LeukemiaPhase 1NCT03684889
CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma
A Phase 1 study testing SCRI-huCAR19v1 and SCRI-huCAR19v2 in people with Leukemia and Lymphoma, run by Seattle Children's Hospital at 2 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 fully human chimeric antigen receptor (CAR). Read more about this study
- Who is it for?
- Ages 1 year to 30 years
- What is being tested?
- SCRI-huCAR19v1 and SCRI-huCAR19v2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Nov 2018to Dec 2036
- 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 1 year to 30 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male and female subjects age ≥ 1 and ≤ 30 years
- First 2 enrolled subjects: age ≥ 18 and ≤ 30 years
- Disease requirements:
- Phase 1: Evidence of refractory or recurrent CD19+ leukemia or lymphoma following previous CAR T cell immunotherapy
- Phase 2: Evidence of refractory or recurrent CD19+ leukemia or lymphoma
- Able to tolerate apheresis, or has sufficient existing apheresis product or T cells for manufacturing investigational product
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- 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
- ≥ 7 days post last chemotherapy and biologic therapy, with the exception of intrathecal chemotherapy and maintenance chemotherapy
- No prior virotherapy
- ≥ 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
- 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
- Presence of primary immunodeficiency syndrome
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- 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 patient from undergoing treatment under this protocol
Trial locations and contacts
2 sites in 1 country.
United States2 sites
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)-06: A Phase 1/2 Study of CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ 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 fully human chimeric antigen receptor (CAR). The CAR used in this study can recognize CD19, a protein expressed on the surface of leukemia and lymphoma cells. The fully human CAR used in this study may help protect against rejection of the CAR T cells, which in turn could lead to lasting protection against return of the leukemia or lymphoma. The phase 1 part of this study will determine the safety 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-huCAR19v1, SCRI-huCAR19v2
- Keywords
- CAR T cell, CD19, pediatric, young adults
- 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-huCAR19v1Biological
1:1 mixture of CD4:CD8 autologous T cells lentivirally transduced to express a second generation 4-1BB-ζ human CD19-specific CAR and Her2tG
SCRI-huCAR19v2Biological
Mixture of CD4:CD8 autologous T cells lentivirally transduced to express a second generation 4-1BB-ζ human CD19-specific CAR and Her2tG
| Study group | Role | What they receive |
|---|---|---|
| SCRI-huCAR19v2 | Experimental | Patients will receive SCRI-huCAR19v2 in either Phase 1 or Phase II Receives: Biological: SCRI-huCAR19v2 |
| SCRI-huCAR19v1 - [CLOSED] | Experimental | Patients will receive SCRI-huCAR19v1 in either Phase 1 or Phase II. As of 02/13/2020 this study cohort is permanently closed. Receives: Biological: SCRI-huCAR19v1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The adverse events associated with CAR T cell product infusions will be assessed
The type, frequency, severity, and duration of adverse events will be summarized
Measured: 30 days
The leukemia response to SCRI-huCAR19 in subjects with relapsed or refractory CD19+ leukemia will be assessed
Response will be defined by standard bone marrow assessment and standard response criteria
Measured: 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start28 Nov 2018
- Primary completion8 Feb 2021
- Study completionDec 2036 (estimated)
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT03684889
- Sponsor's protocol ID
- PLAT-06
- Status last verified
- Oct 2026
- First submitted
- 17 Sep 2018
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-06: A Phase 1/2 Study of CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma
- ClinicalTrials.gov ID
- NCT03684889
- Acronym / sponsor ID
- PLAT-06
- Keywords
- CAR T cell, CD19, pediatric, young adults
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Study start
- 28 Nov 2018 (actual)
- Primary completion
- 8 Feb 2021 (actual)
- Study completion
- Dec 2036 (estimated)
- First posted
- 26 Sep 2018 (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 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 fully human chimeric antigen receptor (CAR). The CAR used in this study can recognize CD19, a protein expressed on the surface of leukemia and lymphoma cells. The fully human CAR used in this study may help protect against rejection of the CAR T cells, which in turn could lead to lasting protection against return of the leukemia or lymphoma. The phase 1 part of this study will determine the safety 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCRI-huCAR19v2 | Experimental | Biological: SCRI-huCAR19v2Patients will receive SCRI-huCAR19v2 in either Phase 1 or Phase II |
| SCRI-huCAR19v1 - [CLOSED] | Experimental | Biological: SCRI-huCAR19v1Patients will receive SCRI-huCAR19v1 in either Phase 1 or Phase II. As of 02/13/2020 this study cohort is permanently closed. |
Who may qualify
- Ages
- 1 year to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (19 listed)
- Male and female subjects age ≥ 1 and ≤ 30 years
- First 2 enrolled subjects: age ≥ 18 and ≤ 30 years
- Disease requirements:
- Able to tolerate apheresis, or has sufficient existing apheresis product or T cells for manufacturing investigational product
- Life expectancy ≥ 8 weeks
Key exclusion criteria (10 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
- 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
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-huCAR19v11:1 mixture of CD4:CD8 autologous T cells lentivirally transduced to express a second generation 4-1BB-ζ human CD19-specific CAR and Her2tG | Biological | SCRI-huCAR19v1 - [CLOSED] |
| SCRI-huCAR19v2Mixture of CD4:CD8 autologous T cells lentivirally transduced to express a second generation 4-1BB-ζ human CD19-specific CAR and Her2tG | Biological | SCRI-huCAR19v2 |
Primary outcome
The adverse events associated with 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 leukemia response to SCRI-huCAR19 in subjects with relapsed or refractory CD19+ leukemia will be assessed
Time frame: 63 days
Response will be defined by standard bone marrow assessment and standard response criteria
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 13 Oct 2026.
- 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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing SCRI-huCAR19v1 and SCRI-huCAR19v2 in people with Leukemia and Lymphoma, run by Seattle Children's Hospital at 2 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 19 inclusion and 10 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 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 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 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 13 Oct 2026.