A Phase I, Multicenter Study of CD4- Directed Chimeric Antigen Receptor Engineered T-cells (CD4CAR) in Patients With Relapsed or Refractory CD4+ Hematological Malignancies

Who is this study for? Patients with relapsed or refractory CD4+ hematological malignancies
What treatments are being studied? CD4CAR
Status: Recruiting
Location: See all (4) locations...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

⁃ In order to be eligible to participate in this study, an individual will be enrolled if they meet the following criteria:

• 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)

• ALT/AST \< 3 x ULN

• Bilirubin \< 2 x ULN

• Pulmonary Function Test (PFT) with a DLCO of ≥ 60%.

• Adequate echocardiogram with EF of ≥50%

• Adequate venous access for apheresis and no other contraindications for leukapheresis

Locations
United States
Florida
University of Miami Sylvester Comprehensive Cancer Center
RECRUITING
Miami
Indiana
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
RECRUITING
Indianapolis
New York
Albert Einstein Health Network
RECRUITING
New York
Stony Brook Cancer Center
ACTIVE_NOT_RECRUITING
Stony Brook
Contact Information
Primary
Tara Haney, RN
tnhaney@iu.edu
317-278-4184
Backup
Huda Salman, MD
hsalman@iu.edu
(317) 278-9504
Time Frame
Start Date: 2020-07-09
Estimated Completion Date: 2040-12
Participants
Target number of participants: 20
Treatments
Experimental: Treatment
Redirected autologous T cells transduced with the anti-CD4 lentiviral vector (referred to as CD4CAR cells)
Authors
William Tse
Sponsors
Collaborators: iCell Gene Therapeutics
Leads: Huda Salman

This content was sourced from clinicaltrials.gov

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