Pilot Study of Redirected Autologous T Cells Engineered to Contain Humanized Anti-CD19 in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma Previously Treated With Cell Therapy
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Pennsylvania
Age
1–24
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male and female subjects with documented CD19+ B cell malignancies and no available curative treatment options (such as autologous or allogeneic SCT) who have limited prognosis (several months to \<2 year survival) with currently available therapies will be enrolled:
1. Eligible diseases: CD19+ leukemia or lymphoma. In general, these will be patients with:
1. partial response or no response to prior cell therapy
2. relapsed after prior cell therapy
3. demonstrated B cell recovery suggesting loss of engineered cells.
3. Documented CD19 expression (after previous B cell directed cell therapy, if applicable)
4. Age 1 to 24 years
5. Expected survival \> 12 weeks
6. Creatinine \< 2.5 mg/dl and less than 2.5x normal for age
7. Bilirubin \<2.0 mg/dl
8. Adequate pulmonary function defined as \< Grade 3 hypoxia
9. Adequate cardiac function defined as LVSF ≥ 28% confirmed by ECHO
10. Adequate performance status (Lansky or Karnofsky score ≥50)
1. Have no active GVHD and require no immunosuppression
2. Are more than 4 months from transplant (6 months at infusion)
13. For those patients who require leukapheresis for T cell collection (i.e. no previously collected product exists), adequate venous access for apheresis or eligible for appropriate catheter placement, and no other contraindications for leukapheresis.
14. Voluntary informed consent is given.
You may not be if
1. Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
2. Uncontrolled active infection.
3. Active hepatitis B or hepatitis C infection.
4. Concurrent use of systemic steroids at the time of cell infusion or cell collection, or a condition, in the treating physician's opinion, that is likely to require steroid therapy during collection or after infusion. Steroids for disease treatment at times other than cell collection or at the time of infusion are permitted. Use of physiologic replacement hydrocortisone or inhaled steroids is permitted as well.
5. Presence of grade 2-4 acute or extensive chronic GVHD.
6. Under treatment for GVHD.
7. CNS3 disease that is progressive on therapy, or with CNS parenchymal lesions that might increase the risk of CNS toxicity
8. Any uncontrolled active medical disorder that would preclude participation as outlined.
9. HIV infection
Clareo Health | Pilot Study of Redirected Autologous T Cells Engineered to Contain Humanized Anti-CD19 in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma Previously Treated With Cell Therapy
