NCT06559189 CD19x22 Chimeric Antigen Receptor T-cell Therapy (CAR T) in Pediatric B-ALL
| NCT ID | NCT06559189 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | University of Colorado, Denver |
| Condition | B-cell Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 53 participants |
| Start Date | 2024-09-27 |
| Primary Completion | 2028-12 |
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 53 participants in total. It began in 2024-09-27 with a primary completion date of 2028-12.
⚠ 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 study will evaluate the safety and tolerability of administering a novel bispecific CD19/CD22-directed CAR T cell product (CD19x22) for the treatment of relapsed or refractory pediatric B-ALL.
Eligibility Criteria
Inclusion Criteria: 1. Subjects must have a history of B precursor ALL with any of the following conditions: 1. Relapsed two or more times. 2. Relapsed at any time after allogeneic bone marrow transplant (BMT). 3. Relapse or refractory after single antigen targeting CAR T cell therapy. i. 90 days must have elapsed post previous CAR infusion prior to apheresis. d. Refractory to standard therapy as determined by the treating physician. e. Patient and/or parents declining BMT options and would prefer CAR T Therapy. 2. CD19 and/or CD22 present on last relapsed/refractory disease evaluation. 3. Performance score (Lansky or Karnofsky ≥ 50%; or Eastern Cooperative Oncology Group (ECOG) must be ≤2). 4. Meets criteria for potential leukapheresis collection or has leukapheresis product previously collected and stored per recommended guidelines. 5. Males OR non-pregnant, non-lactating females. 6. Aged 3 months to 30 years (inclusive) at time of consent and enrollment. 7. Provision of a signed and dated consent form from parent or guardian (patients \< 18), the patient themselves (\> 18), or legally authorized representative (patient \> 18 who lack decision-making capacity) after standard of care (SOC) screening assessments are performed. 8. Stated willingness to comply with all study procedures and be available for the duration of the study. 9. Willingness to participate in long-term follow-up protocol. Exclusion Criteria: 1. Active, uncontrolled central nervous system (CNS) leukemia that is progressive despite other therapies or leading to CNS symptoms (including but not limited to: seizures, paresis, aphasia, hemorrhage, dementia, psychosis, or movement disorders) as determined by the treating physician at eligibility, prior to lymphodepleting chemotherapy (LD chemo), and pre- CD19x22 CAR T cell infusion. 2. History of allogeneic stem cell transplantation prior to apheresis that meet the following criteria: 1. Less than 100 days post-transplant; 2. Evidence of active Graft-versus-Host Disease (GvHD) requiring systemic therapy; 3. Less than 6 weeks post donor lymphocyte infusion (DLI). 3. Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe apheresis or tolerance of lymphodepleting chemotherapy, cell infusion, or increased risk of cytokine release syndrome. 4. Evidence of severe organ dysfunction defined by: 1. Baseline oxygen saturation of \< 90% on room air 2. Myocardial dysfunction (based on age standards): Ejection fraction ≤ 40% or shortening fraction ≤ 28%, evidence of physiologically significant pericardial effusion as determined by an echocardiogram (ECHO), and clinically significant electrocardiogram (ECG or EKG) findings 3. Transaminases \> 10x upper limit of normal (ULN) or bilirubin \> 5x the ULN, unless thought to be related to primary disease 4. Estimated Creatinine (Cr) clearance \< 60 mL/min/1.73 m2 (if nuclear medicine GFR or other more specific testing exceeds this level than it can supersede the estimated clearance) 5. Subjects of childbearing or child-fathering potential that are not willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the investigational product 6. Known HIV infection or active Hepatitis B or Hepatitis C infection.
Contact & Investigator
Vanessa Fabrizio, MD
PRINCIPAL INVESTIGATOR
University of Colorado, Denver
Frequently Asked Questions
Who can join the NCT06559189 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 30 Years, studying 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 NCT06559189 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 NCT06559189 currently recruiting?
Yes, NCT06559189 is actively recruiting participants. Contact the research team at BMT@childrenscolorado.org for enrollment information.
Where is the NCT06559189 trial being conducted?
This trial is being conducted at Aurora, United States.
Who is sponsoring the NCT06559189 clinical trial?
NCT06559189 is sponsored by University of Colorado, Denver. The principal investigator is Vanessa Fabrizio, MD at University of Colorado, Denver. The trial plans to enroll 53 participants.
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