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

Recruiting now · Phase 1

Conditions studied: Chronic Myelomonocytic Leukemia

In brief

This study is designed as a single arm open label traditional Phase I, 3+3, study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in subjects with relapsed or refractory CMML. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells.

Key facts

Study ID

NCT06071624

Run by

Huda Salman

People needed

30

Starts

2024-02-21

Expected to finish

2043-12-01

Last updated by the study team

2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 18 years old at the time of informed consent
• Ability to provide written informed consent and HIPAA authorization
• Diagnosis of CMML that is CD4+ and is recurrent or refractory to first line standard of care treatment.
• Creatinine clearance of ≥ 60 ml/min (or otherwise non clinically significant, per study investigator)
• ALT/AST < 3 x ULN
• Bilirubin < 2 x ULN
• No supplemental oxygen at rest Note: Pulmonary Function Test (PFT) only required per treating physician discretion.
• Adequate cardiac function with EF of ≥50%. This will not have to be repeated if within 45 days of initial assessment
• Adequate venous access for apheresis and no other contraindications for leukapheresis

You may not qualify if…

• CD4 negative CMML
• Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential (see definition below) must have a negative serum or urine pregnancy test prior to initiation of conditioning chemotherapy, per research sites' clinical policy
• Uncontrolled active infection necessitating systemic therapy
• Active hepatitis B or hepatitis C infection. Active hepatitis C is defined as the hepatitis C antibody is positive while quantitative HCV RNA results exceed the lower detection limit
• Note the following subjects will be eligible:
• 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
• 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
• Subjects who receive daily corticosteroids in replacement doses can be included in the study. The replacement doses are defined as following:
• Hydrocortisone 25mg/day or less
• Prednisone 10mg/day or less
• Dexamethasone 4mg or less - Note: Recent or current use of inhaled glucocorticoids is not exclusionary, as this route pertains extremely minimal systemic penetration
• Any uncontrolled active medical disorder that would preclude participation as outlined in the opinion of the treating investigator and/or Principal Investigator
• HIV infection
• Subjects who have received or will receive live vaccines within 30 days before the first experimental cell treatment. Inactivated seasonal flu vaccination is allowed
• Subjects with active autoimmune diseases who need systematic treatments (such as disease modifying agents, corticosteroids and immunosuppressive drugs) during the last year Note: Replacement therapy (thyroxine, insulin or physiological corticosteroid replacement therapy (up to10 mg of oral daily prednisone or equivalent in hydrocortisone and dexamethasone) to treat adrenal dysfunction or pituitary dysfunction) is not considered as systematic therapy. Subjects who need inhalation corticosteroid therapy can be included in this trial. Subjects with vitiligo or in long-term remission of pediatric asthma or allergic diseases can be included in this trial
• Subjects with a history of mental disorders or drug abuse that may influence treatment compliance
• Active malignancy not related to CMML that has required therapy in the last 3 years or is not in complete remission. Exceptions to this criterion include successfully treated non-metastatic basal cell or squamous cell skin carcinoma, or prostate cancer that does not require therapy. Other similar malignant conditions may be discussed with and permitted by the Principal Investigator CMML patients who transformed into AML and who were treated back into CMML status are eligible. CMML patients who transformed into AML and appropriate AML treatment was unsuccessful in reverting their disease back to CMML status will be treated as AML patients and are not eligible for the CMML study.
• Treatment with any investigational cell/gene therapy within the past 6 months
• Treatment with any investigational anticancer agent within the last 14 days of study entry or 5 half-lives (whichever is shorter)
• Eligibility for Conditioning Chemotherapy:
• Specific organ function criteria for cardiac, renal, and liver function must be similar to initial inclusion values
• Review of co-morbidities to confirm no major changes in health status (examples of major changes include heart attack, stroke, and any major trauma)

Where it is running

• University of Miami Sylvester Comprehensive Cancer Center, Miami, Florida 33136 — Miami, Florida, United States (enrolling)
• Indiana University Melvin and Bren Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (enrolling)
• The University of Texas MD Anderson Cancer Center — Houston, Texas, United States (enrolling)
• Albert Einstein Health Network — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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