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New treatment option for Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia
Official title 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)
ClinicalTrials.gov ID: NCT06173518
What this study is testing
What is AUTO1?
AUTO1 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for relapsed or refractory b cell acute lymphoblastic leukemia.
Also referred to as Obecabtagene autoleucel (obe-cel).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 18
You may be able to join 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...
- 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...
- Adequate renal, hepatic, pulmonary, and cardiac function.
You likely can't join 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.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
- San Antonio, Texas, United States
- Salt Lake City, Utah, United States
- Barcelona, Spain
- Madrid, Spain
- London, United Kingdom
- Manchester, United Kingdom
- Newcastle upon Tyne, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States; San Antonio, Texas, United States; Salt Lake City, Utah, United States; Barcelona, Spain; Madrid, Spain; London, United Kingdom and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.