Actively Recruiting
PLAT-08: A Study Of SC-DARIC33 CAR T Cells In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AML
Led by Seattle Children's Hospital · Updated on 2025-12-23
18
Participants Needed
1
Research Sites
1000 weeks
Total Duration
On this page
Sponsors
S
Seattle Children's Hospital
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
PLAT-08: A Study Of SC-DARIC33 CAR T Cells In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 30 years or younger; the first three enrolled subjects must be 18 years or older
- Diagnosed with CD33-positive AML by flow cytometry meeting specific relapse or refractory definitions
- Able to undergo apheresis or have sufficient existing apheresis product or T cells
- Life expectancy of at least 8 weeks
- Identified appropriate stem cell donor source
- Lansky performance status score of 50 or higher if under 16 years, or Karnofsky score of 50 or higher if 16 years or older
- Discontinued anticancer agents and radiotherapy and recovered from prior treatment toxicities as specified
- Adequate organ function including kidney, liver, heart, and lung parameters
- Laboratory values meeting required criteria including sufficient lymphocyte count and negative virology testing
- Agreement to use highly effective contraception if of childbearing or child-fathering potential
- Signed informed consent form
You will not qualify if you...
- Active malignancy other than acute myeloid leukemia
- History of symptomatic or ongoing central nervous system disease requiring medical intervention, except well-controlled non-febrile seizure disorder
- Symptomatic CNS AML involvement not controllable before the investigational treatment
- Active graft-versus-host disease or recent immunosuppressive therapy if previously transplanted
- Active severe infection or positive blood culture near enrollment
- Primary immunodeficiency syndrome
- Prior virotherapy treatment
- Pregnant or breastfeeding
- Unwillingness to consent to 15-year follow-up
- Any condition preventing treatment under the protocol in the investigator's opinion
- Inability to tolerate lymphodepleting regimen
- Contraindication to receiving rapamycin
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
A
Adam Lamble, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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