Chemotherapy Refractory Adult Myeloid Leukemia Clinical Trial
— CART33Official title:
Clinical Study of Chimeric CD(Cluster of Differentiation)33 Antigen Receptor-modified T Cells in Relapsed and/or Chemotherapy Refractory Acute Myeloid Leukemias
RATIONALE: Placing a tumor antigen chimeric receptor that has been created in the laboratory
into patient autologous or donor-derived T cells may make the body build immune response to
kill cancer cells.
PURPOSE: This clinical trial is to study genetically engineered lymphocyte therapy in
treating patients with CD33 positive acute myeloid leukemias that is relapsed (after stem
cell transplantation or intensive chemotherapy) or refractory to further chemotherapy.
| Status | Recruiting |
| Enrollment | 10 |
| Est. completion date | April 2017 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 5 Years to 90 Years |
| Eligibility |
Inclusion Criteria: - Male and female subjects with CD33+ acute myeloid leukemia in patients with no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to < 2 year survival) with currently available therapies will be enrolled - CD33+ acute myeloid leukemia CR can not be achieved after at least 2 prior combination chemotherapy regimens. AML in CR(complete remission)2 or CR3 and not eligible for allogeneic SCT because of age, comorbid disease, or lack of available family member or unrelated donor. Less than 1 year between last chemotherapy and progression (i.e. most recent progression free interval < 1 year). Relapsed after prior autologous or allogenic SCT. AML patients with relapsed or residual disease after at least 1 prior therapy and not eligible for allogeneic SCT. Residual disease after primary therapy and not eligible for autologous SCT - Expected survival > 12 weeks - Creatinine < 2.5 mg/dl - ALT(alanine aminotransferase)/AST (aspartate aminotransferase)< 3x normal - Bilirubin < 2.0 mg/dl - Any relapse after prior SCT will make patient eligible regardless of other prior therapy - Adequate venous access for apheresis, and no other contraindications for leukapheresis - Voluntary informed consent is given Exclusion Criteria: - Pregnant or lactating women - The safety of this therapy on unborn children is not known - Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion - Uncontrolled active infection - Active hepatitis B or hepatitis C infection - Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary - Previously treatment with any gene therapy products - Feasibility assessment during screening demonstrates < 30% transduction of target lymphocytes, or insufficient expansion (< 5-fold) in response to CD3/CD137 costimulation - Any uncontrolled active medical disorder that would preclude participation as outlined - HIV infection |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital, Hematological Department, Affiliated Hospital of Changzhi Medical College | Beijing | Beijing |
| Lead Sponsor | Collaborator |
|---|---|
| Chinese PLA General Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | in vivo existence of CART33 | 1 year | Yes | |
| Primary | Occurrence of study related adverse events | defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment | Until week 24 | Yes |
| Secondary | Anti-leukemia responses to CART-33 cell infusions | up to 24 weeks | Yes |