A Pediatric Trial of Genetically Modified Autologous T Cells Directed Against CD19 for Relapsed CD19+ Acute Lymphoblastic Leukemia
Running, not enrolling · Phase 1
Conditions studied: B Cell Leukemia
In brief
Patients with relapsed leukemia often develop resistance to chemotherapy. For this reason, we are attempting to use a patient's own T cells, which can be genetically modified to expresses a chimeric antigen receptor(CAR). The CAR enables the T cell to recognize and kill the leukemic cells though the recognition of CD19, a protein expressed on the surface of the majority of pediatric ALL. This is a phase I study designed to determine the maximum tolerated dose of the CAR+ T cells and define the toxicity of the treatment. As a secondary aim, we will be looking at the efficacy of the T cells on eradicating the patient's leukemic cells.
Key facts
- Study ID
- NCT01683279
- Run by
- Seattle Children's Hospital
- People needed
- 6
- Starts
- 2012-03-25
- Expected to finish
- 2030-01-07
- Last updated by the study team
- 2026-06-05
Who can join
Age: 1 and older, up to 26. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- CD19+ Leukemia in 1st marrow relapse with MRD at the end of 1st month of re-induction
- CD19+ Leukemia in 2nd or greater relapse
- CD19+ Leukemia with indication for HCT, but has contraindication
- Age between 1 and 26 years of age
- Karnofsky of >50 or Lansky >50
- Life Expectancy >12 weeks
- Able to tolerate a blood draw of 4-6mL/kg
- Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy
- absolute lymphocyte count of >/=750 cell/mm3 or >/=500 is >20kg
- creatinine clearance or radioisotope GFR >/= 70mL/min/1.73m2 OR normal serum creatinine based on age/gender
- total bilirubin </= 1.5x upper limit normal OR direct bilirubin </= 1.5mg/dl
- ALT </= 3x upper limit normal
- corrected QTc <450msec of ECG
- Shortening Fraction >28% by ECHO or Ejection Fraction >50% by MUGA
- Documented negative HIV, Hep B and Hep C
- Agree to long-term follow up for up to 15 years if they receive T cell infusion
You may not qualify if…
- Philadelphia Positive Leukemia
- Prior Allogeneic Stem Cell Transplant
- CNS 2 or 3
- prior cellular immunotherapy with chimeric antigen receptor modified T cells
- fully humanized antibodies within three half lives
- systemic corticosteroids within 7 days of enrollment
- requires supplemental oxygen or has a chest X-ray with an infectious process
- CNS pathology (seizure disorder, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder)
- Pregnant or breastfeeding women. Female participant of reproductive age must have a negative pregnancy test and agree to contraception for 1 year after T cell infusion.
- Active Malignancy other than CD19+ Leukemia
- Active severe infection defined as a positive blood culture within 48 hours of study enrollment or a fever >38.2C AND clinical signs of infection within 48 hours of study enrollment
- Patient has a concurrent medical condition, that in the opinion of the protocol PI or designee, would prevent the patient from undergoing protocol-based therapy.
- Trisomy 21
- Primary immunodeficiency/bone marrow failure syndrome
Where it is running
- Seattle Children's Hospital — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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