CD19x22 CAR T-cell Therapy for Pediatric B-ALL
This study is testing a new type of cell therapy called CD19x22 CAR T for children and young adults (ages 3 months to 30 years) with B-cell Acute Lymphoblastic Leukemia (B-ALL) that has come back or hasn't responded to other treatments. This therapy uses your own immune cells, called T-cells, which are specially modified to recognize and fight cancer cells. The main goal is to see how safe the CD19x22 CAR T therapy is and if it causes any serious side effects in the first 28 days after treatment. You might be able to join if your B-ALL has relapsed two or more times, relapsed after a bone marrow transplant, or relapsed after a different CAR T-cell therapy. The study plans to enroll up to 53 patients, but the current recruitment status is unclear.
- Study design
- This is an open-label Phase I study with two groups of patients, enrolling up to 53 participants. It will determine the safety and tolerability of the CD19x22 CAR T therapy.
- What's involved
- You would receive chemotherapy to prepare your body, followed by the CD19x22 CAR T cell infusion. You will be monitored for side effects for up to 28 days after the infusion.
- Compensation
- Not stated in the trial record.
- Follow-up
- Safety will be measured up to 28 days after the infusion date.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
CD19x22 Chimeric Antigen Receptor T-cell Therapy (CAR T) in Pediatric B-ALL
At a glance
Conditions
NCT06559189
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Children's Hospital Colorado
Aurora, Coloradostudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Vanessa Fabrizio, MD · PRINCIPAL_INVESTIGATOR · University of Colorado, Denver
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Safety Measured by Dose Limiting Toxicities (DLTs)Infusion date to 28 days post-infusion
The safety of the administering this bispecific CD19/CD22-directed CAR T cell product will be measured by assessing the DLTs in each disease burden cohort in a Bayesian optimal interval (BOIN) design to determine the MTD