisone equivalent or other GVHD-directed treatment, including extracorporeal photopheresis). Patients with Grade 1 acute GVHD limited to the skin or mild chronic GVHD limited to the eyes, mouth, or skin controlled with only topical therapy are eligible.
Patients with active CNS disease. A lumbar puncture is not required to exclude CNS disease in the absence of clinical signs or symptoms suggesting CNS disease.
Patients with the following prior therapy:
DLI within 28 days prior to enrollment
Prior treatment with any CAR T cell therapy product
Patients with active or uncontrolled viral, bacterial, or fungal infection
Patients with a history of a human immunodeficiency virus (HIV) infection or acute or chronic active hepatitis B or C infection
Patients with a history of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g., cervix, bladder, or breast) unless disease free for at least 3 years after the last definitive therapy
Female patients of childbearing potential who are pregnant or breastfeeding
Locations
Locations
Karmanos Cancer Institute - Detroit Headquarters
4100 John R
Detroit, MI 48201
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Phone:
800-527-6266
Applicable Disease Site
Applicable Disease Site
Leukemia, other
Therapies, Drugs, Devices
Therapies | Drugs | Devices
Therapies
Cellular Therapy, Chemotherapy
Drugs
Cyclophosphamide; Fludarabine Phosphate; VCAR33ALLO
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