CD4CAR for CD4+ Leukemia and Lymphoma
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age12+
SponsorHuda Salman
About this trial
This study is designed as a single arm open label Phase I, 3x3, multicenter study of CD4-directed chimeric antigen receptor engineered T-cells (CD4CAR) in patients with relapsed or refractory T-cell leukemia and lymphoma. Specifically, the study will evaluate the safety and feasibility of CD4CAR T-cells. Funding Source - FDA OOPD
Eligibility criteria
Qualifiers
Patients must voluntarily sign and date informed consent forms that state his or her willingness to comply with all study procedures and availability for the duration 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 (including 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) are eligible. Response criteria for each disease subset will be evaluated based on Standard of Care Guidelines.
Creatinine clearance of > 60 ml/min (or otherwise non clinically-significant, per study investigator)
Disqualifiers
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.
Subjects with a history of hepatitis B but have received antiviral therapy and have nondetectable viral DNA for 6 months prior to enrollment are eligible
Trial design
Treatments tested in this trial
- CD4CAR
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Huda Salman
Lead sponsor
Indiana University
Sponsor institution
iCell Gene Therapeutics
Collaborator
National Institutes of Health (NIH)
Collaborator
Source ClinicalTrials.gov