Actively Recruiting
A Phase I, Multicenter Study of CD4-Directed Chimeric Antigen Receptor Engineered T-cells (CD4CAR) in Patients With Relapsed or Refractory CD4+ Hematological Malignancies
Led by Huda Salman · Updated on 2026-04-27
20
Participants Needed
6
Research Sites
782 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
Researchers are evaluating the safety and feasibility of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory CD4-positive T-cell leukemia and lymphoma. This Phase I, open-label, multicenter study focuses on patients who have not responded to prior treatments or have relapsed, aiming to establish a recommended dose and schedule of CD4CAR cells. The study is supported by the FDA OOPD and involves centers including Stony Brook and Indiana University. Participants will undergo a dose-escalation protocol where autologous CD4CAR T-cells are created from their blood cells collected by apheresis. After conditioning chemotherapy and confirmation of disease status, patients receive a single IV infusion of the engineered T-cells. The infusion lasts about 20 minutes, with doses prepared and frozen approximately 3 to 4 weeks after cell collection. The study uses a traditional 3+3 design to find the maximum tolerated dose while monitoring for dose-limiting toxicities. Throughout the study, patients will have frequent blood tests to monitor cytokine levels, presence of CD4CAR cells, and immune responses. Tumor burden is assessed starting on day 6 post-infusion and regularly thereafter for up to 6 months, with quarterly follow-ups for two years. After this period, participants may continue in a long-term follow-up study for up to 15 years to monitor survival, relapse, and any new health issues. Safety monitoring includes checking for infections and organ function, and decisions about further transplants are made by the treating physician.
CONDITIONS
Brief Title
CD4CAR for CD4+ Leukemia and Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must voluntarily sign informed consent and agree to comply with study procedures
- Age 12 years or older
- Diagnosed with CD4-positive T-cell hematologic malignancies, relapsed or refractory, including prior transplant patients without remaining donor cells
- Creatinine clearance greater than 60 ml/min or non clinically significant as per investigator
- Liver enzymes (ALT/AST) less than 3 times upper limit of normal
- Bilirubin less than 2 times upper limit of normal
- No supplemental oxygen required at rest
- Adequate cardiac function with ejection fraction of 50% or higher
- Adequate venous access for apheresis and no contraindications for leukapheresis
You will not qualify if you...
- Pregnant or lactating women; negative pregnancy test required for women of reproductive potential
- Uncontrolled active infections needing systemic therapy
- Active hepatitis B or hepatitis C infections, with exceptions for treated and controlled cases
- Use of systemic glucocorticoids above replacement doses unless part of standard salvage or conditioning therapy
- Any uncontrolled active medical disorder that would prevent participation
- HIV infection
- Declining consent for treatment
- Receipt of live vaccines within 30 days before treatment; inactivated flu vaccine allowed
- Active autoimmune diseases requiring systemic treatment in the last 2 years, with some exceptions
- History of mental disorders or drug abuse affecting compliance
- Active malignancy unrelated to T-cell malignancy requiring therapy in last 3 years or not in remission, with some exceptions
- Treatment with investigational cell/gene therapy within 6 months
- Treatment with investigational anticancer agent within 14 days or 5 half-lives before study entry
- At time of CD4CAR infusion: supplemental oxygen requirement, uncontrolled cardiac arrhythmia, hypotension needing pressors, or positive blood cultures within 48 hours
- Requirement to use contraception and avoid conception during and 90 days after infusion for those of reproductive potential
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 to 4 weeks
Participants undergo apheresis to collect T cells for manufacturing CD4CAR cells. The collected cells are processed and prepared for infusion.
1 apheresis procedure and monitoring visits during manufacturing
Duration - Short period before infusion
Participants receive conditioning chemotherapy to prepare for CD4CAR cell infusion and help reduce tumor burden.
1 to 2 visits for chemotherapy administration
Duration - Single day
Participants receive a single intravenous infusion of CD4CAR T-cells targeting CD4-positive hematological malignancies.
1 infusion visit (approximately 20 minutes)
Duration - Up to 6 months
Participants are actively monitored for safety and treatment effects including blood tests for cytokines and CD4CAR cells, and tumor assessments.
Multiple visits on Days 0, 1, 3, 5, 7, 14, 28, 42 and weekly tumor assessments until Day 42, then monthly for 6 months
Duration - Up to 15 years
Participants have quarterly clinical evaluations for two years, followed by phone and questionnaire follow-up for up to 13 years to assess survival and late effects.
Quarterly visits for 2 years and twice-yearly phone follow-ups thereafter
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
H
Huda Salman, MD
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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