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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title CD19x22 Chimeric Antigen Receptor T-cell Therapy (CAR T) in Pediatric B-ALL
ClinicalTrials.gov ID: NCT06559189
What this study is testing
What is CD19x22 CAR T?
CD19x22 CAR T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell acute lymphoblastic leukemia.
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 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.
- 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 3 to 30
You may be able to join if
- people must have a history of B precursor ALL with any of the following conditions:
- Relapsed two or more times.
- Relapsed at any time after allogeneic bone marrow transplant (BMT).
- Relapse or refractory after single antigen targeting CAR T cell therapy. i. 90 days must have elapsed post previous CAR infusion prior to apheresis...
- CD19 and/or CD22 present on last relapsed/refractory disease evaluation.
You likely can't join if
- Active, uncontrolled central nervous system (CNS) leukemia that is progressive despite other therapies or leading to CNS symptoms (including but not...
- History of allogeneic stem cell transplantation prior to apheresis that meet the following criteria:
- Less than 100 days post-transplant;
- Evidence of active Graft-versus-Host Disease (GvHD) requiring systemic therapy;
- Less than 6 weeks post donor lymphocyte infusion (DLI).
- Active, uncontrolled, life-threatening infection that at the determination of the treating physician would preclude safe apheresis or tolerance of...
See the full eligibility criteria
- people must have a history of B precursor ALL with any of the following conditions:
- Relapsed two or more times.
- Relapsed at any time after allogeneic bone marrow transplant (BMT).
- 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...
- CD19 and/or CD22 present on last relapsed/refractory disease evaluation.
- Performance score (Lansky or Karnofsky ≥ 50%; or Eastern Cooperative Oncology Group (ECOG) must be ≤2).
- Meets criteria for potential leukapheresis collection or has leukapheresis product previously collected and stored per recommended guidelines.
- Males OR non-pregnant, non-lactating females.
- Aged 3 months to 30 years (inclusive) at time of consent and enrollment.
- Provision of a signed and dated consent form from parent or guardian (patients \ 18), or legally authorized representative (patient \> 18 who lack decision-making capacity) after standard of care (SOC) screening...
- Stated willingness to comply with all study procedures and be available for the duration of the study.
- Willingness to participate in long-term follow-up protocol.
- 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...
- History of allogeneic stem cell transplantation prior to apheresis that meet the following criteria:
- Less than 100 days post-transplant;
- Evidence of active Graft-versus-Host Disease (GvHD) requiring systemic therapy;
- Less than 6 weeks post donor lymphocyte infusion (DLI).
- 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...
- Evidence of severe organ dysfunction defined by:
- Baseline oxygen saturation of \< 90% on room air
- 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...
- Transaminases \> 10x upper limit of normal (ULN) or bilirubin \> 5x the ULN, unless thought to be related to primary disease
- 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)
- people 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
- Known HIV infection or active Hepatitis B or Hepatitis C infection.
The study team makes the final eligibility decision.
Where it's taking place
- Aurora, Colorado, United States
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, 3 months to 30 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aurora, Colorado, United States. 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.