A Phase I, Multicenter Study of CD4- Directed Chimeric Antigen Receptor Engineered T-cells (CD4CAR) in Patients With Relapsed or Refractory CD4+ Hematological Malignancies
This study is designed as a single arm open label Phase I, 3x3, multicenter study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory T-cell leukemia and lymphoma. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells. Funding Source - FDA OOPD
⁃ In order to be eligible to participate in this study, an individual will be enrolled if they meet the following criteria:
• 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.
• Age 12 years old or older
• Subjects with any documented CD4+ T cell hematologic malignancies. Male and female subjects with CD4+ T-cell hematologic malignancies with either relapsed or refractory disease (including those patients who have undergone a prior transplant (if allogeneic, subjects are eligible if there are no remaining donor cells) and patients with an inadequate response after 4-6 cycles of standard chemotherapy) are eligible. Response criteria for each disease subset will be evaluated based on Standard of Care Guidelines.
• Creatinine clearance of \> 60 ml/min (or otherwise non clinically-significant, per study investigator)
• ALT/AST \< 3 x ULN
• Bilirubin \< 2 x ULN
• Pulmonary Function Test (PFT) with a DLCO of ≥ 60%.
• Adequate echocardiogram with EF of ≥50%
• Adequate venous access for apheresis and no other contraindications for leukapheresis