LeukemiaPhase 1/2NCT04571138
A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD22 for Relapsed/Refractory Leukemia or Lymphoma
A Phase 1/2 study testing SCRI-CAR22v2 in people with Leukemia and Lymphoma, run by Seattle Children's Hospital at 4 sites in United States.
Trial summary
Patients with relapsed or refractory leukemia or lymphoma are often refractory to further chemotherapy. In this study, the investigators will attempt to use T cells obtained directly from the patient, which can be genetically engineered to express a chimeric antigen receptor (CAR). Read more about this study
- Who is it for?
- Ages Up to 30 years
- What is being tested?
- SCRI-CAR22v2
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 4 sitesUnited States
- Study dates
- 25 Sep 2020to Feb 2040
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male and female subjects aged ≤ 30 years. First 2 enrolled subjects: age ≥ 18 and ≤ 30 years
- Evidence of refractory or recurrent CD22+ leukemia or lymphoma
- Able to tolerate apheresis, or subject with sufficient existing apheresis product or T cells for manufacturing investigational product.
- Life expectancy ≥ 8 weeks
- Lansky or Karnofsky, as applicable, score ≥ 50
- Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy, if the subject does not have a previously obtained apheresis product that is acceptable and available for manufacturing of CAR T cells
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- ≥ 7 days post last chemotherapy and biologic therapy, with the exception of intrathecal chemotherapy and maintenance chemotherapy
- ≥ 7 days post last corticosteroid therapy
- ≥ 3 days post Tyrosine Kinase Inhibitor (TKI) use
- ≥ 1 day post hydroxyurea
- 30 days post most recent CAR T cell infusion
- Adequate organ function
- Adequate laboratory values, including absolute lymphocyte count ≥ 100 cells/uL
- Subjects of childbearing or child-fathering potential must agree to use highly effective contraception from consent through 12 months following infusion of investigational product on trial
- Subject and/or legally authorized representative has signed the informed consent form for this study
Who cannot join
- Presence of active malignancy other than disease under study
- History of symptomatic CNS pathology or ongoing symptomatic CNS pathology
- CNS involvement of leukemia or lymphoma that is symptomatic and in the opinion of the investigator, cannot be controlled during the interval between enrollment and CAR T cell infusion
- Subjects with uniform expression of CD19 on their malignant cells who are eligible but have not attempted CD19 directed CAR T cell therapy
- For subjects having had a previous stem cell transplant: presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment
- Presence of active severe infection,
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- Presence of primary immunodeficiency syndrome
- Subject has received prior virotherapy
- Pregnant or breastfeeding
- Subject and/or legally authorized representative unwilling to provide consent/assent for participation in the 15-year follow-up period, required if CAR T cell therapy is administered
- Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Texas Children's Hospital
Houston, Texas, 77030
Riley Hospital for Children
Indianapolis, Indiana, 46202
Children's Hospital Los Angeles
Los Angeles, California, 90027
Seattle Children's Hospital
Seattle, Washington, 98105
About this study
Official title: Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-07: A Phase 1/2 Study of CD22-Specific CAR T Cells for CD22+ Leukemia or Lymphoma
Patients with relapsed or refractory leukemia or lymphoma are often refractory to further chemotherapy. In this study, the investigators will attempt to use T cells obtained directly from the patient, which can be genetically engineered to express a chimeric antigen receptor (CAR). The CAR used in this study can recognize CD22, a protein expressed on the surface of leukemia and lymphoma cells. The phase 1 part of this study will determine the safety and appropriate dose level of these CAR T cells, and the phase 2 part of the study will determine how effective this CAR T cell therapy is. Both patients who have never had prior CAR T cell therapy and those who have had prior CAR T cell therapy may be eligible to participate in this study.
- Being tested
- SCRI-CAR22v2
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCRI-CAR22v2Biological
Single infusion of SCRI-CAR22v2
| Study group | Role | What they receive |
|---|---|---|
| SCRI-CAR22v2 | Experimental | Patients will receive SCRI-CAR22v2 in either Phase I or Phase II Receives: Biological: SCRI-CAR22v2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicities
Number of participants who experienced an adverse event meeting the dose-limiting toxicity definition
Measured: 28 days post-infusion
The Ability to Successfully Manufacture SCRI-CAR22v2
Number of participants who have a releasable cell product generated
Measured: 28 days
The Leukemia Response to SCRI-CAR22v2 in Subjects With Relapsed or Refractory CD22+ Leukemia Will be Assessed
Number of participants with an MRD negative complete remission after initial CAR T cell infusion (by Day 28 post infusion assessment +/- 3 Days)
Measured: 28 days post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start25 Sep 2020
- Primary completion8 Aug 2025
- Study completionFeb 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 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
- NCT04571138
- Sponsor's protocol ID
- PLAT-07
- Status last verified
- Jul 2026
- First submitted
- 2 Sep 2020
- Last updated
- 11 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-07: A Phase 1/2 Study of CD22-Specific CAR T Cells for CD22+ Leukemia or Lymphoma
- ClinicalTrials.gov ID
- NCT04571138
- Acronym / sponsor ID
- PLAT-07
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 25 Sep 2020 (actual)
- Primary completion
- 8 Aug 2025 (actual)
- Study completion
- Feb 2040 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Posted 11 Sep 2026
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 or lymphoma are often refractory to further chemotherapy. In this study, the investigators will attempt to use T cells obtained directly from the patient, which can be genetically engineered to express a chimeric antigen receptor (CAR). The CAR used in this study can recognize CD22, a protein expressed on the surface of leukemia and lymphoma cells. The phase 1 part of this study will determine the safety and appropriate dose level of these CAR T cells, and the phase 2 part of the study will determine how effective this CAR T cell therapy is. Both patients who have never had prior CAR T cell therapy and those who have had prior CAR T cell therapy may be eligible to participate in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SCRI-CAR22v2 | Experimental | Biological: SCRI-CAR22v2Patients will receive SCRI-CAR22v2 in either Phase I or Phase II |
Who may qualify
- Ages
- Up to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (15 listed)
- Male and female subjects aged ≤ 30 years. First 2 enrolled subjects: age ≥ 18 and ≤ 30 years
- Evidence of refractory or recurrent CD22+ leukemia or lymphoma
- Able to tolerate apheresis, or subject with sufficient existing apheresis product or T cells for manufacturing investigational product.
- Life expectancy ≥ 8 weeks
- Lansky or Karnofsky, as applicable, score ≥ 50
Key exclusion criteria (11 listed)
- Presence of active malignancy other than disease under study
- History of symptomatic CNS pathology or ongoing symptomatic CNS pathology
- CNS involvement of leukemia or lymphoma that is symptomatic and in the opinion of the investigator, cannot be controlled during the interval between enrollment and CAR T cell infusion
- Subjects with uniform expression of CD19 on their malignant cells who are eligible but have not attempted CD19 directed CAR T cell therapy
- For subjects having had a previous stem cell transplant: presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment
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 |
|---|---|---|
| SCRI-CAR22v2Single infusion of SCRI-CAR22v2 | Biological | SCRI-CAR22v2 |
Primary outcome
Dose Limiting Toxicities
Time frame: 28 days post-infusion
Number of participants who experienced an adverse event meeting the dose-limiting toxicity definition
The Ability to Successfully Manufacture SCRI-CAR22v2
Time frame: 28 days
Number of participants who have a releasable cell product generated
The Leukemia Response to SCRI-CAR22v2 in Subjects With Relapsed or Refractory CD22+ Leukemia Will be Assessed
Time frame: 28 days post-infusion
Number of participants with an MRD negative complete remission after initial CAR T cell infusion (by Day 28 post infusion assessment +/- 3 Days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing SCRI-CAR22v2 in people with Leukemia and Lymphoma, run by Seattle Children's Hospital at 4 sites 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 15 inclusion and 11 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 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Dose Limiting Toxicities (time frame: 28 days post-infusion). The study lists 3 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 11 Sep 2026.