A Phase 1, Multicenter Study of CD4- Directed Chimeric Antigen Receptor Engineered T-Cells (CD4CAR) in Patients with Relapsed or Refractory T-Cell Leukemia and Lymphoma
|Principal Investigators:Salman, Huda||Current Status: OPEN TO ACCURAL|
|Phase: I||Protocol Type: Treatment|
|Coordinator: Munoz, Sebastian
|Sponsor Type: Institutional
Disease Group: Hematologic Malignancy, Hematology Oncology
Patients must voluntarily sign and date informed consent forms that state his or her willingness to comply with all study procedures and availability for the duration of the study.
Subjects with documented CD4+ hematologic malignancies. Male and female subjects with CD4+ T-cell malignancies with either relapsed or refractory disease (including those patients who have undergone a prior transplant and patients with an inadequate response after 4-6 cycles of standard chemotherapy)
Patients who present with CD4+ Leukemia. Either relapsed disease or minimal residual disease (MRD); any of the following are eligible:
For patients with CD4+ Lymphoma. Either relapsed or refractory disease; any of the following are eligible:
Age 18 years old or older
Creatinine clearance of > 60 ml/min
ALT/AST < 3 x ULN
Bilirubin < 2.0 mg/dL
Serum albumin of ≥ 3gms/dl
Pulmonary Function Test (PFT) with diffusing capacity of lung for carbon monoxide (DLCO) of ≥ 60%.
Adequate echocardiogram with ejection fraction (EF) of ≥50%
Adequate venous access for apheresis and no other contraindications for leukapheresis Eligibility for CD4CAR infusion
No evidence of an active or uncontrolled infection for at least 72 hours
If previous history of corticosteroid chemotherapy, subject must off all but adrenal replacement doses
Repeat baseline indicates presence of disease but not rapidly progressing disease.
Specific organ functional criteria for cardiac, renal, and liver function similar to initial inclusion are met. Tests such as echocardiogram and PFTs need not be repeated if within 6 weeks of initial assessment
Negative pregnancy testing (if applicable)