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

Launched by ST. JUDE CHILDREN'S RESEARCH HOSPITAL · Jan 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CD19-CD22-Bispecific CAR T Cell Therapy for children and young adults up to 21 years old who have certain types of leukemia, specifically Acute Lymphoblastic Leukemia (ALL) that has come back or hasn’t responded to other treatments. The main goal of the study is to find out if this therapy is safe and to determine the best dose to use in future studies. Additionally, researchers want to see how well this treatment works against the leukemia.

To be eligible for the trial, participants must be under 21 years old and have leukemia that tests positive for specific markers (CD19 and/or CD22). They should also have a life expectancy of more than 12 weeks and meet certain health criteria, such as having adequate heart and kidney function. Participants can expect to receive the CAR T cell therapy, and the study will closely monitor their health and any side effects. It’s important to know that there are some criteria that would exclude someone from participating, such as having certain infections or other health conditions. This trial is currently recruiting participants.

Gender

ALL

Eligibility criteria

• • Collection and Manufacturing Eligibility
• Inclusion Criteria:
• • Age \<21 years old
• * Relapsed/refractory CD19- and/or CD22-positive acute leukemia defined as:
• • \*CD19 and/or CD22-positivity confirmed within 2 months and after receipt of any CD19 or CD22-directed therapy
• • 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
• Exclusion Criteria:
• • Known primary immunodeficiency
• • Known HIV positivity
• • Known contraindication to receiving protocol defined lymphodepleting
• • chemotherapy regimen
• • History of hypersensitivity reaction to murine-containing products
• • Treatment Eligibility
• Inclusion Criteria:
• • Age \< 21 years old
• • Detectable CD19- and/or CD22-positive leukemic disease in the bone marrow
• • Estimated life expectancy of \> 8 weeks
• • Karnofsky or Lansky (age-dependent) performance score \> 50 (Appendix A)
• • Adequate cardiac function defined as left ventricular ejection fraction \>40%, or shortening fraction \> 25%
• • EKG without evidence of clinically significant arrhythmia
• • Adequate renal function defined as creatinine clearance or radioisotope GFR \>50 mL/min/1.73m2 (GFR \>40 mL/min/1.73m2 if \<2 years of age)
• • Adequate pulmonary function defined as forced vital capacity (FVC) \>50% of predicted value; or pulse oximetry \>92% on room air
• • Total bilirubin \< 3 times the upper limit of normal for age, except in subjects with Gilbert's syndrome
• • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \< 5 times the upper limit of normal for age
• • Has recovered from all NCI CTAE grade III-IV, non-hematologic acute toxicities from prior therapy
• • Prior to planned CAR T cell infusion, patients with a history of prior allogeneicHCT must be at least 3 months from HCT, have no evidence of acute GVHD, and have not received a donor lymphocyte infusion (DLI) within the 28 daysprior to planned infusion
• * 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
• • If sexually active, agreement to use birth control until 3 months after T cell infusion. Male partners should use a condom.
• Exclusion Criteria:
• • Known primary immunodeficiency
• • Known HIV positivity
• • Known contraindication to receiving protocol defined lymphodepleting
• • chemotherapy regimen
• • History of hypersensitivity reactions to murine protein-containing products
• • Severe, uncontrolled bacterial, viral or fungal infection
• • Active CNS-3 disease
• • Evidence of active, uncontrolled neurologic disease