CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia

Description

This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells. Primary Objective: To determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent/refractory CD19- and/or CD22-positive leukemia. Secondary Objective: To evaluate the anti-leukemic activity of CD19-CD22-CAR T cells.

Conditions

Acute Lymphoblastic Leukemia, Recurrent Acute Lymphoblastic Leukemia, Refractory Lymphoblastic Lymphoma, Recurrent B Acute Lymphoblastic Leukemia, Refractory B Lymphoblastic Lymphoma

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Study Overview

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Study Details

Study overview

This study is a phase I study designed to evaluate the safety of CD19-CD22-CAR T cells. Primary Objective: To determine the safety profile and propose the recommended phase 2 dose (RP2D) of autologous CD19-CD22-CAR T cells in patients ≤ 21 years of age with recurrent/refractory CD19- and/or CD22-positive leukemia. Secondary Objective: To evaluate the anti-leukemic activity of CD19-CD22-CAR T cells.

CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia (1922CAR)

CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia

Condition
Acute Lymphoblastic Leukemia
Intervention / Treatment

-

Contacts and Locations

Memphis

St. Jude Children's Research Hospital, Memphis, Tennessee, United States, 38105

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Age \<21 years old
  • * Relapsed/refractory CD19- and/or CD22-positive acute leukemia defined as:
  • * Second or greater relapse
  • * Any relapse after allogeneic HCT
  • * Refractory disease (primary or in relapse) despite therapy designed to induce remission
  • * Estimated life expectancy of \> 12 weeks
  • * Karnofsky or Lansky (age-dependent) performance score ≥50 (Appendix A)
  • * For females of childbearing age:
  • * Not lactating with intent to breastfeed
  • * Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment
  • * Known primary immunodeficiency
  • * Known HIV positivity
  • * Known contraindication to receiving protocol defined lymphodepleting
  • * chemotherapy regimen
  • * History of hypersensitivity reaction to murine-containing products

Ages Eligible for Study

to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

St. Jude Children's Research Hospital,

Rebecca Epperly, MD, PRINCIPAL_INVESTIGATOR, St. Jude Children's Research Hospital

Study Record Dates

2031-01