← Back to Search

CAR T-cell Therapy

Treatment for Acute Myeloid Leukemia

Phase 1

Waitlist Available

Led By Huda Salman, MD, PhD

Research Sponsored by Huda Salman

Eligibility Criteria Checklist

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

Must have

Adequate venous access for apheresis and no other contraindications for leukapheresis

Diagnosis of AML that is CD4+ and is recurrent or refractory to first line standard of care treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through day 30

Awards & highlights

Study Summary

This trial is testing a new treatment for patients with relapsed or refractory AML (a type of leukemia). The goal is to see if the treatment is safe and if it can help eliminate the

Who is the study for?

This trial is for individuals with Acute Myeloid Leukemia (AML) that has come back or hasn't responded to treatment. It's aimed at those who might be candidates for a stem cell transplant if this therapy reduces their disease.Check my eligibility

What is being tested?

The study tests CD4CAR, a type of engineered T-cell therapy designed to target AML cells. This Phase I trial will assess the safety and potential effectiveness of CD4CAR as a preparatory step before a stem cell transplant.See study design

What are the potential side effects?

Potential side effects may include immune system reactions, infusion-related symptoms, and effects from altered T-cells targeting the body's own cells, but specific side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I can undergo apheresis with no issues.

Select...

My AML is resistant or has come back after initial treatment.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through day 30

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through day 30

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through day 30 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

1. Dose finding: Maximum tolerated dose (MTD) is defined as one dose level lower than the Dose Limiting Toxicity (DLT) of the CD4CAR in AML.

3. Determine the influence of CD4CAR on T regs

Determine the influence of CD4CAR on myeloiod derived suppressor cells, MDSCs

+1 more

Secondary outcome measures

Describe disease response.

Determine mLSCs frequency before and after the CD4CAR infusion

Quantification of CD4CAR associated cytokines

Trial Design

1Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Redirected autologous T cells transduced with the anti-CD4 lentiviral vector (referred to as "CD4CAR" cells)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Huda SalmanLead Sponsor

2 Previous Clinical Trials

50 Total Patients Enrolled

Huda Salman, MD, PhDPrincipal InvestigatorIndiana University

1 Previous Clinical Trials

30 Total Patients Enrolled

Frequently Asked Questions

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

Has this therapy received the official endorsement of the Food and Drug Administration (FDA)?

"Based on the classification of this trial as Phase 1, our team at Power estimates the safety of this treatment to be a 1. This indicates that there is limited data available regarding its safety and efficacy."

Answered by AI

Are new participants still eligible to enroll in this ongoing clinical trial?

"According to the information provided on clinicaltrials.gov, this specific trial is not currently in search of participants. The posting date for this trial was January 1st, 2024 and it was last updated on December 27th, 2023. However, there are currently a total of 1487 other ongoing clinical trials actively seeking eligible participants at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) as a Bridge to Allogeneic Stem Cell Transplant

Huda Salman 2024. "Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) as a Bridge to Allogeneic Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06197672.