LeukemiaPhase 1PLAT-04NCT03244306
A Phase 1 Study of CD22-CAR TCell Immunotherapy for CD22+ Leukemia and Lymphoma
A Phase 1 study testing Patient-derived CD22-specific CAR T-cells also expressing an EGFRt in people with Leukemia, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 26 years
- Conditions the study is for
- Leukemia
- What is being tested?
- Patient-derived CD22-specific CAR T-cells also expressing an EGFRt
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2017to 17 Apr 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 26 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 22Show fewer
- 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
Who cannot join
- Presence of active clinically significant CNS dysfunction
- Pregnant or breastfeeding
- Unable to tolerate apheresis procedure, including placement of temporary apheresis line if required
- Presence of active malignancy other than CD22+ leukemia or lymphoma
- Presence of active severe infection
- Presence of any concurrent medical condition that would prevent the patient from undergoing protocol-based therapy
- Presence of primary immunodeficiency/bone marrow failure syndrome
- Unwilling to participate in 15-year follow-up period that is required if CAR T cell therapy is administered
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: 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
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.
- Conditions
- Leukemia
- Being tested
- Patient-derived CD22-specific CAR T-cells also expressing an EGFRt
- Keywords
- leukemia, CD 22, CAR T cell, pediatric, young adult, chimeric antigen receptor
- Medical subject headings
- Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-derived CD22-specific CAR T-cells also expressing an EGFRtBiological
Patient-derived CD22-specific chimeric antigen receptor T-cells expressing an EGFRt
| Study group | Role | What they receive |
|---|---|---|
| Autologous CD22-specific CAR T-cells expressing EGFRt | Experimental | Not described Receives: Biological: Patient-derived CD22-specific CAR T-cells also expressing an EGFRt |
What is being measured
The primary outcome is the main question the study is designed to answer.
The adverse events associated with one or multiple CAR T-cell product infusions will be assessed
The type, frequency, severity, and duration of adverse events will be summarized
Measured: 30 days
The number of successfully and unsuccessfully manufactured and infused CAR T-cell products will be assessed
Proportion of products successfully manufactured and infused
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2017
- Study start27 Jul 2017
- Primary completion14 Nov 2018
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Colleen Annesley, Seattle Children's Hospital
- Investigators
- Corinne Summers, MD, Study chair, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03244306
- Sponsor's protocol ID
- PLAT-04
- Acronym
- PLAT-04
- Status last verified
- Jun 2026
- First submitted
- 3 Aug 2017
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03244306
- Acronym / sponsor ID
- PLAT-04 / PLAT-04
- Conditions
- Leukemia
- Keywords
- leukemia, CD 22, CAR T cell, pediatric, young adult, chimeric antigen receptor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 9 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous CD22-specific CAR T-cells expressing EGFRt | Experimental | Biological: Patient-derived CD22-specific CAR T-cells also expressing an EGFRt |
Who may qualify
- Ages
- 1 year to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (22 listed)
- 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):
- 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.
Key exclusion criteria (8 listed)
- Presence of active clinically significant CNS dysfunction
- Pregnant or breastfeeding
- Unable to tolerate apheresis procedure, including placement of temporary apheresis line if required
- Presence of active malignancy other than CD22+ leukemia or lymphoma
- Presence of active severe infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient-derived CD22-specific CAR T-cells also expressing an EGFRtPatient-derived CD22-specific chimeric antigen receptor T-cells expressing an EGFRt | Biological | Autologous CD22-specific CAR T-cells expressing EGFRt |
Primary outcome
The adverse events associated with one or multiple CAR T-cell product infusions will be assessed
Time frame: 30 days
The type, frequency, severity, and duration of adverse events will be summarized
The number of successfully and unsuccessfully manufactured and infused CAR T-cell products will be assessed
Time frame: 28 days
Proportion of products successfully manufactured and infused
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Summers, MD study chair
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Patient-derived CD22-specific CAR T-cells also expressing an EGFRt in people with Leukemia, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The adverse events associated with one or multiple CAR T-cell product infusions will be assessed (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.