CD19-specific CAR T Cells With a Fully Human Binding Domain for CD19+ Leukemia or Lymphoma

NCT03684889 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PLAT-06
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 2

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 fully human chimeric antigen receptor (CAR). The CAR used in this study can recognize CD19, a protein expressed on the surface of leukemia and lymphoma cells. The fully human CAR used in this study may help protect against rejection of the CAR T cells, which in turn could lead to lasting protection against return of the leukemia or lymphoma. The phase 1 part of this study will determine the safety 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

Keywords

CAR T cell, CD19, pediatric, young adults

Outcome Measures

Primary Outcomes (2)

• 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

  30 days

• The leukemia response to SCRI-huCAR19 in subjects with relapsed or refractory CD19+ leukemia will be assessed

  Response will be defined by standard bone marrow assessment and standard response criteria

  63 days

Study Arms (2)

SCRI-huCAR19v2

EXPERIMENTAL

Patients will receive SCRI-huCAR19v2 in either Phase 1 or Phase II

Biological: SCRI-huCAR19v2

SCRI-huCAR19v1 - [CLOSED]

EXPERIMENTAL

Patients will receive SCRI-huCAR19v1 in either Phase 1 or Phase II. As of 02/13/2020 this study cohort is permanently closed.

Biological: SCRI-huCAR19v1

Interventions

SCRI-huCAR19v1 BIOLOGICAL

1:1 mixture of CD4:CD8 autologous T cells lentivirally transduced to express a second generation 4-1BB-ζ human CD19-specific CAR and Her2tG

SCRI-huCAR19v1 - [CLOSED]

SCRI-huCAR19v2 BIOLOGICAL

Mixture of CD4:CD8 autologous T cells lentivirally transduced to express a second generation 4-1BB-ζ human CD19-specific CAR and Her2tG

SCRI-huCAR19v2

Eligibility Criteria

• Age: 1 Year - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male and female subjects age ≥ 1 and ≤ 30 years
• First 2 enrolled subjects: age ≥ 18 and ≤ 30 years
• Disease requirements:
• Phase 1: Evidence of refractory or recurrent CD19+ leukemia or lymphoma following previous CAR T cell immunotherapy
• Phase 2: Evidence of refractory or recurrent CD19+ leukemia or lymphoma
• Able to tolerate apheresis, or has 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
• No prior virotherapy
• ≥ 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

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
• 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 patient from undergoing treatment under this protocol

Sponsors & Collaborators

• Seattle Children's Hospital: lead

Study Sites (2)

Children's Hospital Los Angeles

Los Angeles, California, 90027, 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

• Colleen Annesley, MD

  Seattle Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• 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 17, 2018
• First Posted: September 26, 2018
• Study Start: November 28, 2018
• Primary Completion: February 8, 2021
• Study Completion (Estimated): December 1, 2036
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)