CD4CAR for CD4+ Leukemia and Lymphoma (NCT03829540) | Clinical Trial Compass
RecruitingPhase 1
CD4CAR for CD4+ Leukemia and Lymphoma
United States20 participantsStarted 2020-07-09
Plain-language summary
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
Who can participate
Age range12 Years
SexALL
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Inclusion 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
✓. No supplemental oxygen at rest Note: Pulmonary Function Test (PFT) only required per treating physician discretion
✓. Adequate cardiac function with EF of ≥50%
Exclusion criteria
✕. Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential (see definition below) must have a negative serum or urine pregnancy test prior to initiation of conditioning chemotherapy, per research sites' clinical policy.
✕. Uncontrolled active infection necessitating systemic therapy.
What they're measuring
1
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
✕. Active hepatitis B or hepatitis C infection. Active hepatitis C is defined as the hepatitis C antibody is positive while quantitative HCV RNA results exceed the lower detection limit.
✕. Concurrent use of systemic glucocorticoids in greater than replacement doses (unless as a part of a standard of care salvage therapy or conditioning protocol), or steroid dependency defined in rheumatological and pulmonary diseases as uninterrupted corticosteroid intake for more than a year at a dosage of 0.3 mg/kg/day or greater, and where the underlying disease worsens on temporary stoppage of steroid therapy, with symptoms of steroids withdrawal (eg, lethargy, headache, weakness, pseudorheumatism, emotional disturbances, etc) precipitated by the temporary stoppage.
✕. Hydrocortisone 25mg/day or less
✕. Prednisone 10mg/day or less
✕. Dexamethasone 4mg or less Note: Recent or current use of inhaled glucocorticoids is not exclusionary, as this route pertains extremely minimal systemic penetration.
✕. Any uncontrolled active medical disorder that would preclude participation as outlined in the opinion of the treating investigator and/or study chair