Autologous ROR1R-CAR-T Cells for Chronic Lymphocytic Leukemia (CLL)

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT02194374
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • ROR1R-CAR-T Cell Infusion — PROCEDURE
    Dose Escalation Cohort starting dose level of ROR1R-CAR-T cells/kg: 105 cell/kg infused via central venous catheter or by vein on Day 1. Dose Expansion Cohort starting dose level of ROR1R-CAR-T cells/kg: MTD from Dose Escalation Cohort.
  • Fludarabine — DRUG
    FCR Regimen: 25 mg/m2 by vein on Days -5, -4, and -3. FBR Regimen: 20 mg/m2 by vein Days -5, -4, and -3.
  • Cyclophosphamide — DRUG
    FCR Regimen : 250 mg/m2 by vein on Days -5, -4, and -3.
  • Rituximab — DRUG
    FCR and FBR Regimen: 375-500 mg/m2 by vein on Day -5. BR Regimen: 375-500 mg/m2 by vein on Day -4.
  • Bendamustine — DRUG
    BR Regimen: 70-90 mg/m2 by vein on Days -4 and -3. FBR Regimen: 30-50 mg/m2 by vein on Days -5 to -3.

Study Details

Gene transfer is a process in which the DNA (genetic material) of certain cells is changed. In this study, gene transfer will be performed on a type of white blood cell (called T cells) to recognize leukemia cells in the same person the T cells were collected from. The goal of this clinical research study is to learn if it is safe to give these genetically-changed T cells back to patients with CLL/SLL. Researchers also want to learn if these cells can help to attack CLL/SLL cells.

Key Dates

Start date
Jan 31, 2015
Status verified
Jun 2017
Primary completion
Jun 30, 2017
Completion
Jun 30, 2017

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: ROR1R-CAR-T Cells
    Peripheral blood mononuclear cells (PBMC) collected via venipuncture and/or steady state leukapheresis at discretion of PI. Participants receive a cycle of lympho-depleting chemotherapy as chosen by treating physician 4 to 5 days before ROR1R-CAR-T cell infusion : Fludarabine, Cyclophosphamide, and Rituximab (FCR), Bendamustine and Rituximab (BR), or Fludarabine, Bendamustine, and Rituximab (FBR). Dose Escalation Cohort starting dose level of ROR1R-CAR-T cells/kg: 105 cell/kg infused via central venous catheter or by vein on Day 1. Dose Expansion Cohort starting dose level of ROR1R-CAR-T cells/kg: MTD from Dose Escalation Cohort.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) of ROR1R-CAR-T Cells for Chronic Lymphocytic Leukemia (CLL) / Small Lymphocytic Lymphoma (SLL) [ Time Frame: 4 weeks ]

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