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

Part of paid clinical trials in Seattle, Washington.

Sponsor
Seattle Children's Hospital
Study ID
NCT05105152
Phase
PHASE1
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - 30 Years
Healthy Volunteers
Not accepted

Interventions

  • SC-DARIC33 — BIOLOGICAL
    Infusion with SC-DARIC33 followed by intermittent oral rapamycin administration

Study Details

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).

Key Dates

Start date
Nov 29, 2021
Status verified
Dec 2025
Primary completion
Feb 28, 2028
Completion
Jan 31, 2041

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: DARIC-33

Primary Outcome Measure

Adverse events associated with SC-DARIC33 cell product infusions will be assessed [ Time Frame: 28 days post-infusion ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Seattle Children's HospitalSeattleWashington98105
Adam Lamble, MD
Adam Lamble, MD (PRINCIPAL_INVESTIGATOR)

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