CD19 targeted CAR T cell therapy for children with relapsed or refractory B cell leukemia and lymphoma
A Single-Arm, Open-Label, Multicenter, Phase 1b/2 Study Evaluating the Safety and Efficacy of AUTO1 (Obecabtagene Autoleucel [Obe-cel]) in Pediatric Patients With CD19-positive Relapsed/Refractory (R/R) B Cell Acute Lymphoblastic Leukemia (B ALL) or R/R Aggressive Mature B Cell Non-Hodgkin Lymphoma (B NHL).
This study is testing a new CAR T cell therapy for children with tough-to-treat B cell leukemia and lymphoma to see if it can help them feel better.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | Autolus Limited Industry-sponsored |
| Drugs / interventions | blinatumomab, chimeric antigen receptor |
| Locations | 8 sites (Philadelphia, Pennsylvania and 7 other locations) |
| Trial ID | NCT06173518 on ClinicalTrials.gov |
What this trial studies
This Phase Ib study evaluates the safety and preliminary efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19 in pediatric patients with relapsed or refractory B cell acute lymphoblastic leukemia (B ALL) and aggressive mature B-cell non-Hodgkin lymphoma (B NHL). The study is single-arm and open-label, involving sequential periods of screening, leukapheresis, lymphodepletion, treatment evaluation, and follow-up. Safety data will be monitored continuously, with an Independent Data Monitoring Committee reviewing the data after specific patient milestones.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients under 18 years old with relapsed or refractory CD19-positive B ALL or B NHL.
Not a fit: Patients with non-CD19-positive malignancies or those who do not meet the age and weight criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for children with difficult-to-treat B cell malignancies.
How similar studies have performed: Other studies using CAR T cell therapy targeting CD19 have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
INCLUSION CRITERIA: * \< 18 years old at screening * ≥ 6 kg body weight at screening Pediatric patients with r/r B ALL r/r CD19-positive aggressive mature B including the B NHL subtypes: i) diffuse large B cell lymphoma, ii) Burkitt's lymphoma, iii) primary mediastinal large B cell lymphoma, iv) high-grade B cell lymphoma (not otherwise specified). * Karnofsky (age ≥ 10 years) or Lansky (age \< 10 year) performance status score ≥ 50%. * In participants with B ALL, local documentation of CD19 expression on leukemic blasts in the BM, peripheral blood, or cerebrospinal fluid or biopsy done no more than 30 days prior to consent. * Adequate renal, hepatic, pulmonary, and cardiac function. EXCLUSION CRITERIA: * Diagnosis of chronic myelogenous leukemia in lymphoid blast crisis. * History or presence of clinically relevant central nervous system (CNS) pathology unrelated to CNS leukemia. * Presence of active or uncontrolled fungal, bacterial, viral, or other infection requiring systemic antimicrobials for management. * Received prior (\< 3 months before obe cel infusion) stem cell transplantation. * Prior CD19 targeted therapy other than blinatumomab. * Experienced Grade ≥ 3 neurotoxicity following blinatumomab.
Where this trial is running
Philadelphia, Pennsylvania and 7 other locations
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Methodist Children's Hospital — San Antonio, Texas, United States (Recruiting)
- Primary Children's Hospital — Salt Lake City, Utah, United States (Recruiting)
- Hospital Vall d'Hebron — Barcelona, Spain (Recruiting)
- Hospital Nino Jesus — Madrid, Spain (Recruiting)
- Great Ormond Street Hospital for Children NHS Foundation Trust — London, United Kingdom (Recruiting)
- Royal Manchester Children's Hospital — Manchester, United Kingdom (Recruiting)
- Great North Children's Hospital — Newcastle upon Tyne, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Autolus Ltd
- Email: clinicaltrials@autolus.com
- Phone: +44 (0) 203 911 4385
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.