CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fludarabine, Cyclophosphamide, Mesna, CD19-CD22 CAR T cell infusion.
- Who it may be relevant to
- Registry conditions: Acute Lymphoblastic Leukemia, Recurrent Acute Lymphoblastic Leukemia, Recurrent B Acute Lymphoblastic Leukemia. Basic parameters: up to 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia (1922CAR)
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.
Detailed description
Treatment will include a single course of lymphodepleting chemotherapy (fludarabine/cyclophosphamide) followed by CAR T cell infusion. CAR T cell dose will be determined by the protocol-defined dose escalation scheme, based on the number of CAR+ T cells and participant weight.
Interventions
- Drug Fludarabine
IV - Drug Cyclophosphamide
IV - Drug Mesna
IV - Device CD19-CD22 CAR T cell infusion
CAR T cell infusion will be given intravenously, either centrally or peripherally.
Primary outcome measures
- Recommended phase 2 dose (RP2D) of CD19-CD22-CAR T cells [Time frame: up to 4 weeks after CD19-CD22-CAR T-cell infusion]
- Incidence of adverse events [Time frame: up to 4 weeks after CD19-CD22-CAR T-cell infusion]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- St. Jude Children's Research Hospital — Memphis
Identifiers
NCT: NCT06777979 · 1922CAR · NCI-2024-10103