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CD4CAR for Relapsed/Refractory Acute Myeloid Leukemia (AML)

This study is testing a new cell therapy called CD4CAR for people aged 12 and older with acute myeloid leukemia (AML) that has come back or hasn't responded to standard treatments. CD4CAR cells are your own immune cells (T-cells) that are specially modified in a lab to find and attack AML cells that have a marker called CD4. The main goals are to find the safest and most effective dose of CD4CAR and to see if it can reduce the amount of AML in your body enough to allow for a stem cell transplant. This study is currently recruiting about 30 participants.

Study design
This is a single-arm, open-label Phase 1 study, meaning all participants receive the CD4CAR treatment, and both you and the study team will know what treatment you are getting. It plans to enroll about 30 participants.
What's involved
You would undergo a procedure called leukapheresis to collect your blood cells, receive chemotherapy, and then get the CD4CAR cells through an infusion. Your blood and bone marrow will be tested regularly for at least 28 days after the infusion.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor the CD4CAR cells and their effects on your body for at least 28 days after the infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06197672

Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) as a Bridge to Allogeneic Stem Cell Transplant

Recruiting
PHASE1Ages 12+InterventionalTreatment
Huda Salman
~30 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:CD4CAR

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
1. Dose finding: Maximum tolerated dose (MTD) is defined as one dose level lower than the Dose Limiting Toxicity (DLT) of the CD4CAR in AML. Optimal dose is highest safe dose that produces the most response.
Measured over Day 0 through Day 28 post-infusion
+3 more outcomes measured

Conditions

Acute Myeloid Leukemia

Explore related trials

Acute Myeloid LeukemiaCD4 Gene

Where it's being run

4 sites across 3 states
Indiana2
Florida1
Texas1

Study leadership

  • Huda Salman, MD, PhD · PRINCIPAL_INVESTIGATOR · Indiana University

Who to contact

Tara Haney, RN
[email protected]
(317) 278-4184
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Subject develops a respiratory infection that results in significant changes in lung imaging from baseline
Subject's oxygenation from daily activities is compromised at baseline; or there is a significant change in oxygenation or lung imaging from baseline 3. If previous history of corticosteroid chemotherapy, subject must be off all but adrenal replacement doses 3 days before the CD4CAR infusion.

Exclusion

Subjects with a history of hepatitis B but have received antiviral therapy and have non-detectable 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 subjects 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. 5. Concurrent use of systemic glucocorticoids in greater than replacement doses 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 (e.g., lethargy, headache, weakness, pseudo rheumatism, emotional disturbances, etc) precipitated by the temporary stoppage unless tapering can occur safely without compromising the underlying disease, the withdrawal tolerance and can happen in a timeframe appropriate to enroll in this trial without safety concerns

What this trial measures

  • 1. Dose finding: Maximum tolerated dose (MTD) is defined as one dose level lower than the Dose Limiting Toxicity (DLT) of the CD4CAR in AML. Optimal dose is highest safe dose that produces the most response.Day 0 through Day 28 post-infusion

    In this traditional phase 1 dose escalation, cohorts of three subjects will be treated on a dose level that will be incremented to next dose level if no dose limiting toxicities (DLT) were reported or expanded if a DLT is documented.

  • Persistence and biologic behavior of CD4CAR as measured by a. Serial blood and marrow sampling to detect CD4CAR over time post infusion. b. Serial testing for CD4CAR proliferation, differentiation and polarization if feasible overtime after infusion.Day 0 Through Day28 post infusion

    The persistence of the CAR through day 28 and possibly longer if detected by D28. This will be performed by flow to assess for the CD3+/Fab2+ cell population The phenotype of the CAR will be determined by flow as well, to look for Tcm phenotype

  • 3. Determine the influence of CD4CAR on T regsDay 0 through Day 28

    1. Examine the efficacy of CD4CAR on changing the frequency of T regs subpopulation after CD4CAR infusion as compared to their frequency prior to treatment. 2. Determine the impact of the change in T regs and MDSCs abundance on objective response to CD4CAR.

  • Determine the influence of CD4CAR on myeloiod derived suppressor cells, MDSCsDay 0 through Day 28

    Examine the efficacy of CD4CAR on changing the frequency of MDSCs subpopulation