search
Back to results

Allo CART-19 Protocol

Primary Purpose

Acute Lymphocytic Leukemia

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
CART-19
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Lymphocytic Leukemia focused on measuring adult patients, aged 18, CD19+ ALL relapsed, after allogeneic SCT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • CD19+ ALL relapsed after allogeneic SCT.
  • No active GVHD and off immunosuppression for greater than or equal to 4 weeks.
  • Age greater than or equal to 18 years.
  • Creatinine less than or equal to2.5 mg/dl.
  • ALT/AST less than or equal to3x normal
  • Bilirubin less than or equal to2.0 mg/dl
  • Donor is available and is able to undergo apheresis. A separate donor consent process and form is described below.
  • Voluntary informed consent is given.

Exclusion Criteria:

  • Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion.
  • Uncontrolled active infection.
  • Active hepatitis B or hepatitis C infection.
  • Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary.
  • Previously treatment with any gene therapy products.
  • Feasibility assessment during screening demonstrates less than 30% transduction of target lymphocytes, or insufficient expansion ( less than 5-fold) in response to CD3/CD28 costimulation..
  • Any uncontrolled active medical disorder that would preclude participation as outlined.
  • HIV infection.
  • Patients with active CNS involvement with leukemia. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was greater than or equal to 4 weeks before enrollment
  • Patients with active GVHD or requiring immune suppression.

Sites / Locations

  • Abramson Cancer Center of the University of Pennsylvania

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Number of Adverse Events

Secondary Outcome Measures

Full Information

First Posted
March 8, 2012
Last Updated
July 7, 2020
Sponsor
University of Pennsylvania
search

1. Study Identification

Unique Protocol Identification Number
NCT01551043
Brief Title
Allo CART-19 Protocol
Official Title
Pilot Study of Donor Lymphocyte Infusions Using Donor T Cells Engineered to Contain Anti-CD19 Attached To TCR And 4-1BB Signaling Domains in Patients With Relapsed CD19+ All After Allogeneic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Administrative Reasons
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective is to determine the safety and survival of the redirected allogeneic T cells transduced with the anti-CD19 lentiviral vector (referred to as CART-19 cells).
Detailed Description
The investigators propose an open label, single center, pilot study to evaluate the safety and tolerability, and persistence of donor lymphocytes engineered to express a chimeric antigen receptor targeting CD19 which is linked to the CD3:4-1BB signaling chains in patients with CD19+ acute lymphoblastic leukemia (ALL). Upon enrollment, donors will undergo leukapheresis and patients will undergo an optional bone marrow/lymph node biopsy approximately four weeks prior to dosing. Between dosing and treatment, patients may undergo an additional chemotherapy treatment depending upon their disease. At dosing, patients will receive redirected donor lymphocytes targeted against CD19 (allo-CART-19 cells). The cell dose will be given as a split infusion over three days to enhance the ability to manage any infusion related toxicity. Patients will be monitored weekly for four weeks. At the end of four weeks, patients will undergo a second leukapheresis and second optional bone marrow/lymph node biopsy. At this point the patient will also undergo restaging. Observation and monitoring of patients will continue on a monthly basis until week 24 post dosing. Annual follow-up for lentiviral vector safety will be carried out for 15 years in accordance with FDA guidelines for retroviral vectors. Ten subjects will be targeted for this study, with an expected rate of drop out of 30% due to disease progression between enrollment and week four post dosing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Lymphocytic Leukemia
Keywords
adult patients, aged 18, CD19+ ALL relapsed, after allogeneic SCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
CART-19
Primary Outcome Measure Information:
Title
Number of Adverse Events
Time Frame
26 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CD19+ ALL relapsed after allogeneic SCT. No active GVHD and off immunosuppression for greater than or equal to 4 weeks. Age greater than or equal to 18 years. Creatinine less than or equal to2.5 mg/dl. ALT/AST less than or equal to3x normal Bilirubin less than or equal to2.0 mg/dl Donor is available and is able to undergo apheresis. A separate donor consent process and form is described below. Voluntary informed consent is given. Exclusion Criteria: Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion. Uncontrolled active infection. Active hepatitis B or hepatitis C infection. Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. Previously treatment with any gene therapy products. Feasibility assessment during screening demonstrates less than 30% transduction of target lymphocytes, or insufficient expansion ( less than 5-fold) in response to CD3/CD28 costimulation.. Any uncontrolled active medical disorder that would preclude participation as outlined. HIV infection. Patients with active CNS involvement with leukemia. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was greater than or equal to 4 weeks before enrollment Patients with active GVHD or requiring immune suppression.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Porter, MD
Organizational Affiliation
Abramson Cancer Center at Penn Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Allo CART-19 Protocol

We'll reach out to this number within 24 hrs