NCT04214886

CD19 Chimeric Antigen Receptor (CAR) T Cells for Adults With Recurrent or Refractory B Cell Malignancies

Dose Escalation Study of CD19 Chimeric Antigen Receptor (CAR) T Cells With a CD34 Selection Marker in Adults With Recurrent or Refractory B Cell Malignancies

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Loyola University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

In this protocol, the investigators hypothesize that modifying the process of producing CAR+ T-cells can help to improve responses and reduce toxicities. Building on previous in vitro studies that have shown successful production of CAR+ T-cells using a new production approach, the investigators are now studying the ability to produce these CAR+ T-cells and determine how well they work in the clinical setting.

Detailed description

Autologous peripheral blood mononuclear cell (PBMC) will be obtained by leukapheresis over one day and the cells will be transduced with an in house designed CAR retroviral vector. Participants will receive daily intravenous (IV) infusion of lymphodepleting regimen of fludarabine and cyclophosphamide for total of 3 days (Days -5, -4, -3). The dose of cyclophosphamide will be given at 500mg/m2. The dose of fludarabine will be given at 30mg/m2. Participants will receive the CAR transduced T cells IV infusion in the BMT Inpatient Unit and remain admitted for close monitoring for at least the first 7 days following the cell infusion (D0 to Day +7), possibly longer if any side effects are encountered. The CAR transduced T cells will be escalated from 1 x 106 transduced T cells/kg (± 20%) to 2 x 106 transduced T cells/kg (± 20%) in a Phase I design, based on toxicity. Once discharged from the inpatient unit, for the next 7 days (Day +8 to Day +14) the patients will be evaluated in the High Dose Unit (labs and physical exam) to screen for toxicities.

Conditions

• B-Cell Acute Lymphoblastic Leukemia, Adult
• B-cell Lymphoma Refractory
• B-cell Lymphoma Recurrent

Interventions

Type	Name	Description
DRUG	Fludarabine	Fludarabine is an anti-cancer drug acting as an antimetabolite that is used to treat leukemia and lymphoma cancers.
DRUG	Cyclophosphamide	Cyclophosphamide is is an anti-cancer drug acting as an alkylating agent that is used to treat leukemia and lymphoma cancers.
BIOLOGICAL	CD19-CD34 CAR transduced T cells	CD19-CD34 CAR transduced T cells are the subject's own immune cells that target B cell markers on cancer cells.

Timeline

• Start date: 2019-12-31
• Primary completion: 2022-08-11
• Completion: 2034-12-31
• First posted: 2020-01-02
• Last updated: 2022-08-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study