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

StatusSuspended
PhasePhase 1
Started2024-02-21
View on ClinicalTrials.gov ↗

Amendment history

2026-09-25
critical
Recruitment suspended: Trial being transferred to new lead site
2026-06-22
minor
Study Status, Contacts/Locations v10
Re-verified, no change to tracked fields
2026-03-16
minor
Study Status, Study Description, Outcome Measures, Eligibility v9
Eligibility criteria+1,021 characters
[...] r 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 a DLCOEF of ≥50%. This will not have to be repeated if within 45 days of initial assessment. Adequate echocardiogram 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 contraindi [...] this route pertains extremely minimal systemic penetration Any previous treatment with any gene therapy products Any uncontr [...] [...]
Secondary endpoints2 entries, revised
in vivo persistence of a single dose of the CD4CAR in patientssubjects with CMML
Study descriptionrevised
[...] ing this into account, the investigators expect to treat 15 patientssubjects. The study will utilize autologous CD4CAR T-cells that are [...] utilizing standard prophylaxis recommended for HIV-positive patientssubjects with T-cell aplasia and those undergoing allogeneic stem ce [...] ort- and intermediate-term evaluations are performed, these patientssubjects will enter a rollover study to assess for disease-free surv [...] e escalation in phase I is to avoid unnecessary exposure of patientssubjects to sub-therapeutic doses (i.e., to treat as many patientssubjects as possible within the therapeutic dose range) wh [...] [...]
2026-01-20
minor
Study Status, Contacts/Locations v8
Study sitescontacts updated at 1 of 4 sites
2025-10-31
minor
Study Status, Oversight, Eligibility, Contacts/Locations, IPDSharing v7
Study sites2→4
Eligibility criteria+202 characters
[...] in < 2 x ULN Pulmonary Function Test (PFT) with a DLCO of ≥ 6050%. This will not have to be repeated if within 45 days of in [...] nd permitted by the Principal Investigator Participation in anothera cell/gene therapy clinical study with an investigational product within the past 6 months; and/or no other clinical trial with an investigational product within the last 4 weeks, provided subject was in fact given that experimental treatment, just being enrolled and treated is not a disqualifier. Eligibility for cd4CAR Infusion Afebrile and not receiving [...] eed not be repeated if within 45 days of initial a [...]
Show 6 earlier versions
2025-08-15
minor
Study Status, Contacts/Locations v6
Study sites1→2
2025-05-16
minor
Study Status, Eligibility v5
Eligibility criteria+1,933 characters
[...] dose was successfully manufactured and met release criteria 5.5 Contraception and Reproductive Potential Guidelines Female subjects of reproductive potential (women who have reached menarche or women who have not been post-menopausal for at least 24 consecutive months, i.e., who have had menses within the preceding 24 months, or have not undergone a sterili [...]
2025-04-02
minor
Study Status, Eligibility v4
Eligibility criteria+72 characters
[...] discussed with and permitted by the Principal Investigator Participation in another clinical study with an investigational product Eligibility for cd4CAR Infusion Afebrile and not receiving a [...]
2025-02-05
minor
Study Status, Oversight, IPDSharing v3
Re-verified, no change to tracked fields
2024-02-26
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-01→confirmed 2024-02-21
Study sitesdetails revised at 1 of 1 site
2023-12-14
minor
Study Identification, Study Status v1
Start date2023-10→2024-01
Study title+45 characters
CD4CARChimeric Antigen Receptor T Cell Therapy Redirected to CD4 (CD4CAR)as a Second Line Treatment for Chronic Myelomonocytic Leukemia, CMML.
2023-10-02
minor
Original filing
2,553 trials monitored
See 134 trials at risk
180 trials monitored
See 13 trials at risk
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.
Trial Details
NCT Number NCT06071624
Lead Sponsor Huda Salman
Collaborators: iCell Gene Therapeutics, The Leukemia and Lymphoma Society
Conditions Chronic Myelomonocytic Leukemia
Enrollment 30 participants
Start Date 2024-02-21
Primary Completion 2028-12 (estimated)
Study Completion 2043-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-24