RecruitingPhase 1NCT05105152

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

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


Sponsor

Seattle Children's Hospital

Enrollment

18 participants

Start Date

Nov 29, 2021

Study Type

INTERVENTIONAL

Conditions

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 genetically modified to express a Dimerizing Agent Regulated Immunoreceptor Complex (DARIC).


Eligibility

Max Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study (PLAT-08) is testing a specially engineered CAR T-cell therapy called SC-DARIC33 — immune cells modified to seek and destroy leukemia cells carrying a marker called CD33 — in children, teenagers, and young adults with acute myeloid leukemia (AML) that has returned or stopped responding to treatment. **You may be eligible if...** - You are 30 years old or younger (first 3 participants must be 18+) - You have AML whose cancer cells express the CD33 marker (confirmed by lab testing) - Your AML has relapsed (come back after a bone marrow transplant, or within 6 months of diagnosis), or did not respond to 2 rounds of induction chemotherapy, or has relapsed a second time or more **You may NOT be eligible if...** - Your cancer cells do not express CD33 - You have serious organ dysfunction or active serious infections - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALSC-DARIC33

Infusion with SC-DARIC33 followed by intermittent oral rapamycin administration


Locations(1)

Seattle Children's Hospital

Seattle, Washington, United States

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NCT05105152


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