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ACTIVE_NOT_RECRUITINGPHASE1

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

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

NCT03244306•Seattle Children's Hospital

View on ClinicalTrials.gov

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.

Eligibility

Age

1 - 26 years

Sex

ALL

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
+12 more criteria

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

Locations (1)

Seattle Children's Hospital

Seattle, Washington, United States

Key Dates

Start Date

July 27, 2017

Primary Completion Date

November 14, 2018

Completion Date

July 1, 2035

Last Updated

June 17, 2025

Enrollment

ACTUAL participants

Conditions

Leukemia

Interventions

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

BIOLOGICAL

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

NCT00106925

Graft-versus-leukemiaGraft vs Host Disease+1 more

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RECRUITINGPHASE2

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

NCT06311227

Recurrent Hairy Cell LeukemiaRecurrent Hairy Cell Leukemia Variant

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 17, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Long-term Evaluation and Follow-up Care of Patients Treated With Stem Cell Transplants

Venetoclax for the Treatment of Patients With Relapsed Hairy Cell Leukemia

Phase I Study of HC-7366 for Acute Myeloid Leukemia

Azacitidine and Abatacept in Relapsed or Refractory T-Cell Lymphoma

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A Study of Bleximenib, Venetoclax and Azacitidine For Treatment of Participants With Newly Diagnosed Acute Myeloid Leukemia (AML)