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CD4CAR T-Cell Therapy for Chronic Myelomonocytic Leukemia (CMML)

This study is testing a new treatment called CD4CAR for people with Chronic Myelomonocytic Leukemia (CMML) that has come back or hasn't responded to standard treatments. CD4CAR uses your own immune cells, called T-cells, which are specially modified in a lab to find and fight CMML cells that have a specific marker called CD4. The main goals are to find the safest dose of CD4CAR and to see how well it works to treat CMML. You may be able to join if you are 18 or older, have CD4+ CMML that is recurrent or refractory, and meet certain health requirements. This study is currently recruiting participants.

Study design
This is a single-arm, open-label study, meaning all participants will 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
If you qualify, you will have blood drawn to collect your T-cells, receive chemotherapy, and then get the CD4CAR cells through an infusion. The study will monitor you for at least 6 months after the infusion.
Compensation
Not stated in the trial record.
Follow-up
Your response to the treatment will be measured from Day 28 through 6 months 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.

NCT06071624

Chimeric Antigen Receptor T Cell Therapy Redirected to CD4 (CD4CAR)as a Second Line Treatment for Chronic Myelomonocytic Leukemia, CMML.

Recruiting
PHASE1Ages 18+InterventionalTreatment
Huda Salman
~30 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:CD4CAR

At a glance

Recruiting sites
3 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Dose finding: Maximum tolerated dose (MTD) is defined as one dose level lower than the dose limiting toxicity (DLT) of the CD4CAR in CMML
Measured over Day 0 through Day 28 post-infusion
+1 more outcome measured

Conditions

Chronic Myelomonocytic Leukemia

Explore related trials

Chronic Myelomonocytic LeukemiaCD4 Gene

Where it's being run

4 sites across 4 states
Florida1
Indiana1
New York1
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

Condoms (male or female) with or without a spermicidal agent.
Diaphragm or cervical cap with spermicide
Intrauterine device (IUD)
Hormonal-based contraception
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 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 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 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 (eg, 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

  • Dose finding: Maximum tolerated dose (MTD) is defined as one dose level lower than the dose limiting toxicity (DLT) of the CD4CAR in CMMLDay 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

  • The efficacy of treatment with CD4CAR and description of CMML response to CD4CARDay 28 through 6 months post-infusion

    serial marrow sampling will be analysed for response as measured by reduction on the CMML clonal cells at different time points. Other measures include reduction on transfusion dependency and molecular remissions if at diagnoosis molecular markers were identified.