Phase 1/2 Study of UCART22 for Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia
This study is testing a new treatment called UCART22 for people aged 15 to 50 with B-cell Acute Lymphoblastic Leukemia (B-ALL) that has come back or hasn't responded to previous treatments. UCART22 is a type of cell therapy where your own immune cells are specially modified to fight cancer. You would receive UCART22 after a short course of other medicines (CLLS52) to prepare your body. To join, your B-ALL cells must have a specific marker called CD22, and you must have already tried at least two types of chemotherapy. The main goals are to see how safe UCART22 is, find the best dose, and check if it helps treat the leukemia. This is the first time UCART22 is being tested in humans, and it is currently enrolling participants.
- Study design
- This is a first-in-human, open-label study, meaning both you and the study team will know which treatment you are receiving. It involves increasing doses to find the safest and most effective amount of UCART22, with a planned enrollment of 52 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your safety and side effects will be monitored for up to 24 months after treatment. Dose-limiting toxicities will be assessed up to 28 days after your first UCART22 infusion.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Phase 1/2 Study of UCART22 in Patients With Relapsed or Refractory CD22+ B-cell Acute Lymphoblastic Leukemia (BALLI-01)
At a glance
Conditions
NCT04150497
Where you'd take part
This study runs at 19 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Children's Hospital of Philadelphia
Philadelphia, Pennsylvaniano site contact published
Recruiting
CHU de Nantes - Hôtel-Dieu
Nantes, Franceno site contact published
Recruiting
CHU Rennes - Hopital Pontchaillou
Rennes, Franceno site contact published
Recruiting
Dana Farber Cancer Institute
Boston, Massachusettsno site contact published
Recruiting
Hôpital Lyon Sud
Pierre-Bénite, Franceno site contact published
Recruiting
Hôpital Robert Debré - Service d'hémato-immunologie
Paris, Franceno site contact published
Recruiting
Hôpital Saint Louis, Unité d'Hématologie Adolescents et Jeunes Adultes Département d'Hématologie
Paris, Franceno site contact published
Recruiting
MD Anderson Cancer Center
Houston, Texasno site contact published
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
- Nitin Jain, MD · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Incidence of AE/SAE/DLT [Safety and Tolerability]24 Months
Incidence, nature, and severity of adverse events and serious adverse events (SAEs) throughout the study in relation to UCART22 and/or lymphodepletion
- Dose escalation part: Occurrence of Dose Limiting Toxicities (DLTs)Up to D28 post initial UCART22 infusion