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CD4CAR for T-cell Leukemia and Lymphoma

This study is testing a new treatment called CD4CAR for people with T-cell leukemia and lymphoma that has returned or not responded to previous treatments. CD4CAR uses your own immune cells (T-cells) that are specially engineered to target and fight cancer cells. The main goal of this study is to see how safe CD4CAR is and if it's possible to give it to patients. We expect to treat about 15 patients aged 12 and older. This study is currently unclear regarding its recruitment status.

Study design
This is a single-arm, open-label study, meaning all participants receive the CD4CAR treatment and everyone knows what treatment is being given. It plans to enroll about 20 participants, with an expected 15 receiving treatment.
What's involved
You would first have your T-cells collected through a process called leukapheresis. Then, you would receive chemotherapy before getting the CD4CAR cells through an infusion.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be checked for treatment-related side effects for 18-24 months after receiving the CD4CAR cells.

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NCT03829540

CD4CAR for CD4+ Leukemia and Lymphoma

Recruiting
PHASE1Ages 12+InterventionalTreatment
Huda Salman
~20 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:CD4CAR

At a glance

Recruiting sites
5 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Measured over 18-24 months

Conditions

T-cell Lymphoma
T-cell Leukemia

Explore related trials

Leukemia, T-CellT-Cell Non-Hodgkin LymphomaCD4 Gene

Where it's being run

6 sites across 4 states
Indiana2
New York2
Florida1
Texas1

Study leadership

  • Huda Salman, MD · PRINCIPAL_INVESTIGATOR · Indiana University

Who to contact

Tara Haney, RN
[email protected]
317-2784184
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Condoms (male or female) with or without a spermicidal agent.
Diaphragm or cervical cap with spermicide
Intrauterine device (IUD)
Hormonal-based contraception Subjects who are not of reproductive potential (women who have been post-menopausal for at least 24 consecutive months or have undergone hysterectomy, salpingotomy, and/or bilateral oophorectomy or men who have documented azoospermia) are eligible without requiring the use of contraception. Acceptable documentation of sterilization, azoospermia, and menopause is specified next:
Physician report/letter
Operative report or other source documentation in the subject record (a laboratory report of azoospermia is required to document successful vasectomy)
Discharge summary
Laboratory report of azoospermia
Follicle stimulating hormone measurement elevated into the menopausal range

Exclusion

Subjects with a history of hepatitis B but have received antiviral therapy and have nondetectable viral DNA for 6 months prior to enrollment are eligible
Subjects seropositive for HBS antibodies due to hepatitis B virus vaccine with no signs or active infection (Negative HBs Ag, HBc and HBe Ags) are eligible
Subjects who had hepatitis C but have received antiviral therapy and show no detectable hepatitis C virus (HCV) viral RNA for 6 months are eligible
If hepatitis C antibody test is positive, then patients must be tested for the presence of antigen by reverse transcription-polymerase chain reaction (RT-PCR) and be hepatitis C virus ribonucleic acid (HCV RNA) negative. 4. Concurrent use of systemic glucocorticoids in greater than replacement doses (unless as a part of a standard of care salvage therapy or conditioning protocol), or steroid dependency defined in rheumatological and pulmonary diseases as uninterrupted corticosteroid intake for more than a year at a dosage of 0.3 mg/kg/day or greater, and where the underlying disease worsens on temporary stoppage of steroid therapy, with symptoms of steroids withdrawal (eg, lethargy, headache, weakness, pseudorheumatism, emotional disturbances, etc) precipitated by the temporary stoppage.

What this trial measures

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.018-24 months

    To assess the safety and feasibility of the chimeric antigen receptor T cells transduced with the anti-CD4 lentiviral vector (referred to as "CD4CAR" cells) according to CTCAE grading. The feasibility of treating those adverse events and their duration till resolution will also be described.