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Acute Myeloid LeukemiaPhase 1NCT05105152

PLAT-08: A Study Of SC-DARIC33 CAR T Cells In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AML

A Phase 1 study testing SC-DARIC33 in people with Acute Myeloid Leukemia and Acute Myeloid Leukemia Refractory, run by Seattle Children's Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

A phase 1, open-label, non-randomized study enrolling pediatric and young adult patients with relapsed or refractory CD33+ leukemia with and without prior history of allogeneic hematopoietic cell transplantation, to examine the safety and feasibility of administering an autologous T cell product that has been… Read more about this study

Who is it for?
Ages Up to 30 years
What is being tested?
SC-DARIC33
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
29 Nov 2021to 31 Jan 2041
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

  • Subject age ≤ 30 years. The first three enrolled subjects must be ≥ 18 years of age.
  • AML that expresses CD33 by flow cytometry and meets one of the below definitions:
  • For subjects who have previously received an allogeneic HCT, any evidence of AML re-emergence post HCT detectable by flow cytometry
  • First relapse of AML ≤ 6 months of initial diagnosis
  • First relapse of AML > 6 months after initial diagnosis, with MRD of >0.1% by flow cytometry (MPF) after at least one re-induction (single cycle) attempt
  • Second or greater relapse AML
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  • Refractory AML, defined as >1% leukemic cells determined by flow cytometry after 2 cycles of induction chemotherapy
  • Able to tolerate apheresis, or subject with sufficient existing apheresis product or T cells for manufacturing investigational product.
  • Life expectancy ≥ 8 weeks
  • Has an appropriate stem cell donor source identified
  • Lansky performance status score of ≥ 50 for subjects <16 years of age or Karnofsky score ≥ 50 for subjects ≥ 16 years. Subjects who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for purposes of assessing performance status
  • If a subject does not have a previously obtained apheresis product that is acceptable and available for manufacturing of DARIC T cells, the subject must discontinue all anticancer agents and radiotherapy and, in the opinion of the investigator, have fully recovered from significant acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy:
  • Chemotherapy and biologic agents: All chemotherapy and biologic therapy not specifically mentioned below must be discontinued ≥ 7 days prior to enrollment, with the exception of intrathecal chemotherapy for which there is not a required washout period b. Must be ≥ 30 days from last gemtuzumab ozogamicin dose. c. Steroid use: All corticosteroid therapy (unless physiologic replacement dosing) must be discontinued ≥ 7 days prior to enrollment d. Tyrosine Kinase Inhibitor (TKI) use: All TKIs must be discontinued ≥ 3 days prior to enrollment e. Hydroxyurea: must be discontinued ≥ 1 day prior to enrollment. f. Gene Modified cellular therapy: i. must be at least 30 days from most recent gene modified cell therapy infusion and document no evidence of modified cells in the peripheral blood OR ii. must be at least 60 days from most recent gene modified cell therapy
  • Adequate organ function as indicated by:
  • Renal: Serum creatinine ≤ 1.5 X the upper limit of normal (ULN)
  • Hepatic: Total bilirubin ≤ 3 times ULN for age OR conjugated bilirubin ≤ 2 mg/dL AND ALT (SGPT) ≤ 5 times ULN
  • Cardiac: Shortening fraction ≥ 28% OR ejection fraction ≥ 50% as measured by echocardiogram
  • Respiratory: Oxygen saturation ≥ 92% on room air without supplemental oxygen or mechanical ventilation
  • Laboratory values meet the following criteria:
  • Subjects requiring apheresis: Absolute Lymphocyte Count (ALC) ≥ 100 cells/uL b. Virology Testing negative within 3 months prior to enrollment, to include: i. HIV antigen \& antibody ii. Hepatitis B surface antigen iii. Hepatitis C antibody OR if positive, Hepatitis C PCR is negative
  • If subject is of childbearing or child-fathering potential, must agree to use highly effective contraception from the time of initial consent through 12 months following the infusion of investigational product on this trial.
  • Subject and/or legally authorized representative has signed the Informed Consent Form for this study

Who cannot join

  • Active malignancy other than acute myeloid leukemia
  • History of symptomatic non-AML CNS disease or ongoing symptomatic CNS disease requiring medical intervention, including paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injury, dementia, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder (subjects with non-febrile seizure disorder controlled on anti-epileptic medication and without seizure activity within 1 month are eligible).
  • CNS AML involvement that is symptomatic and in the opinion of the investigator, cannot be controlled during the interval between enrollment and DARIC T cell infusion
  • If history of allogeneic stem cell transplant: active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment
  • Presence of active severe infection, defined as:
  • positive blood culture within 48 hours of enrollment, OR ii. fever above 38.2° C, AND clinical signs of infection within 48 hours of enrollment
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  • 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 DARIC 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
  • Considered by the investigator to be unable to tolerate a lymphodepleting regimen
  • Subject has a contraindication to receiving rapamycin

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Adam Lamble, MD contact

206-986-2106

CBDCIntake@seattlechildrens.org

United States1 site, 1 recruiting

  • Seattle Children's Hospital

    Seattle, Washington, 98105

    Adam Lamble, MD, CBDCIntake@seattlechildrens.org

    Adam Lamble, MD

    Recruiting

Other trials in United States

About this study

Official title: Pediatric And Young Adult Leukemia Adoptive Therapy (PLAT)-08: A Phase 1 Study Of SC-DARIC33 In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AML

A phase 1, open-label, non-randomized study enrolling pediatric and young adult patients with relapsed or refractory CD33+ leukemia with and without prior history of allogeneic hematopoietic cell transplantation, to examine the safety and feasibility of administering an autologous T cell product that has been genetically modified to express a Dimerizing Agent Regulated Immunoreceptor Complex (DARIC).

Being tested
SC-DARIC33
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SC-DARIC33Biological

    Infusion with SC-DARIC33 followed by intermittent oral rapamycin administration

Study groups in NCT05105152
Study groupRoleWhat they receive
DARIC-33ExperimentalNot described
Receives: Biological: SC-DARIC33

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events associated with SC-DARIC33 cell product infusions will be assessed

    The type, frequency, severity, and duration of adverse events will be summarized

    Measured: 28 days post-infusion

  2. Ability to successfully manufacture SC-DARIC33

    Measure of the number of successfully manufactured SC-DARIC33 products

    Measured: 28 days

Secondary outcomes (1)

  1. Acute Myeloid Leukemia response to SC-DARIC in subjects with relapsed or refractory CD33+ myeloid leukemia will be assessed

    The efficacy of the SC-DARIC33 assessed based on the bone marrow aspirate testing following SC-DARIC infusion

    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.

  1. First posted3 Nov 2021
  2. Study start29 Nov 2021
  3. Primary completion28 Feb 2028 (estimated)
  4. Study completion31 Jan 2041 (estimated)

Resources

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
Model description
Phase I open-label, dose-finding study employing the Bayesian optimal interval (BOIN) design
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05105152
Sponsor's protocol ID
PLAT-08
Status last verified
Dec 2025
First submitted
7 Oct 2021
Last updated
23 Dec 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SC-DARIC33 in people with Acute Myeloid Leukemia and Acute Myeloid Leukemia Refractory, 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 13 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: looking for participants now, as of the sponsor's last update on 23 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 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?

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?

Contact Adam Lamble, MD (206-986-2106, CBDCIntake@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events associated with SC-DARIC33 cell product infusions will be assessed (time frame: 28 days post-infusion). 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 NCT05105152.

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 23 Dec 2025.

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