# CD4 Redirected Chimeric Antigen Receptor T Cell Therapy for CD4 Positive T Cell Neoplasms

> **NIH FDA R01** · INDIANA UNIVERSITY INDIANAPOLIS · 2020 · $526,876

## Abstract

Project summary/abstract
This is a phase I, 3+3 dose escalation, first in man, clinical trial to study CD4 Redirected Chimeric Antigen
Receptor T Cell Therapy (CD4CAR) for CD4 Positive T cell heavily pretreated or refractory patients with
CD4+ T cell malignancies. The investigational agent to be studied are autologous CD4CAR T-cells
engineered to express an anti-CD4scFV domain derived from the monoclonal antibody (mAb) Ibalizumab
(Hu5A8 or TNX-355) paired with an intracellular tyrosine-based activation motif from the T-cell receptor
(TCR) and two costimulatory domains, CD28 and 4BB via lentiviral transduction in a good manufacturing
practice (GMP) clean facility. We plan to enroll up to 30 patients in order to treat ̴15 subjects (accounting
for screen and manufacturing failures) with CD4CAR. Eligible subjects are patients with relapsed or
refractory CD4 positive T cell lymphoma and leukemia to second line standard therapy. The primary
objective of the clinical trial is to test the feasibility to manufacture and the safety of CD4CAR cells in this
patient population. Subjects will be screened and entered into the study if eligible. Subjects will then be
conditioned with cytoreductive chemotherapy using cyclophosphamide and fludarbine for
lymphodepletion. After meeting release criteria CD4CAR autologous cells will be administered over a short
infusion time. Patients will be hospitalized for the period of infusion and till expected serious side effects
are resolved. Major side effects include cytokine release syndrome and neurotoxicity, accelerated CAR
proliferation, and generation of replication capable lentivirus. As well as infections related to CD4-deplete
host. Strict prophylaxis and monitoring for early treatment for all of those will be implemented. Study
subjects will be monitored closely during and after discharge from hospital with physical exams, lab work,
CAR T persistence testing and end organ toxicity. Description of objective responses will be recorded. This
is a high risk study with long follow up (up to 15 years).

## Key facts

- **NIH application ID:** 10616971
- **Project number:** 7R01FD006820-02
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Huda Salman
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2020
- **Award amount:** $526,876
- **Award type:** 7
- **Project period:** 2020-09-20 → 2026-07-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10616971

## Citation

> US National Institutes of Health, RePORTER application 10616971, CD4 Redirected Chimeric Antigen Receptor T Cell Therapy for CD4 Positive T Cell Neoplasms (7R01FD006820-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10616971. Licensed CC0.

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