Actively Recruiting
CD4CAR for CD4+ Leukemia and Lymphoma
Led by Huda Salman · Updated on 2026-04-27
20
Participants Needed
6
Research Sites
1116 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 Phase I, 3x3, multicenter study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory T-cell leukemia and lymphoma. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells. Funding Source - FDA OOPD
CONDITIONS
Official Title
CD4CAR for CD4+ Leukemia and Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must voluntarily sign informed consent and be willing to comply with study procedures
- Age 12 years or older
- Diagnosed with CD4+ T cell hematologic malignancies with relapsed or refractory disease
- Creatinine clearance greater than 60 ml/min or clinically acceptable
- Liver enzymes 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 for the procedure
You will not qualify if you...
- Pregnant or lactating women
- Uncontrolled active infection requiring systemic therapy
- Active hepatitis B or C infection unless successfully treated and virus undetectable for 6 months
- Use of systemic glucocorticoids above replacement doses unless part of standard salvage therapy
- Any uncontrolled active medical disorder that would prevent participation
- HIV infection
- Refusal to consent for treatment
- Receipt of live vaccines within 30 days before treatment
- Active autoimmune diseases needing systemic treatment in last 2 years
- History of mental disorders or drug abuse affecting treatment compliance
- Active malignancy unrelated to T-cell cancer requiring therapy in last 3 years or not in remission
- Treatment with investigational cell/gene therapy in past 6 months
- Treatment with investigational anticancer agents within 14 days or 5 half-lives before study entry
- Requirement for supplemental oxygen or presence of progressive chest abnormalities at time of infusion
- New uncontrolled cardiac arrhythmia or hypotension needing pressors at time of infusion
- Positive blood cultures within 48 hours before T cell infusion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 6 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
Albert Einstein Health Network
New York, New York, United States, 10467
Actively Recruiting
5
Stony Brook Cancer Center
Stony Brook, New York, United States, 11794
Active, Not Recruiting
6
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
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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