A Study of CD19 Targeted CAR T Cell Therapy in Pediatric Patients With Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia (B ALL) and Aggressive Mature B-cell Non-Hodgkin Lymphoma (B NHL)
Recruiting now · Phase 1
Conditions studied: Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia, Relapsed or Refractory B Cell Non-Hodgkin Lymphoma
In brief
This is a Phase 1b/2 study to evaluate the safety and efficacy of autologous T cells engineered with a chimeric antigen receptor (CAR) targeting cluster of differentiation (CD)19 in pediatric patients with relapsed or refractory (r/r) B cell acute lymphoblastic leukemia (B ALL) and r/r B cell Non-Hodgkin lymphoma (B NHL).
Key facts
- Study ID
- NCT06173518
- Run by
- Autolus Limited
- People needed
- 30
- Starts
- 2023-11-16
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-03-02
Who can join
Age: any, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- < 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.
You may not qualify if…
- 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 it is running
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)
- Methodist Children's Hospital — San Antonio, Texas, United States (enrolling)
- Primary Children's Hospital — Salt Lake City, Utah, United States (enrolling)
- Hospital Vall d'Hebron — Barcelona, Spain (enrolling)
- Hospital Nino Jesus — Madrid, Spain (enrolling)
- Great Ormond Street Hospital for Children NHS Foundation Trust — London, United Kingdom (enrolling)
- Royal Manchester Children's Hospital — Manchester, United Kingdom (enrolling)
- Great North Children's Hospital — Newcastle upon Tyne, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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