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
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
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