Actively Recruiting
Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) as a Bridge to Allogeneic Stem Cell Transplant
Led by Huda Salman · Updated on 2026-01-22
30
Participants Needed
4
Research Sites
980 weeks
Total Duration
On this page
Sponsors
H
Huda Salman
Lead Sponsor
I
iCell Gene Therapeutics
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is designed as a single arm open label traditional Phase I, 3+3, study of CD4-redirected chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory AML. The study will evaluate safety in this patient population and also the presence of efficacy signal described by elimination of residual disease to qualify patients for stem cell transplant.
CONDITIONS
Official Title
Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) as a Bridge to Allogeneic Stem Cell Transplant
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12 years or older at informed consent
- Ability to provide written informed consent and HIPAA authorization
- Diagnosis of CD4 positive AML that failed first-line treatments such as intensive induction or hypomethylation plus venetoclax
- If second-line FDA-approved treatments are available, must also have failed those before enrolling
- Creatinine clearance greater than 60 ml/min or clinically acceptable
- ALT and AST liver enzymes less than three times the upper limit of normal
- Bilirubin less than two times the upper limit of normal
- Pulmonary function test with DLCO of at least 60% if done within 6 months
- Echocardiogram with ejection fraction of 50% or higher
- Adequate venous access for leukapheresis
- Confirmed bone marrow donor for transplant post CD4CAR treatment if eligible
You will not qualify if you...
- AML that is CD4 negative
- Pregnant or breastfeeding women
- Uncontrolled active infections needing systemic treatment
- Active hepatitis B or C infection not controlled by antiviral therapy
- Use of systemic glucocorticoids above replacement doses or steroid dependency unless safely tapered
- Previous treatment with any gene therapy products
- Uncontrolled active medical disorders preventing safe participation
- HIV infection
- Receipt of live vaccines within 30 days before experimental treatment
- Active autoimmune diseases requiring systemic treatment in the last year
- History of mental disorders or substance abuse affecting compliance
- Active malignancy unrelated to AML requiring therapy in the last 3 years or not in remission
- Participation in another investigational drug study with experimental treatment within 6 months
- Ineligibility for conditioning chemotherapy due to organ dysfunction or major health changes
- Evidence of active infection or fever (unless due to underlying disease) at time of CD4CAR infusion
- Inadequate organ function or recent corticosteroid use not meeting study criteria at infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
2
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202
Actively Recruiting
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Cristina Roach, RN
CONTACT
H
Huda Salman, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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