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A Phase 1 Study of CD22-CAR TCell Immunotherapy for CD22+ Leukemia and Lymphoma (PLAT-04)

Primary Purpose

Leukemia

Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Patient-derived CD22-specific CAR T-cells also expressing an EGFRt
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring leukemia, CD 22, CAR T cell, pediatric, young adult, chimeric antigen receptor

Eligibility Criteria

1 Year - 26 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • First 3 subjects: male and female subjects age ≥ 18 years and < 27 years
  • Subsequent subjects: 12 months of age and <27 years of age at the time of study enrollment

  • Disease status (one of the following):

    1. If post-allogeneic hematopoetic cell transplant (HCT): confirmed CD22+ leukemia recurrence, defined as ≥0.01% disease

    2. If Relapse/Refractory status with no prior history of allogeneic HCT, one of:

      • 2nd or grater marrow relapse, with or without extramedullary disease
      • 1st marrow relapse at end of 1st month of re-induction with marrow having ≥0.01% blasts by morphology and/or MPF
      • Primary Refractory, defined as >5% blasts by multi-parameter flow after ≥2 separate induction regimens
      • Subject has indication for HCT but is ineligible, inclusive of persistent minimal residual disease
    3. CD22+ Lymphoma refractory or relapsed with no known curative therapies available
  • Asymptomatic from CNS involvement, if present, and have a reasonable expectation that disease burden can be controlled in the interval between enrollment and T-cell infusion. Subjects with significant neurologic deterioration will not be eligible for T-cell infusion until stabilized.
  • Free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks.
  • Lansky or Karnofsky performance score of ≥50
  • Life expectancy of >8 weeks
  • Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy
  • ≥7 days post last chemotherapy administration (excluding intrathecal or maintenance chemotherapy)
  • ≥7 days post last systemic corticosteroid administration
  • No prior virotherapy
  • Adequate organ function
  • Adequate laboratory values
  • Patients of childbearing/fathering potential must agree to use highly effective contraception
  • Signed a written consent

Exclusion Criteria:

  • Presence of active clinically significant CNS dysfunction
  • Pregnant or breastfeeding
  • Unable to tolerate apheresis procedure, including placement of temporary apheresis line if required
  • Presence of active malignancy other than CD22+ leukemia or lymphoma
  • Presence of active severe infection
  • Presence of any concurrent medical condition that would prevent the patient from undergoing protocol-based therapy
  • Presence of primary immunodeficiency/bone marrow failure syndrome
  • Unwilling to participate in 15-year follow-up period that is required if CAR T cell therapy is administered

Sites / Locations

  • Seattle Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous CD22-specific CAR T-cells expressing EGFRt

Arm Description

Outcomes

Primary Outcome Measures

The adverse events associated with one or multiple CAR T-cell product infusions will be assessed
The type, frequency, severity, and duration of adverse events will be summarized
The number of successfully and unsuccessfully manufactured and infused CAR T-cell products will be assessed
Proportion of products successfully manufactured and infused

Secondary Outcome Measures

Full Information

First Posted
August 3, 2017
Last Updated
June 27, 2023
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03244306
Brief Title
A Phase 1 Study of CD22-CAR TCell Immunotherapy for CD22+ Leukemia and Lymphoma
Acronym
PLAT-04
Official Title
Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-04: A Phase 1 Feasibility and Safety Study of CD22-CAR T Cell Immunotherapy for CD22+ Leukemia and Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 27, 2017 (Actual)
Primary Completion Date
November 14, 2018 (Actual)
Study Completion Date
July 2035 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seattle Children's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and some patients who relapse following CD19 directed therapy relapse with CD19 negative leukemia. For this reason, the investigators are attempting to use T-cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR) to CD22, a different protein from CD19, expressed on the surface of the leukemic cell in patients with CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through the recognition of CD22, a protein expressed on the surface of the leukemic cell in patients with CD22+ leukemia. This is a Phase 1 study designed to determine the safety and feasibility of the CAR+ T - cells and the feasibility of making enough to treat patients with CD22+ leukemia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
leukemia, CD 22, CAR T cell, pediatric, young adult, chimeric antigen receptor

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Autologous CD22-specific CAR T-cells expressing EGFRt
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Patient-derived CD22-specific CAR T-cells also expressing an EGFRt
Intervention Description
Patient-derived CD22-specific chimeric antigen receptor T-cells expressing an EGFRt
Primary Outcome Measure Information:
Title
The adverse events associated with one or multiple CAR T-cell product infusions will be assessed
Description
The type, frequency, severity, and duration of adverse events will be summarized
Time Frame
30 days
Title
The number of successfully and unsuccessfully manufactured and infused CAR T-cell products will be assessed
Description
Proportion of products successfully manufactured and infused
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: First 3 subjects: male and female subjects age ≥ 18 years and < 27 years Subsequent subjects: 12 months of age and <27 years of age at the time of study enrollment Disease status (one of the following): If post-allogeneic hematopoetic cell transplant (HCT): confirmed CD22+ leukemia recurrence, defined as ≥0.01% disease If Relapse/Refractory status with no prior history of allogeneic HCT, one of: 2nd or grater marrow relapse, with or without extramedullary disease 1st marrow relapse at end of 1st month of re-induction with marrow having ≥0.01% blasts by morphology and/or MPF Primary Refractory, defined as >5% blasts by multi-parameter flow after ≥2 separate induction regimens Subject has indication for HCT but is ineligible, inclusive of persistent minimal residual disease CD22+ Lymphoma refractory or relapsed with no known curative therapies available Asymptomatic from CNS involvement, if present, and have a reasonable expectation that disease burden can be controlled in the interval between enrollment and T-cell infusion. Subjects with significant neurologic deterioration will not be eligible for T-cell infusion until stabilized. Free from active GVHD and off immunosuppressive GVHD therapy for 4 weeks. Lansky or Karnofsky performance score of ≥50 Life expectancy of >8 weeks Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy ≥7 days post last chemotherapy administration (excluding intrathecal or maintenance chemotherapy) ≥7 days post last systemic corticosteroid administration No prior virotherapy Adequate organ function Adequate laboratory values Patients of childbearing/fathering potential must agree to use highly effective contraception Signed a written consent Exclusion Criteria: Presence of active clinically significant CNS dysfunction Pregnant or breastfeeding Unable to tolerate apheresis procedure, including placement of temporary apheresis line if required Presence of active malignancy other than CD22+ leukemia or lymphoma Presence of active severe infection Presence of any concurrent medical condition that would prevent the patient from undergoing protocol-based therapy Presence of primary immunodeficiency/bone marrow failure syndrome Unwilling to participate in 15-year follow-up period that is required if CAR T cell therapy is administered
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Summers, MD
Organizational Affiliation
Seattle Children's Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase 1 Study of CD22-CAR TCell Immunotherapy for CD22+ Leukemia and Lymphoma

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