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A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD22 for Relapsed/Refractory Leukemia or Lymphoma

Primary Purpose

Leukemia, Lymphoma

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
SCRI-CAR22v2
Sponsored by
Seattle Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia

Eligibility Criteria

undefined - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Male and female subjects aged ≤ 30 years. First 2 enrolled subjects: age ≥ 18 and ≤ 30 years
  • Evidence of refractory or recurrent CD22+ leukemia or lymphoma
  • Able to tolerate apheresis, or subject with sufficient existing apheresis product or T cells for manufacturing investigational product.
  • Life expectancy ≥ 8 weeks
  • Lansky or Karnofsky, as applicable, score ≥ 50
  • Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy, if the subject does not have a previously obtained apheresis product that is acceptable and available for manufacturing of CAR T cells
  • ≥ 7 days post last chemotherapy and biologic therapy, with the exception of intrathecal chemotherapy and maintenance chemotherapy
  • ≥ 7 days post last corticosteroid therapy
  • ≥ 3 days post Tyrosine Kinase Inhibitor (TKI) use
  • ≥ 1 day post hydroxyurea
  • 30 days post most recent CAR T cell infusion
  • Adequate organ function
  • Adequate laboratory values, including absolute lymphocyte count ≥ 100 cells/uL
  • Subjects of childbearing or child-fathering potential must agree to use highly effective contraception from consent through 12 months following infusion of investigational product on trial
  • Subject and/or legally authorized representative has signed the informed consent form for this study

Exclusion Criteria:

  • Presence of active malignancy other than disease under study
  • History of symptomatic CNS pathology or ongoing symptomatic CNS pathology
  • CNS involvement of leukemia or lymphoma that is symptomatic and in the opinion of the investigator, cannot be controlled during the interval between enrollment and CAR T cell infusion
  • Subjects with uniform expression of CD19 on their malignant cells who are eligible but have not attempted CD19 directed CAR T cell therapy
  • For subjects having had a previous stem cell transplant: presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment
  • Presence of active severe infection,
  • Presence of primary immunodeficiency syndrome
  • Subject has received prior virotherapy
  • Pregnant or breastfeeding
  • Subject and/or legally authorized representative unwilling to provide consent/assent for participation in the 15-year follow-up period, required if CAR T cell therapy is administered
  • Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol

Sites / Locations

  • Children's Hospital Los AngelesRecruiting
  • Children's National HospitalRecruiting
  • Riley Hospital for ChildrenRecruiting
  • Texas Children's HospitalRecruiting
  • Seattle Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SCRI-CAR22v2

Arm Description

Patients will receive SCRI-CAR22v2 in either Phase I or Phase II

Outcomes

Primary Outcome Measures

he adverse events associated with CAR T cell product infusions will be assessed
The type, frequency, severity, and duration of adverse events will be summarized
The ability to successfully manufacture SCRI-CAR22v2
We will measure the number of successfully manufactured SCRI-CAR22v2 products
The leukemia response to SCRI-CAR22v2 in subjects with relapsed or refractory CD22+ leukemia will be assessed
The efficacy of the T cell infusion will be estimated based on the number of participants who have an MRD negative bone marrow aspirate following the T cell infusion

Secondary Outcome Measures

Full Information

First Posted
September 2, 2020
Last Updated
June 27, 2023
Sponsor
Seattle Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04571138
Brief Title
A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD22 for Relapsed/Refractory Leukemia or Lymphoma
Official Title
Pediatric and Young Adult Leukemia Adoptive Therapy (PLAT)-07: A Phase 1/2 Study of CD22-Specific CAR T Cells for CD22+ Leukemia or Lymphoma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 25, 2020 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
February 2039 (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 or lymphoma are often refractory to further chemotherapy. In this study, the investigators will attempt to use T cells obtained directly from the patient, which can be genetically engineered to express a chimeric antigen receptor (CAR). The CAR used in this study can recognize CD22, a protein expressed on the surface of leukemia and lymphoma cells. The phase 1 part of this study will determine the safety and appropriate dose level of these CAR T cells, and the phase 2 part of the study will determine how effective this CAR T cell therapy is. Both patients who have never had prior CAR T cell therapy and those who have had prior CAR T cell therapy may be eligible to participate in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Lymphoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
SCRI-CAR22v2
Arm Type
Experimental
Arm Description
Patients will receive SCRI-CAR22v2 in either Phase I or Phase II
Intervention Type
Biological
Intervention Name(s)
SCRI-CAR22v2
Intervention Description
Single infusion of SCRI-CAR22v2
Primary Outcome Measure Information:
Title
he adverse events associated with CAR T cell product infusions will be assessed
Description
The type, frequency, severity, and duration of adverse events will be summarized
Time Frame
28 days post-infusion
Title
The ability to successfully manufacture SCRI-CAR22v2
Description
We will measure the number of successfully manufactured SCRI-CAR22v2 products
Time Frame
28 days
Title
The leukemia response to SCRI-CAR22v2 in subjects with relapsed or refractory CD22+ leukemia will be assessed
Description
The efficacy of the T cell infusion will be estimated based on the number of participants who have an MRD negative bone marrow aspirate following the T cell infusion
Time Frame
28 days post-infusion

10. Eligibility

Sex
All
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female subjects aged ≤ 30 years. First 2 enrolled subjects: age ≥ 18 and ≤ 30 years Evidence of refractory or recurrent CD22+ leukemia or lymphoma Able to tolerate apheresis, or subject with sufficient existing apheresis product or T cells for manufacturing investigational product. Life expectancy ≥ 8 weeks Lansky or Karnofsky, as applicable, score ≥ 50 Recovered from acute toxic effects of all prior chemotherapy, immunotherapy, and radiotherapy, if the subject does not have a previously obtained apheresis product that is acceptable and available for manufacturing of CAR T cells ≥ 7 days post last chemotherapy and biologic therapy, with the exception of intrathecal chemotherapy and maintenance chemotherapy ≥ 7 days post last corticosteroid therapy ≥ 3 days post Tyrosine Kinase Inhibitor (TKI) use ≥ 1 day post hydroxyurea 30 days post most recent CAR T cell infusion Adequate organ function Adequate laboratory values, including absolute lymphocyte count ≥ 100 cells/uL Subjects of childbearing or child-fathering potential must agree to use highly effective contraception from consent through 12 months following infusion of investigational product on trial Subject and/or legally authorized representative has signed the informed consent form for this study Exclusion Criteria: Presence of active malignancy other than disease under study History of symptomatic CNS pathology or ongoing symptomatic CNS pathology CNS involvement of leukemia or lymphoma that is symptomatic and in the opinion of the investigator, cannot be controlled during the interval between enrollment and CAR T cell infusion Subjects with uniform expression of CD19 on their malignant cells who are eligible but have not attempted CD19 directed CAR T cell therapy For subjects having had a previous stem cell transplant: presence of active GVHD, or receiving immunosuppressive therapy for treatment or prevention of GVHD within 4 weeks prior to enrollment Presence of active severe infection, Presence of primary immunodeficiency syndrome Subject has received prior virotherapy Pregnant or breastfeeding Subject and/or legally authorized representative unwilling to provide consent/assent for participation in the 15-year follow-up period, required if CAR T cell therapy is administered Presence of any condition that, in the opinion of the investigator, would prohibit the subject from undergoing treatment under this protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Corinne Summers, MD
Phone
206-987-2106
Email
CBDCIntake@seattlechildrens.org
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
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lee Chen
First Name & Middle Initial & Last Name & Degree
Emily Hsieh, MD
Facility Name
Children's National Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anant Vatsayan, MD
First Name & Middle Initial & Last Name & Degree
Anant Vatsayan, MD
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jodi Skiles, MD
First Name & Middle Initial & Last Name & Degree
Jodi Skiles, MD
Facility Name
Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rayne Rouce, MD
First Name & Middle Initial & Last Name & Degree
Rayne Rouce, MD
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corinne Summers, MD
Phone
206-987-2106
Email
CBDCIntake@seattlechildrens.org
First Name & Middle Initial & Last Name & Degree
Corinne Summers, MD

12. IPD Sharing Statement

Learn more about this trial

A Pediatric and Young Adult Trial of Genetically Modified T Cells Directed Against CD22 for Relapsed/Refractory Leukemia or Lymphoma

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