Genetically Engineered Cells (Autologous Anti-CD7-CAR-CD28zeta T-cells) for the Treatment of Recurrent T-cell Malignancies

Inclusion Criteria

• PROCUREMENT INCLUSION CRITERIA: Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma ([T-NHL], including angioimmunoblastic T-cell lymphoma [AITL], enteropathy-associated T-cell lymphoma [EATL], monomorphic epitheliotropic intestinal T-cell lymphoma [MEITL], peripheral T-cell lymphoma [PTCL] not otherwise specified [NOS], anaplastic large cell lymphoma [ALCL], adult T-cell leukemia/lymphoma, T cell prolymphocytic leukemia with symptomatic disease, extranodal NK/T cell lymphoma, mycosis fungoides/ Sezary syndrome stage IIB or higher) AND * Suitable for allogeneic hematopoietic stem cell transplant (HSCT) * With a suitable donor identified by a Foundation for the Accreditation of Cellular Therapy (FACT) accredited transplant center * Willing to proceed to transplant if the CD7 CAR treatment induces complete remission and the patient/donor remain suitable candidates ** Using National Marrow Donor Program (NMDP) donor assessment criteria, suitability is defined as “during the search process, a donor is medically fit to proceed to the next step whether high-resolution or confirmatory human leukocyte antigen (HLA) testing OR donor work-up.” Documentation of suitability (including above criteria) will be confirmed by the investigator prior to treatment *** For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated
• PROCUREMENT INCLUSION CRITERIA: CD7-positive tumor (>= 20% CD7 positive blasts by flow cytometry or immunohistochemistry [tissue] assessed by a Clinical Laboratory Improvement Act [CLIA] certified Flow Cytometry/Pathology laboratory)
• PROCUREMENT INCLUSION CRITERIA: Age =< 75 years old. NOTE: The first three (3) patients treated on the study must be adults (>= 18 years [yrs] of age)
• PROCUREMENT INCLUSION CRITERIA: Hemoglobin (Hgb) >= 7.0 g/dL (can be transfused)
• PROCUREMENT INCLUSION CRITERIA: Life expectancy greater than 12 weeks
• PROCUREMENT INCLUSION CRITERIA: If pheresis required to collect blood: * Creatinine (Cr) < 1.5 upper limit normal * Aspartate aminotransferase (AST) < 5 x upper limit normal * Prothrombin time (PT) and activated partial thromboplastin time (APTT) < 1.5 x upper limit normal
• PROCUREMENT INCLUSION CRITERIA: Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent
• TREATMENT INCLUSION CRITERIA: Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma ([T-NHL], including angioimmunoblastic T-cell lymphoma [AITL], enteropathy-associated T-cell lymphoma [EATL], monomorphic epitheliotropic intestinal T-cell lymphoma [MEITL], Peripheral T-cell lymphoma [PTCL] not otherwise specified [NOS], anaplastic large cell lymphoma [ALCL], adult T-cell leukemia/lymphoma, T cell prolymphocytic leukemia with symptomatic disease, extranodal NK/T cell lymphoma, mycosis fungoides/ Sezary syndrome stage IIB or higher) AND * Suitable for allogeneic hematopoietic stem cell transplant (HSCT) * With a suitable donor identified by a FACT accredited transplant center * Willing to proceed to transplant if the CD7 CAR treatment induces complete remission and the patient/donor remain suitable candidates ** Using NMDP donor assessment criteria, suitability is defined as “during the search process, a donor is medically fit to proceed to the next step whether high-resolution or confirmatory HLA testing OR donor work-up.” Documentation of suitability (including above criteria) will be confirmed by the investigator prior to treatment *** For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated
• TREATMENT INCLUSION CRITERIA: CD7-positive tumor (>= 20% CD7+ blasts or tumor cells by flow cytometry or immunohistochemistry (tissue) assessed in a CLIA certified Flow Cytometry/Pathology laboratory
• TREATMENT INCLUSION CRITERIA: Age =< 75 years old. NOTE: The first three (3) patients treated on the study must be adults (>= 18 yrs of age)
• TREATMENT INCLUSION CRITERIA: Bilirubin less than 3 times the upper limit of normal
• TREATMENT INCLUSION CRITERIA: AST less than 5 times the upper limit of normal
• TREATMENT INCLUSION CRITERIA: Estimated glomerular filtration rate (GFR) >= 60 mL/min
• TREATMENT INCLUSION CRITERIA: Pulse oximetry of > 90% on room air
• TREATMENT INCLUSION CRITERIA: Karnofsky or Lansky score of >= 60%
• TREATMENT INCLUSION CRITERIA: Recovered from acute toxic effects of prior chemotherapy at least one week before entering this study
• TREATMENT INCLUSION CRITERIA: Available autologous activated peripheral blood T cell products released by QA
• TREATMENT INCLUSION CRITERIA: Life expectancy of greater than 8 weeks
• TREATMENT INCLUSION CRITERIA: Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom
• TREATMENT INCLUSION CRITERIA: Informed consent explained to, understood by, and signed by patient/guardian. Patient/guardian given copy of informed consent

Exclusion Criteria

• PROCUREMENT EXCULSION CRITERIA: Active infection requiring antibiotics
• PROCUREMENT EXCULSION CRITERIA: Active infection with human immunodeficiency virus (HIV)
• PROCUREMENT EXCULSION CRITERIA: History of other cancer (except non-melanoma skin cancer or in situ breast cancer or cervix cancer) unless the tumor was successfully treated with curative intent at least 2 years before trial entry
• TREATMENT EXCLUSION CRITERIA: Currently receiving any investigational agents or having received any tumor vaccines within the previous 6 weeks
• TREATMENT EXCLUSION CRITERIA: History of hypersensitivity reactions to murine protein-containing products
• TREATMENT EXCLUSION CRITERIA: Pregnant or lactating
• TREATMENT EXCLUSION CRITERIA: Tumor in a location where enlargement could cause airway obstruction (per investigator discretion)
• TREATMENT EXCLUSION CRITERIA: Active infection with HIV
• TREATMENT EXCLUSION CRITERIA: Clinically significant viral infection or uncontrolled viral reactivation of Epstein-Barr virus (EBV), cytomegalovirus (CMV), adenovirus (Adv), BK-virus, or human herpes virus (HHV-6)
• TREATMENT EXCLUSION CRITERIA: Any of the following cardiac criteria: Atrial fibrillation/flutter; Myocardial infarction within the last 12 months; Prolonged quart (QT) syndrome or secondary prolonged QT, per investigator discretion. Cardiac echocardiography with confirmation of absence of these conditions on echocardiogram within 12 months of treatment: Left ventricular systolic function (LVSF) < 30% or left ventricular ejection fraction (LVEF) < 50%; or clinically significant pericardial effusion. Cardiac dysfunction New York Heart Association (NYHA) III or IV
• TREATMENT EXCLUSION CRITERIA: Central nervous system (CNS) abnormalities: Presence of CNS-3 disease defined as detectable cerebrospinal blast cells in a sample of cerebrospinal fluid (CSF) with >= 5 white blood cells (WBCs) per mm^3 (unless negative by the Steinherz/Bleyer algorithm); presence of any CNS disorder such as an uncontrolled seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement