CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With A… (NCT06777979) | Clinical Trial Compass
RecruitingPhase 1
CD19-CD22-Bispecific Chimeric Antigen Receptor (CAR) T Cell Therapy for Pediatric Patients With Acute Lymphoblastic Leukemia
United States30 participantsStarted 2025-04-28
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 year…
What they're measuring
1
Recommended phase 2 dose (RP2D) of CD19-CD22-CAR T cells
Timeframe: up to 4 weeks after CD19-CD22-CAR T-cell infusion
2
Incidence of adverse events
Timeframe: up to 4 weeks after CD19-CD22-CAR T-cell infusion