RECRUITING

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

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Conditions

Acute Lymphoblastic LeukemiaRecurrent Acute Lymphoblastic LeukemiaRefractory Lymphoblastic LymphomaRecurrent B Acute Lymphoblastic LeukemiaRefractory B Lymphoblastic Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-05
Study Completion:2031-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06777979

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.

Ages Eligible for Study:Not specified to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \<21 years old
  2. * Relapsed/refractory CD19- and/or CD22-positive acute leukemia defined as:
  3. * Second or greater relapse
  4. * Any relapse after allogeneic HCT
  5. * Refractory disease (primary or in relapse) despite therapy designed to induce remission
  6. * Estimated life expectancy of \> 12 weeks
  7. * Karnofsky or Lansky (age-dependent) performance score ≥50 (Appendix A)
  8. * For females of childbearing age:
  9. * Not lactating with intent to breastfeed
  10. * Not pregnant with negative serum or urine pregnancy test within 7 days prior to enrollment
  1. * Known primary immunodeficiency
  2. * Known HIV positivity
  3. * Known contraindication to receiving protocol defined lymphodepleting
  4. * chemotherapy regimen
  5. * History of hypersensitivity reaction to murine-containing products

Contacts and Locations

Study Contact

Rebecca Epperly, MD
CONTACT
8662785833
referralinfo@stjude.org

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: St. Jude Children's Research Hospital

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05
Study Completion Date2031-01

Study Record Updates

Study Start Date2025-05
Study Completion Date2031-01

Terms related to this study

Additional Relevant MeSH Terms

  • Acute Lymphoblastic Leukemia
  • Recurrent Acute Lymphoblastic Leukemia
  • Refractory Lymphoblastic Lymphoma
  • Recurrent B Acute Lymphoblastic Leukemia
  • Refractory B Lymphoblastic Lymphoma