NCT03244306CompletedPhase 1
A Phase 1 Study of CD22-CAR TCell Immunotherapy for CD22+ Leukemia and Lymphoma
Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-04: A Phase 1 Feasibility and Safety Study of CD22-CAR T Cell Immunotherapy for CD22+ Leukemia and Lymphoma
Source: ClinicalTrials.gov · Last updated 8 Jun 2026
Brief summary (registry, in English)
Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and some patients who relapse following CD19 directed therapy relapse with CD19 negative leukemia. For this reason, the investigators are attempting to use T-cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR) to CD22, a different protein from CD19, expressed on the surface of the leukemic cell in patients with CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through the recognition of CD22, a protein expressed on the surface of the leukemic cell in patients with CD22+ leukemia. This is a Phase 1 study designed to determine the safety and feasibility of the CAR+ T - cells and the feasibility of making enough to treat patients with CD22+ leukemia.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 4 (actual)
- First submitted
- 3 Aug 2017
- Start date
- 27 Jul 2017
- Primary completion date
- 14 Nov 2018
- Lead sponsor
- Seattle Children's Hospital
- Diseases
- Childhood cancers
- NCT number
- NCT03244306
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 4
- From 27 Jul 2017 to the primary completion date, 14 Nov 2018
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of any concurrent medical condition that would prevent the patient from undergoing protocol-based therapy
- Unwilling to participate in 15-year follow-up period that is required if CAR T cell therapy is administered
Other illness
- Presence of active malignancy other than CD22+ leukemia or lymphoma
- Presence of active severe infection
- Presence of primary immunodeficiency/bone marrow failure syndrome
Other
- Presence of active clinically significant CNS dysfunction
- Pregnant or breastfeeding
- Unable to tolerate apheresis procedure, including placement of temporary apheresis line if required
Who the study is looking for
- First 3 subjects: male and female subjects age ≥ 18 years and \< 27 years
- Subsequent subjects: 12 months of age and \<27 years of age at the time of study enrollment
- Disease status (one of the following):
- If post-allogeneic hematopoetic cell transplant (HCT): confirmed CD22+ leukemia recurrence, defined as ≥0.01% disease
- If Relapse/Refractory status with no prior history of allogeneic HCT, one of:
- 2nd or grater marrow relapse, with or without extramedullary disease
- 1st marrow relapse at end of 1st month of re-induction with marrow having ≥0.01% blasts by morphology and/or MPF
- Primary Refractory, defined as \>5% blasts by multi-parameter flow after ≥2 separate induction regimens
- Subject has indication for HCT but is ineligible, inclusive of persistent minimal residual disease
- CD22+ Lymphoma refractory or relapsed with no known curative therapies available
- Asymptomatic from CNS involvement, if present, and have a reasonable expectation that disease burden can be controlled in the interval between enrollment and T-cell infusion. Subjects with significant neurologic deterioration will not be eligible for T-cell infusion until stabilized.
- Free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks.
- Lansky or Karnofsky performance score of ≥50
- Life expectancy of \>8 weeks
- Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy
- ≥7 days post last chemotherapy administration (excluding intrathecal or maintenance chemotherapy)
- ≥7 days post last systemic corticosteroid administration
- No prior virotherapy
- Adequate organ function
- Adequate laboratory values
- Patients of childbearing/fathering potential must agree to use highly effective contraception
- Signed a written consent
Age in the registry: 1 year to 26 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Seattle Children's Hospital Coordinator of this site? Confirm its status | Seattle | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.