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New treatment option for Acute Myeloid Leukemia
Official title PLAT-08: A Study Of SC-DARIC33 CAR T Cells In Pediatric And Young Adults With Relapsed Or Refractory CD33+ AML
ClinicalTrials.gov ID: NCT05105152
What this study is testing
What is SC-DARIC33?
SC-DARIC33 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 30
You may be able to join if
- Subject age ≤ 30 years. The first three enrolled people must be ≥ 18 years of age.
- AML that expresses CD33 by flow cytometry and meets one of the below definitions:
- For people 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)...
You likely can't join if
- 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...
- CNS AML involvement that is symptomatic and in the opinion of the investigator, cannot be controlled during the interval between enrollment and DARIC...
- If history of allogeneic stem cell transplant: active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks...
- Presence of active severe infection, defined as: i. positive blood culture within 48 hours of enrollment, OR ii. fever above 38.2° C, AND clinical...
- Primary immunodeficiency syndrome
See the full eligibility criteria
- Subject age ≤ 30 years. The first three enrolled people must be ≥ 18 years of age.
- AML that expresses CD33 by flow cytometry and meets one of the below definitions:
- For people 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
- 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 people \<16 years of age or Karnofsky score ≥ 50 for people ≥ 16 years. people who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered...
- 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...
- 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: a. people requiring apheresis: Absolute Lymphocyte Count (ALC) ≥ 100 cells/uL b. Virology Testing negative within 3 months prior to enrollment, to include: i. HIV antigen...
- 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...
- Subject and/or legally authorized representative has signed the Informed Consent Form for this study
- 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...
- 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: i. 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Seattle, Washington, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.