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CAR T-cell Therapy

CD33KO-HSPC followed by CART33 for Acute Myeloid Leukemia

Phase 1

Recruiting

Led By David Porter, MD

Research Sponsored by University of Pennsylvania

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

Study Summary

This trial aims to test a new treatment for Acute Myeloid Leukemia (AML). The treatment involves a combination of a modified stem cell transplant from a healthy donor and CAR T cells that

Who is the study for?

This trial is for adults over 18 with Acute Myeloid Leukemia (AML) that's hard to cure with existing treatments. Candidates must have a suitable stem cell donor, good kidney and liver function, no severe heart or lung issues, and can't be on systemic immunosuppression if they've had a transplant before.Check my eligibility

What is being tested?

The study tests a new AML treatment combining modified stem cell transplants from donors with CAR T-cell therapy. The CAR T-cells are designed to target leukemia cells without affecting the newly transplanted 'invisible' healthy blood cells.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site, flu-like symptoms, changes in blood pressure or heart rate, difficulty breathing, fatigue, fever, chills and risk of infection due to immune system suppression.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Manufacturing feasibility

Occurrence of dose-limiting toxicities related to CART-33

Occurrence of dose-limiting toxicities related to CD33KO-HSPC

Secondary outcome measures

Duration of Response (DOR)

Efficacy of CD33KO-HSPC

Efficacy of at least 1 dose of CART-33

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: CD33KO-HSPC followed by CART33Experimental Treatment1 Intervention

All subjects will receive CD33KO-HSPC, followed by 1-3 CART-33 infusions

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of PennsylvaniaLead Sponsor

2,005 Previous Clinical Trials

42,882,271 Total Patients Enrolled

David Porter, MDPrincipal InvestigatorUniversity of Pennsylvania

6 Previous Clinical Trials

111 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available vacancies for patient participation in this clinical trial?

"As per clinicaltrials.gov, this research project is actively in search of suitable candidates. The trial was first listed on 2/23/2024 and last modified on 3/5/2024."

Answered by AI

What is the risk level associated with CD33KO-HSPC followed by CART33 treatment for individuals?

"Our team at Power has assessed the safety of CD33KO-HSPC followed by CART33 to be a 1 on our scale. This rating is attributed to the early Phase 1 stage, indicating minimal available data supporting both safety and efficacy."

Answered by AI

What is the current total number of participants being recruited for this clinical study?

"Yes, as per clinicaltrials.gov records, this research study is currently in the recruitment phase. Initially listed on 2/23/2024 and most recently revised on 3/5/2024, the trial aims to enroll 16 participants at a single designated site."

Answered by AI

What is the primary objective of this medical study?

"The main focus during the 6-month span of this research is assessing the feasibility of production. Secondary objectives encompass gauging Overall Survival (OS) at both the 6 and 12-month marks, evaluating CD33KO-HSPC efficacy based on established benchmarks for hematopoietic engraftment, monitoring Progression-Free Survival (PFS) by tracking patient response sustainability post initial CART-33 infusion within a year, and determining median progression time from AML diagnosis to CART-33 administration."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

CD33KO-HSPC Infusion Followed by CART-33 Infusion(s) for Refractory/Relapsed AML

2024. "CD33KO-HSPC Infusion Followed by CART-33 Infusion(s) for Refractory/Relapsed AML". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05945849.

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