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

NCT03244306 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PLAT-04
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Leukemia

Keywords

leukemia; CD 22; CAR T cell; pediatric; young adult; chimeric antigen receptor

Outcome Measures

Primary Outcomes (2)

• 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

  30 days

• The number of successfully and unsuccessfully manufactured and infused CAR T-cell products will be assessed

  Proportion of products successfully manufactured and infused

  28 days

Study Arms (1)

Autologous CD22-specific CAR T-cells expressing EGFRt

EXPERIMENTAL

Biological: Patient-derived CD22-specific CAR T-cells also expressing an EGFRt

Interventions

Patient-derived CD22-specific CAR T-cells also expressing an EGFRt BIOLOGICAL

Patient-derived CD22-specific chimeric antigen receptor T-cells expressing an EGFRt

Autologous CD22-specific CAR T-cells expressing EGFRt

Eligibility Criteria

• Age: 1 Year - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• nd or grater marrow relapse, with or without extramedullary disease
• st 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Corinne Summers, MD

  Seattle Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Seattle Children's Therapeutics

Study Record Dates

• First Submitted: August 3, 2017
• First Posted: August 9, 2017
• Study Start: July 27, 2017
• Primary Completion: November 14, 2018
• Study Completion: April 17, 2024
• Last Updated: June 8, 2026

Record last verified: 2026-06

Locations

US (1)