Status:
UNKNOWN
Treatment of Relapsed and/or Chemotherapy Refractory CD33 Positive Acute Myeloid Leukemia by CART-33
Lead Sponsor:
Chinese PLA General Hospital
Conditions:
Relapsed Adult Myeloid Leukemia
Chemotherapy Refractory Adult Myeloid Leukemia
Eligibility:
All Genders
5-90 years
Phase:
PHASE1
PHASE2
Brief Summary
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 cel...
Detailed Description
PRIMARY OBJECTIVES: I. Determine the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD33 vector (referred to as CART-33 cells). II. Determine duration of in...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2017
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT01864902
Start Date
April 1 2013
End Date
April 1 2017
Last Update
January 28 2016
Active Locations (1)
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1
Biotherapeutic Department and Pediatrics Department of Chinese PLA General Hospital, Hematological Department, Affiliated Hospital of Changzhi Medical College
Beijing, Beijing Municipality, China, 100853