Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT06197672 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusSuspended
PhasePhase 1
Started2024-03-19
View on ClinicalTrials.gov ↗

Amendment history

2026-09-25
Recruitment suspended: Trial being transferred to new lead site
2026-06-22
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v10
Primary completion moved earlier: 2027-12-31 → 2027-12
Completion moved earlier: 2042-12-31 → 2042-12
Eligibility criteria+1,233 characters
[...] e progression by increasing number of blasts is documented, patientsubject will be eligible. If no morphologic remission (persistent B [...] ractory and will qualify for this trial. This is unless the patientsubject now qualifies for a more intensive induction therapy that t [...] ation would not be a prerequisite to qualify for the study. Note: If these patientssubjects who fail first line treatment have an FDA approved treatmen [...] sive to those. If an approved second line is not available, patientssubjects will be eligible after first line failure. Creatinine clear [...] T/AST < 3 x ULN Bilirubin < 2 x ULN (UPPER LI [...]
Secondary endpointsdetails revised at 1 of 3 entries
Study description+109 characters
[...] ing this into account, the investigators expect to treat 15 patientssubjects. The study will utilize autologous CD4CAR T-cells that are [...] press CD4 on their blasts. At entry, disease status will be stagedassessed. Qualifying subjects will be leukapheresed to obtain large [...] heral blood mononuclear cells (PBMC) for the manufacturing. NextThen, participants will receive conditioning chemotherapy. If tumor burden is sufficiently reduced (screening step)Next, participants will receive CD4CAR cells by infusion on Day 0 of treatment. (The initial dose for this trial will be the highest dose level that wa [...] [...]
2026-01-20
Study Status, Contacts/Locations v9
Study sitescontacts updated at 1 of 4 sites
2025-10-29
Study Status, Oversight, Contacts/Locations v8
Study sites3→4
2025-10-08
Study Status, Sponsor/Collaborators, Contacts/Locations v7
Study sites2→3
Collaborators+23 characters
iCell Gene Therapeutics
Show 6 earlier versions
2025-08-15
Study Status, Outcome Measures, Eligibility v6
Eligibility criteria+297 characters
[...] e discussed with and permitted by the Principal Investigator. Participation in another clinical study with an investigational product within the past 6 months provided patient was in fact given that experimental treatment, just being enrolled and treated is not a disqualifier. Eligibility for Conditioning Chemotherapy: Specific organ fu [...] changes include heart attack, stroke, and any major trauma). Planned infusion does was successfully manufactured and met release criteria. Negative pregnancy testing (if applicable). Eligibility for CD4CAR infusion: Afebrile and not receiving [...] sment, and the PFT [...]
Primary endpoints4 entries, revised
[...] b. Serial testing for CD4CAR proliferation, differentiation, and polarization if feasible overtime after infusion.
2025-06-24
Study Identification, Study Status, Contacts/Locations v5
Study sites1→2
Study titlerevised
Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) Asas a Bridge to Allogeneic Stem Cell Transplant
2024-11-25
Study Status, Study Description, Outcome Measures v4
Secondary endpoints3 entries, revised
Describe disease response. using European LeukemiaNet (ELN) 2022 recommendation
2024-10-30
Study Identification, Study Status, Oversight, Outcome Measures, Eligibility v3
Eligibility criteria+1,375 characters
Inclusion Criteria: ≥ 1812 years old at the time of informed consent Ability to provid [...] and HIPAA authorization. Diagnosis of AML that is CD4+ and ismust recurrenthave orfailed refractorystandard toinduction/ first line standardtreatment such as intensive induction or less intensive hypomethylation and venetoclax first line. In the specific case of careazacitidine and venetoclax (aza/ven), BM biopsy for response assessment on days 21-28 of first cycle. If disease progression by increasing number of blasts is documented, patient will be eligible. If no morphologic remission (persistent BM blasts [...] [...]
Secondary endpointsdetails revised at 1 of 3 entries
Primary endpoints4 entries, revised
[...] than the Dose Limiting Toxicity (DLT) of the CD4CAR in AML. Optimal dose is highest safe dose that produces the most response.
Study titlerevised
Chimeric Antigen Receptor T Cell Redirected to Target CD4 Positive Relapsed Refractory Acute Myeloid Leukemia (AML ) asAs a Bridge to Allogeneic Stem Cell Transplant
2024-04-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-03→confirmed 2024-03-19
Study sitesdetails revised at 1 of 1 site
2024-03-04
Study Status v1
Start date2024-01→2024-03
2023-12-27
Original filing
This study is designed as a single arm open label traditional Phase I, 3+3, study of CD4-redirected chimeric antigen receptor engineered T-cells (CD4CAR) in subjects with relapsed or refractory AML. The study will evaluate safety in this subject population and also the presence of efficacy signal described by elimination of residual disease to qualify subjects for stem cell transplant.
Trial Details
NCT Number NCT06197672
Lead Sponsor Huda Salman
Collaborators: iCell Gene Therapeutics
Conditions Acute Myeloid Leukemia
Enrollment 30 participants
Start Date 2024-03-19
Primary Completion 2027-12 (estimated)
Study Completion 2042-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-30