2026-06-22
critical
Study Status, Contacts/Locations v20
Primary completion pushed: 2026-12 → 2027-12
Completion pushed: 2041-12 → 2042-12
2026-01-20
minor
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v18
Primary completion date2025-12→2026-12
Completion date2040-12→2041-12
Eligibility criteria-2,320 characters
[...] r study investigator)
ALT/AST < 3 x ULN
Bilirubin < 2 x ULN
No supplemental oxygen at rest Note: Pulmonary Function Test (PFT) withonly arequired DLCOper oftreating ≥physician 60%.discretion
Adequate echocardiogramcardiac function with EF of ≥50%
Adequate venous access for apheresis and no [...] of hepatitis B but have received antiviral therapy and have non-detectablenondetectable viral DNA for 6 months prior to enrollment are eligible
Sub [...] this route pertains extremely minimal systemic penetration.
Any previous treatment with any gene therapy products.
Any uncontrolled active medical disorder that wo [...] [...]
Secondary endpointsdetails revised at 3 of 9 entries
Study description-84 characters
[...] containing the following infusible grade reagents (% v/v): 624.5cc Plasmalyte-A 5% dextrose;human 7.5ccserum Purealbumin dimethylsulfoxidewith (DMSO), 20cc of 2510% Human Serum Albumin, and 10cc Dextran 40DMSO.
The cell product is expected to be ready for release appro [...]
Study sitescontacts updated at 1 of 6 sites
Show 15 earlier versions
2025-06-03
minor
Study Identification, Study Status, Eligibility, Contacts/Locations v15
Eligibility criteria+2,028 characters
[...] discussed with and permitted by the Principal Investigator.
Participation in another clinical study with an investigational product within the past 18 months.
Eligibility for Conditioning Chemotherapy
Specific organ fun [...] adrenal replacement doses 3 days before the CD4CAR infusion.
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 sterilizati [...]
2024-10-22
minor
Study Identification, Study Status, Oversight, Eligibility, Contacts/Locations v14
Eligibility criteria-388 characters
[...] ration of the study.
Age 12 years old or older
Subjects with any documented CD4+ T cell hematologic malignancies.
Male and female subjects with CD4+ T-cell hematologic malignancies with either relapsed or refractory disease (in [...] luding those patients who have undergone a prior transplant (if allogeneic, subjects are eligible if there are no remaining donor cells) and patients with an inadequate response after 4-6 cycles of standard chemotherapy)
For patients who present with CD4+ Leukemia, either relapsed disease or minimal residual disease (MRD); any of the following are eligible:.
PeripheralRe [...] [...]
Study sitescontacts updated at 2 of 3 sites
2024-08-28
minor
Study Status, Outcome Measures v13
Completion date2037-12→2040-12
Secondary endpoints7 to 9 entries
Overall survival and causes of death
New onset malignancies post CD4CAR treatment
2024-05-20
minor
Study Status, Sponsor/Collaborators, Eligibility, Contacts/Locations v12
Eligibility criteria+362 characters
[...] cedures and availability for the duration of the study.
Age 1812 years old or older
Subjects with documented CD4+ hematologi [...] discussed with and permitted by the Principal Investigator.
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 [...] Screen Failure
Subjects who fail to cytoreduce with conditio [...] liver function must be similar to initial inclusion valu [...]
2024-03-04
minor
Study Status v11
Start date2019-06-18→2020-07-09
2024-02-26
minor
Study Status, Contacts/Locations v10
Re-verified, no change to tracked fields
2023-09-15
minor
Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v9
Eligibility criteria-469 characters
[...] ty for the duration of the study.
Age 18 years old or older
Absolute lymphocyte count ≥500/mm3
Subjects with documented CD4+ hematologic malignancies.
Male [...]
HIV infection.
Patients declining to consent for treatment
Absolute lymphocyte count <500/mm3 (<0.5 x 109 /L) (can be repeated, if indicated and possible)
Subjects who have received or will receive live vaccines wit [...] ed with and permitted by the Principal Investigator.
Screen FailuresFailure
First point screen failure: Apheresis Subject with an absolute lymphocyte count < 500/mm3 at the time of apheresis will be considered a screenfailure.
No [...] [...]
Study description+16 characters
[...] e investigators expect to recruit 20 subjects at Stony Brook, Indiana University, and other identified sites with an expected dropout rate of 25% primarily due to rapid [...] staged and investigators will determine if the subject has the minimaladequate T cell number adequate for apheresis (screening step) and for manufacturing CD4CAR cells.
qualifyingQualifying subjects will be leukapheresed to obtain large numbers of p [...] l tumor burden starting on day 6 and weekly afterward until remissionday 42 and then monthly for 6 months.
This will be followed by qua [...] ll be initiated on lymphodepleting chemotherapy [...]
2023-08-28
minor
Study Status, Study Description, Outcome Measures, Eligibility, Contacts/Locations v8
Eligibility criteria+2,903 characters
[...] ty for the duration of the study.
Age 18 years old or older
T-cellAbsolute lymphocyte count ≥500/mm3
Subjects with documented CD4+ hematologic malignancies.
Mal [...] search 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 [...] Co [...] [...]
Secondary endpoints7 entries, revised
traffickingTrafficking of CD4CAR at tumor sites and at sites with significant toxicity
determineDetermine CD4CAR cell subsets during proliferation
Study description+152 characters
[...] r for the dose level to be infused.
Post-infusion monitoring of CD4CAR T-cells: Subjects will have blood drawn for cytokine levels, CD4CAR Transgene Copy Number (PCR) and flow cytometry in order to evaluate the presence of CD4CAR cells on days 0, 1, 3, 5, 7, 14, 28, and 2842 following infusion of(or CD4CARas T-cells,clinically evaluation of leukemic cell killing and CD4CAR Trafficking will be doneneeded).
Cytokines levels will be evaluated onper Dayschedule 2,above 4,in 7,addition 11, 14, 21, 28to and as needed every 8 +/- 2 hours duringas activefeasible cytokineif/when releaseCRS syndromeoccu [...] [...]
2022-12-16
notable
Active, Not Recruiting→Recruiting Study Status, Eligibility, Contacts/Locations v7
Trial statusActive, Not Recruiting→Recruiting
Eligibility criteria+2,522 characters
[...] procedures and availability for the duration of the study.
Age 18 years old or older
T-cell ≥ 500
Subjects with documented CD4+ hematologic malignancies.
Male [...] dequate response after 4-6 cycles of standard chemotherapy)
PatientsFor patients who present with CD4+ Leukemia.
Either, either relapsed disease or minimal residual disease (MRD); any of the following are eligible:
3.1 Peripheral T-cell leukemia, NOS 3.2
T-cell prolymphocytic leukemia 3.3
Adult T-cell leukemia 3.4
T-cell large granular lymphocytic leukemia 3.5
T cell acute lymphoblastic leukemia (T-ALL)
For patients with CD4+ Lymphom [...] [...]
Study sitesdetails revised at 1 of 1 site
2022-09-16
minor
Study Status v6
Primary completion date2022-12→2025-12
2021-12-02
notable
Recruiting→Active, Not Recruiting Study Identification, Study Status, Sponsor/Collaborators, Contacts/Locations v5
Trial statusRecruiting→Active, Not Recruiting
Lead sponsorHuda Salman, MD→Huda Salman
Study sites1 entry, revised
Stony BrookIndiana University Melvin and Bren Simon Comprehensive Cancer Center
2021-06-22
minor
Study Identification, Study Status, Sponsor/Collaborators, Study Description, Outcome Measures, Eligibility v4
Lead sponsorStony Brook University→Huda Salman, MD
Eligibility criteria+26 characters
[...] ymphocytic leukemia 3.5 T cell acute lymphoblastic leukemia (T-ALL)
For patients with CD4+ Lymphoma.
Either relapsed or refract [...] e 18 years old or older
Creatinine clearance of > 60 ml/min
ALT/ASTLiver enzymes < 3 x ULNupper limit of normal
Bilirubin < 2.0 mg/dL
Serum albumin of ≥ 3gms/dl
Pulmonary [...]
Secondary endpointsdetails revised at 1 of 7 entries
2019-09-17
minor
Study Status v3
Start dateestimated 2019-06-15→confirmed 2019-06-18
2019-06-14
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2019-07→2019-06-15
Study sitesdetails revised at 1 of 1 site
2019-05-29
notable
Recruiting→Not Yet Recruiting Study Status, Sponsor/Collaborators, Contacts/Locations, IPDSharing v1
Trial statusRecruiting→Not Yet Recruiting
Primary completion date2020-08→2022-12
Completion date2021-06→2037-12
Start date2019-03→2019-07
Study sites2→1
Collaborators+23 characters
iCell Gene Therapeutics