CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescen… (NCT07328503) | Clinical Trial Compass
RecruitingPhase 2
CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia
United States20 participantsStarted 2026-06-16
Plain-language summary
Background:
Acute lymphoblastic leukemia (ALL) is a type of blood cancer. Chimeric antigen receptor (CAR) therapy involves taking immune cells (T cells) from a person and modifying them to better target cancer cells. CAR T-cell therapy that targets a marker called CD19 has been show to can cure ALL in many children and adults. But in about 50% of patients, the ALL comes back within a year. Researchers want to find out if a second treatment with CAR T-cell therapy that targets a different marker, CD22, can keep the cancer away longer.
Objective:
To see if CD22 CAR T-cell therapy can keep ALL away longer.
Eligibility:
People aged 3 to 65 years who have no signs of cancer after CD19 CAR T-cell treatment for ALL.
Design:
Participants will be screened. They will have imaging scans and tests of their heart function. A sample of tissue (biopsy) will be collected from their bone marrow. They will have a fluid sample collected from the area around their spinal cord.
Participants will undergo collection of their white blood cells (T cells) during a procedure called leukapheresis. Blood will be taken from their body through a vein. The blood will pass through a machine that separates out the T cells. The remaining blood will be returned to the body through a different vein. The cells will be altered in a lab to create CD22 CAR T-cell therapy.
Participants will take drugs over 4 consecutive days to prepare their body for the CAR T-cell therapy; then they will receive their modified T cells through a tube inserted into a vein. Some people may need to stay in the hospital during treatment.
Participants will have follow-up visits for 2 years.
Who can participate
Age range
3 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* INCLUSION CRITERIA:
* Participants must have documentation of pathologic confirmation of a diagnosis of relapsed/refractory B cell acute lymphoblastic leukemia (ALL).
* History of CD19 and CD22 expression on malignant cells at diagnosis or relapse.
* Age between \>= 3 years and \<= 65 years
* Participants must have received an FDA-approved CD19 CAR T-cell construct for treatment of B cell ALL within the time period of \>= 2 months and \<= 7 months prior to apheresis or lymphodepleting (LD) (if apheresis is not done on this protocol).
* Must be in an MRD-negative remission as demonstrated by flow cytometry at screening.
* Must be ineligible for or unwilling to undergo allogeneic stem cell transplant (SCT).
* Clinical performance status (PS): Karnofsky \>= 50% (participants \>= 16 years of age), or Lansky scale \>= 50% (participants \< 16 years of age). Participants who are unable to walk because of paralysis, but who are upright in a wheelchair may be considered eligible.
* Must have no ongoing signs of CRS from prior CAR T cell infusion and/or ICANs at screening.
* Participants must have adequate organ function as defined below:
* Total bilirubin \<= 2 x institutional upper limit of normal (ULN)
* Aspartate Aminotransferase (AST) \<= 10 x ULN
* Alanine Aminotransferase (ALT) \<= 10 x ULN
* creatinine \<= the maximum for age listed below OR measured creatinine clearance \>= 60 mL/min/1.73 m\^2 for participants with
creatinine levels above the max
* Age: \<=5, Maxi…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this trial uses CD22 CAR T-cells after a patient has already received commercial CD19 CAR T-cells, would my treatment history with CD19 CAR T-cell therapy make me a candidate worth discussing for this study?
2This is a Phase 2 trial, which means researchers already have some early safety data — what do we know so far about the risks of receiving a second CAR T-cell therapy targeting a different protein like CD22?
3The trial is measuring whether patients stay in remission for one year — how does that 1-year recurrence-free survival goal compare to what I might expect from other available options after a relapse?
4Given that this trial involves CAR T-cell therapy on top of prior CAR T-cell treatment, what kinds of side effects or immune-related complications should I be prepared for that might be unique to this sequential approach?
5How would participating in this trial affect my ability to pursue other treatments or clinical trials if my leukemia were to come back again while I'm enrolled?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.