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CAR T-cell Therapy

SC-DARIC33 CAR T Cells for Acute Myeloid Leukemia

Phase 1
Recruiting
Research Sponsored by Seattle Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Performance status score of Lansky ≥ 50 for subjects <16 years of age or Karnofsky score ≥ 50 for subjects ≥ 16 years
AML that expresses CD33 by flow cytometry and meets specific criteria including relapse of AML, refractory AML, or evidence of AML re-emergence post HCT detectable by flow cytometry
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trial is testing a new treatment for leukemia that uses the patient's own genetically modified cells.

Who is the study for?
This trial is for pediatric and young adult patients up to 30 years old with relapsed or refractory CD33+ acute myeloid leukemia (AML). They must have adequate organ function, not be pregnant or breastfeeding, agree to use effective contraception, and be able to undergo apheresis. Those with active severe infections, other cancers, primary immunodeficiency syndrome, or who can't tolerate lymphodepleting regimens are excluded.Check my eligibility
What is being tested?
The study tests SC-DARIC33 CAR T cells in children and young adults with AML that's come back after treatment or hasn't responded at all. It's an early-phase trial assessing the safety of using genetically modified T cells designed to target cancerous cells expressing CD33.See study design
What are the potential side effects?
While specific side effects aren't listed here, CAR T cell therapies like SC-DARIC33 may cause symptoms such as fever, fatigue, headache, difficulty breathing, rapid heartbeat and low blood pressure. Some people might experience more serious issues affecting the brain or immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can do most activities but may need help, regardless of my age.
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My AML shows CD33 and has relapsed or is not responding to treatment.
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I can undergo apheresis or have enough T cells for treatment production.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability to successfully manufacture SC-DARIC33
Adverse events associated with SC-DARIC33 cell product infusions will be assessed
Secondary outcome measures
Acute Myeloid Leukemia response to SC-DARIC in subjects with relapsed or refractory CD33+ myeloid leukemia will be assessed

Trial Design

1Treatment groups
Experimental Treatment
Group I: DARIC-33Experimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Seattle Children's HospitalLead Sponsor
300 Previous Clinical Trials
5,216,809 Total Patients Enrolled
2seventy bioIndustry Sponsor
2 Previous Clinical Trials
122 Total Patients Enrolled

Media Library

SC-DARIC33 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05105152 — Phase 1
Acute Myeloid Leukemia Research Study Groups: DARIC-33
Acute Myeloid Leukemia Clinical Trial 2023: SC-DARIC33 Highlights & Side Effects. Trial Name: NCT05105152 — Phase 1
SC-DARIC33 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05105152 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What evidence exists to demonstrate that SC-DARIC33 is safe for people?

"This drug's safety rating is 1, as it has only been through the initial phase of testing with limited evidence to support its efficacy and security."

Answered by AI

Are any new participants being added to this study at present?

"Affirmative. Clinicaltrials.gov has data verifying that this trial began recruiting on November 29th 2021 and is still enrolling participants as of September 6th 2022, requiring 18 individuals from a solitary medical centre."

Answered by AI

What is the cap on volunteer enrollment in this medical research?

"Affirmative, clinicaltrials.gov states that this trail is still searching for suitable subjects. It was first uploaded on November 29th 2021 and most recently updated September 6th 2022. This research requires 18 individuals to be enrolled from one trial site."

Answered by AI
~8 spots leftby Feb 2026