Actively Recruiting
Chimeric Antigen Receptor T Cell Therapy Redirected to CD4 (CD4CAR)as a Second Line Treatment for Chronic Myelomonocytic Leukemia, CMML.
Led by Huda Salman · Updated on 2026-03-18
30
Participants Needed
4
Research Sites
1031 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-directed chimeric antigen receptor engineered T-cells (CD4CAR) in subjects with relapsed or refractory CMML. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells.
CONDITIONS
Official Title
Chimeric Antigen Receptor T Cell Therapy Redirected to CD4 (CD4CAR)as a Second Line Treatment for Chronic Myelomonocytic Leukemia, CMML.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older at the time of consent
- Able to provide written informed consent and HIPAA authorization
- Diagnosed with CD4-positive chronic myelomonocytic leukemia (CMML) that is relapsed or refractory to first-line treatment
- Creatinine clearance of 60 ml/min or higher (or judged non-significant by investigator)
- ALT and AST less than 3 times the upper limit of normal
- Bilirubin less than 2 times the upper limit of normal
- No need for supplemental oxygen at rest
- Adequate cardiac function with ejection fraction of 50% or higher
- Adequate venous access for leukapheresis and no contraindications to the procedure
You will not qualify if you...
- CMML that is CD4 negative
- Pregnant or breastfeeding women
- Uncontrolled active infection requiring systemic therapy
- Active hepatitis B or C infection, except treated and controlled cases as specified
- Use of systemic glucocorticoids above replacement doses or steroid dependency as defined
- Any uncontrolled active medical condition that prevents participation as judged by investigator
- HIV infection
- Receipt of live vaccines within 30 days before treatment; inactivated flu vaccine allowed
- Active autoimmune diseases needing systemic treatment in the past year, except specified exceptions
- History of mental disorders or drug abuse affecting treatment compliance
- Active malignancy unrelated to CMML needing recent therapy or not in remission, with some exceptions
- Treatment with investigational cell or gene therapy within past 6 months
- Treatment with investigational anticancer agents within 14 days or 5 half-lives before study entry
- Requirement for supplemental oxygen or progressive lung abnormalities at infusion time
- New uncontrolled cardiac arrhythmia
- Hypotension requiring pressor support
- Positive blood cultures within 48 hours before infusion
- Female participants of reproductive potential must have negative pregnancy test and agree to contraception during and after study as specified
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 33136
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
Albert Einstein Health Network
The Bronx, New York, United States, 10467
Not Yet Recruiting
4
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
C
Cristina Roach, RN
CONTACT
J
Jennifer Schwartz, 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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