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

NCT04571138 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PLAT-07
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 4

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.

Conditions

Leukemia; Lymphoma

Outcome Measures

Primary Outcomes (3)

• The adverse events associated with CAR T cell product infusions will be assessed

  The type, frequency, severity, and duration of adverse events will be summarized

  28 days post-infusion

• The ability to successfully manufacture SCRI-CAR22v2

  We will measure the number of successfully manufactured SCRI-CAR22v2 products

  28 days

• 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

  28 days post-infusion

Study Arms (1)

SCRI-CAR22v2

EXPERIMENTAL

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

Biological: SCRI-CAR22v2

Interventions

SCRI-CAR22v2 BIOLOGICAL

Single infusion of SCRI-CAR22v2

SCRI-CAR22v2

Eligibility Criteria

• Age: Up to 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (4)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

MeSH Terms

Conditions

Leukemia; Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System 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: September 2, 2020
• First Posted: September 30, 2020
• Study Start: September 25, 2020
• Primary Completion: August 8, 2025
• Study Completion (Estimated): February 1, 2040
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (4)