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

ConditionsAcute Myeloid LeukemiaAcute Myeloid Leukemia RefractoryAcute Myeloid Leukemia, in Relapse
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 30
SponsorSeattle Children's Hospital

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject age ≤ 30 years. The first three enrolled subjects must be ≥ 18 years of age.

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • SC-DARIC33

    Biological/Vaccine

    Infusion with SC-DARIC33 followed by intermittent oral rapamycin administration

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: DARIC-33Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Time frame
28 days post-infusion
2

Ability to successfully manufacture SC-DARIC33

Measure of the number of successfully manufactured SC-DARIC33 products

Time frame
28 days

Secondary outcomes

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

Time frame
28 days post-infusion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seattle Children's Hospital

Lead sponsor

Regeneron Pharmaceuticals

Collaborator

Source ClinicalTrials.gov
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