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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
Up to 21 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Treatment will include a single course of lymphodepleting chemotherapy (fludarabine/cyclophosphamide) followed by CAR T cell infusion."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early-stage study tests the safety of CAR T cells, made from a patient's own immune cells to target CD19 and CD22 markers on leukemia cells. It aims to find a dose for future studies and see whether the cells fight leukemia. It is for patients under age 21 whose leukemia has come back or has not responded to treatment.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be under age 21. The leukemia must have CD19 or CD22 markers confirmed within 2 months and after any treatment targeting these markers.
  • The leukemia must have come back at least twice, come back after a donor stem cell transplant, or not responded to treatment meant to clear it.
  • Before cells are collected, expected survival must be more than 12 weeks and the daily activity score must be at least 50. Before treatment, these must be more than 8 weeks and above 50.
  • Before treatment, leukemia must be found in the bone marrow, the soft tissue inside bones.
  • Before treatment, heart, kidney, lung, and liver tests must meet study limits. There must be no serious abnormal heart rhythm.
  • Before treatment, severe side effects from earlier treatment must have cleared, except those affecting blood cells.
  • If you had a donor stem cell transplant, it must be at least 3 months before CAR T treatment. You must have no acute graft-versus-host disease, where donor cells attack your body, and no donor immune cell infusion in the prior 28 days.
  • Patients who can become pregnant must have a negative pregnancy test within 7 days before enrollment and must not be producing milk with plans to breastfeed. For treatment, sexually active patients in this group must agree to birth control until 3 months afterward; male partners should use condoms.

Who can't join

  • A known immune system disorder you were born with.
  • Known HIV infection.
  • A medical reason you cannot receive the study's chemotherapy that lowers immune cell numbers.
  • A past allergic reaction to products containing mouse proteins.
  • Before treatment: a severe infection caused by bacteria, viruses, or fungi that is not controlled.
  • Before treatment: active CNS-3 disease, a study-defined level of leukemia affecting the brain or spinal cord.
  • Before treatment: an active, uncontrolled disease affecting the brain, spinal cord, or nerves.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 protein-containing products Treatment Eligibility Inclusion Criteria: * 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 * 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

Study sites (1)

TN