Status:
ACTIVE_NOT_RECRUITING
Multi-virus CTLs Expressing CD19 Chimeric Receptors, CD19 Positive Malignancies Post SCT, MULTIPRAT
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Acute Lymphoblastic Leukemia (ALL)
Chronic Lymphocytic Leukemia (CLL)
Eligibility:
All Genders
Phase:
PHASE1
Brief Summary
Subjects are having a bone marrow or SCT for either a type of cancer of the blood called Leukemia or a cancer of the lymph nodes called non- Hodgkin's Lymphoma. Although a transplant can cure leukemia...
Detailed Description
The donor gave us blood to make CD19 chimeric receptor trivirus specific T cells in the laboratory. These cells were grown and frozen for the subject. To make these special T cells they are grown with...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Any patient regardless of sex or age with CD19+ B-ALL undergoing allogeneic HSCT (Group A)
- OR Any patient regardless of sex or age with CD19+ B-CLL or NHL undergoing allogeneic HSCT (Group B).
- AND
- With minimal residual disease (MRD) or relapse post-HSCT (for the phase I dose escalation)
- OR
- With no evidence of ALL or CLL/NHL post-HSCT (to be included in the expansion cohort
- Patients with life expectancy greater than or equal to 6 weeks
- Patients with a Karnofsky/Lansky score greater than or equal to 50
- Donor HIV negative
- Patient or parent/guardian capable of providing informed consent
- Patients with bilirubin 2x normal or less, AST 3x normal or less, creatinine less than or equal to 2x normal for age and Hgb greater than 8.0
- Pulse oximetry of greater than 90% on room air
- Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the CTL infusion. The male partner should use a condom.
- Available allogeneic CD19CAR transduced tri-virus-specific cytotoxic T lymphocytes with greater than or equal to15% expression of CD19CAR determined by flow-cytometry and greater than 10% killing of one or more viral antigen pulsed targets in a cytotoxicity assay at an effector:target ratio of 20:1.\*
- Patients should have been off other investigational antiviral or antitumor therapy for one month prior to entry in this study.
- Note: Cell dose is based on total cell numbers and not individual antivirus or antileukemic cell numbers.
- EXCLUSION CRITERIA:
- Severe intercurrent infection
- Evidence of graft versus host disease \>grade II
- Pregnant or lactating
- History of hypersensitivity reactions to murine protein-containing products.
- Currently taking corticosteroids for therapy of GVHD.
Exclusion
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2031
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT00840853
Start Date
April 1 2009
End Date
April 1 2031
Last Update
July 9 2025
Active Locations (2)
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1
Houston Methodist Hospital
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030