Status:
WITHDRAWN
CD19.CAR-multiVSTs for Patients With CD19+ B-ALL or NHL Undergoing Related Allogeneic HSCT (CARMA)
Lead Sponsor:
Baylor College of Medicine
Collaborating Sponsors:
The Methodist Hospital Research Institute
Center for Cell and Gene Therapy, Baylor College of Medicine
Conditions:
Non-hodgkin Lymphoma
Acute Lymphoblastic Leukemia
Eligibility:
All Genders
1-75 years
Phase:
PHASE1
Brief Summary
This study is for patients that are having a bone marrow or stem cell transplant for either a type of cancer of the blood called Leukemia or a cancer of the lymph nodes called Non-Hodgkin's Lymphoma (...
Detailed Description
First, a donor gave us blood to make CD19 chimeric receptor multivirus specific T cells in the laboratory. These cells are grown and frozen for the patient. To make these special T cells, they are fir...
Eligibility Criteria
Inclusion
- Diagnosis of CD19+ B-ALL or NHL undergoing related allogeneic HSCT, with no evidence of disease post-HSCT (Group A) OR minimal residual disease (MRD) at time of HSCT OR relapse post-HSCT (Group B).
- Morphologic relapse (for Group B) will be defined by accepted definitions in Section 5.6 of the full protocol, and measured by PCR positivity, specific cytogenetic abnormalities, an abnormal population on flow cytometry or increased blasts on bone marrow biopsy or in the peripheral blood.
- MRD will be defined as detection in blood or marrow of any of the following (at time of transplant or on post-transplant evaluation): a) Any leukemia specific marker (such as t(9:22) or t(4:11)) documented in the patient's leukemia cells pre-transplant on a post-transplant evaluation b) An immune globulin rearrangement known to be a disease marker for this patient c) A leukemia specific phenotype at a level of \> 0.01%95, 96 d) Mixed donor chimerism.
- Age ≤ 75 years old
- Patients with life expectancy ≥ 12 weeks
- Patients with a Karnofsky/Lansky score ≥ 60
- Related Donor approved for stem cell transplant
- Patient or parent/guardian capable of providing informed consent
- Patients with bilirubin less than or equal to 2x upper limit of normal
- AST less than or equal to 3x upper limit of normal
- Creatinine ≤2x upper limit of normal for age
- Hemoglobin \>7.0 (can be a transfused value)
- Pulse oximetry of \>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 stem cell donor-derived CD19-CAR transduced multi-virus-specific cytotoxic T lymphocytes with 15% expression of CD19-CAR determined by flow-cytometry and \<10% cytotoxicity against patient or donor-derived (or other family member-derived) PHA blasts.
Exclusion
- Severe intercurrent infection: Patients with a concurrent bacterial infection must be receiving definitive therapy and have no signs of progressing infection for 72 hours prior to enrollment. For fungal infections patients must be receiving definitive systemic antifungal therapy and have no signs of progressing infection for 1 week prior to enrollment. Progressing infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing 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 at a dose of \>0.5mg/kg prednisone equivalent.
- CNS abnormalities: Presence of CNS-3 disease defined as detectable cerebrospinal blast cells in a sample of CSF with ≥ 5 WBCs per mm3; History or presence of any CNS disorder such as a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
- Patients who have received donor lymphocyte infusion (DLI) within 28 days.
Key Trial Info
Start Date :
June 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2040
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03768310
Start Date
June 1 2022
End Date
August 1 2040
Last Update
July 21 2022
Active Locations (2)
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1
Houston Methodist Hosptial
Houston, Texas, United States, 77030
2
Texas Children's Hospital
Houston, Texas, United States, 77030