NCT06173518 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)
| NCT ID | NCT06173518 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Autolus Limited |
| Condition | Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-11-16 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2023-11-16 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06173518 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 18 Years, studying Relapsed or Refractory B Cell Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06173518 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06173518 currently recruiting?
Yes, NCT06173518 is actively recruiting participants. Contact the research team at clinicaltrials@autolus.com for enrollment information.
Where is the NCT06173518 trial being conducted?
This trial is being conducted at Los Angeles, United States, Palo Alto, United States, Aurora, United States, Atlanta, United States and 11 additional locations.
Who is sponsoring the NCT06173518 clinical trial?
NCT06173518 is sponsored by Autolus Limited. The trial plans to enroll 30 participants.
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