Skip to content
TrialMatch
Sign up
Recruiting Phase 1

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

Create a profile to match View the full record on ClinicalTrials.gov

About this study

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.

Condition
Acute Lymphoblastic Leukemia, Recurrent Acute Lymphoblastic Leukemia, Recurrent B Acute Lymphoblastic Leukemia
Tested
Fludarabine, Cyclophosphamide, Mesna, CD19-CD22 CAR T cell infusion
Sponsor
St. Jude Children's Research Hospital

Who can join

Age
Up to 21 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 27

  • Maximum age: 21 years
  • Study condition: Acute Lymphoblastic Leukemia, Recurrent Acute Lymphoblastic Leukemia, Recurrent B Acute Lymphoblastic Leukemia
  • Collection and Manufacturing Eligibility
  • 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
  • Age \< 21 years old
  • Detectable 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
  • If sexually active, agreement to use birth control until 3 months after T cell infusion. Male partners should use a condom.

Exclusion 10

  • Known primary immunodeficiency
  • Known HIV positivity
  • Known contraindication to receiving protocol defined lymphodepleting
  • chemotherapy regimen
  • History of hypersensitivity reaction to murine protein-containing products
  • Treatment Eligibility
  • 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

Where

1 site, 1 recruiting

St. Jude Children's Research Hospital

Memphis, Tennessee, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.