LeukemiaPhase 1NCT03330691
A Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia
A Phase 1 study testing Patient-derived CD19- and CD22 specific CAR in people with Leukemia and Lymphoma, run by Seattle Children's Hospital at 5 sites in 2 countries.
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 Up to 30 years
- What is being tested?
- Patient-derived CD19- and CD22 specific CAR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 3 Nov 2017to 3 Mar 2035
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 Up to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- First 2 subjects: male and female subjects age ≥18 and < 27 years (as of 2/16/18 the first 2 subjects were enrolled and treated); subsequent subjects <31 years.
- Diagnosis of CD19+22+ leukemia
- Disease status:
- If post allogeneic HCT: Confirmed CD19+CD22+ leukemia recurrence defined as at least 0.01% disease following allogeneic HCT
- If relapse/refractory status with no prior history of allogeneic HCT, one of the following:
- Second or greater marrow relapse, with or without extramedullary disease
Show all 21Show fewer
- First marrow relapse at end of first month or re-induction with marrow having at least 0.01 % blasts by morphology and/or MPF
- Primary refractory as defined as greater than 5% blasts by multi-parameter flow after at least 2 separate induction regimens.
- Subject has indication for HCT but has been deemed ineligible, inclusive of persistent MRD prior to HCT
- Asymptomatic from CNS involvement, if present, and in the opinion of the Principal Investigator with 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 prior to enrollment
- Lansky or Karnofsky performance score of at least 50
- Life expectancy of at least 8 weeks
- Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy
- At least 7 days post last chemotherapy administration (excluding intrathecal maintenance chemotherapy)
- At least 7 das post last systemic corticosteroids administration (unless physiologic replacement dosing)
- No prior genetically modified cell therapy that is still detectable or virotherapy
- Adequate organ function
- Adequate laboratory values
- Willing to participate in long-term follow-up for up to 15 years, if enrolled in the study and receive T cell infusion
- Patients of childbearing/fathering potential must agree to use highly effective contraception from the time of initial T cell infusion through 12 months following the last T cell infusion
Who cannot join
- Presence of active clinically significant CNS dysfunction
- Pregnant or breast-feeding
- Unable to tolerate apheresis procedure
- Presence of active malignancy other than CD19+CD22+ leukemia
- Presence of active severe infection
- Presence of any concurrent medical condition that, in the opinion of the Principal Investigator, would prevent the patient from undergoing protocol-specified therapy
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Hospital Los Angeles
Los Angeles, California, 90027
Seattle Children's Hospital
Seattle, Washington, 98105
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Canada1 site
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, V6H 3V4
About this study
Official title: Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-05: A Phase 1 Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia
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 two chimeric antigen receptors (CARs). One is to recognize CD19 and the other is to recognize CD22, both of which are proteins expressed on the surface of the leukemic cell in patients with CD19+CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through recognition of CD19 and CD22. This is a phase 1 study designed to determine the safety of the CAR+ T-cells and the feasibility of making enough to treat patients with CD19+CD22+ leukemia.
- Being tested
- Patient-derived CD19- and CD22 specific CAR
- Keywords
- CD19, CD22, CAR T-cell
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-derived CD19- and CD22 specific CARBiological
Patient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt
| Study group | Role | What they receive |
|---|---|---|
| Patient-derived CD19- and CD22 specific CAR v1 | Experimental | Patient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt Receives: Biological: Patient-derived CD19- and CD22 specific CAR |
| Patient-derived CD19- and CD22 specific CAR v2 | Experimental | Patient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt Receives: Biological: Patient-derived CD19- and CD22 specific CAR |
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
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 posted6 Nov 2017
- Study start3 Nov 2017
- Primary completion13 Sep 2023
- Study completion3 Mar 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 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
- Colleen Annesley, MD, Study chair, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03330691
- Sponsor's protocol ID
- PLAT-05
- Status last verified
- Dec 2025
- First submitted
- 31 Oct 2017
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Singh N. Modified T cells as therapeutic agents. Hematology Am Soc Hematol Educ Program. 2021 Dec 10;2021(1):296-302. doi: 10.1182/hematology.2021000262.
PubMed 34889384Johnson AJ, Wei J, Rosser JM, Kunkele A, Chang CA, Reid AN, Jensen MC. Rationally Designed Transgene-Encoded Cell-Surface Polypeptide Tag for Multiplexed Programming of CAR T-cell Synthetic Outputs. Cancer Immunol Res. 2021 Sep;9(9):1047-1060. doi: 10.1158/2326-6066.CIR-20-0470. Epub 2021 Jul 9.
PubMed 34244298
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-05: A Phase 1 Feasibility and Safety Study of Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy for CD19+CD22+ Leukemia
- ClinicalTrials.gov ID
- NCT03330691
- Acronym / sponsor ID
- PLAT-05
- Keywords
- CD19, CD22, CAR T-cell
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 3 Nov 2017 (actual)
- Primary completion
- 13 Sep 2023 (actual)
- Study completion
- 3 Mar 2035 (estimated)
- First posted
- 6 Nov 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 two chimeric antigen receptors (CARs). One is to recognize CD19 and the other is to recognize CD22, both of which are proteins expressed on the surface of the leukemic cell in patients with CD19+CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through recognition of CD19 and CD22. This is a phase 1 study designed to determine the safety of the CAR+ T-cells and the feasibility of making enough to treat patients with CD19+CD22+ leukemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient-derived CD19- and CD22 specific CAR v1 | Experimental | Biological: Patient-derived CD19- and CD22 specific CARPatient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt |
| Patient-derived CD19- and CD22 specific CAR v2 | Experimental | Biological: Patient-derived CD19- and CD22 specific CARPatient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (21 listed)
- First 2 subjects: male and female subjects age ≥18 and < 27 years (as of 2/16/18 the first 2 subjects were enrolled and treated); subsequent subjects <31 years.
- Diagnosis of CD19+22+ leukemia
- Disease status:
- Asymptomatic from CNS involvement, if present, and in the opinion of the Principal Investigator with 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 prior to enrollment
Key exclusion criteria (6 listed)
- Presence of active clinically significant CNS dysfunction
- Pregnant or breast-feeding
- Unable to tolerate apheresis procedure
- Presence of active malignancy other than CD19+CD22+ leukemia
- 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 CD19- and CD22 specific CARPatient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt | Biological | Patient-derived CD19- and CD22 specific CAR v1, Patient-derived CD19- and CD22 specific CAR v2 |
Primary outcome
The adverse events associated with one or multiple CAR T-cell product infusions will be assessed
Time frame: 30 days
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Derived from this study: PubMed 34889384Singh N. Modified T cells as therapeutic agents. Hematology Am Soc Hematol Educ Program. 2021 Dec 10;2021(1):296-302. doi: 10.1182/hematology.2021000262.
- Derived from this study: PubMed 34244298Johnson AJ, Wei J, Rosser JM, Kunkele A, Chang CA, Reid AN, Jensen MC. Rationally Designed Transgene-Encoded Cell-Surface Polypeptide Tag for Multiplexed Programming of CAR T-cell Synthetic Outputs. Cancer Immunol Res. 2021 Sep;9(9):1047-1060. doi: 10.1158/2326-6066.CIR-20-0470. Epub 2021 Jul 9.
- Individual participant dataSharing planned: No
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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.
Colleen Annesley, MD study chair
Seattle Children's Hospital
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Patient-derived CD19- and CD22 specific CAR in people with Leukemia and Lymphoma, run by Seattle Children's Hospital at 5 sites in 2 countries.
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 21 inclusion and 6 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: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
On the ClinicalTrials.gov record for NCT03330691, which also lists 2 linked publications.
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 15 Dec 2025.