A Phase 1 Study of CD22-CAR TCell Immunotherapy for CD22+ Leukemia and Lymphoma (NCT03244306) | Clinical Trial Compass
CompletedPhase 1
A Phase 1 Study of CD22-CAR TCell Immunotherapy for CD22+ Leukemia and Lymphoma
United States4 participantsStarted 2017-07-27
Plain-language summary
Patients with relapsed or refractory leukemia often develop resistance to chemotherapy and some patients who relapse following CD19 directed therapy relapse with CD19 negative leukemia. For this reason, the investigators are attempting to use T-cells obtained directly from the patient, which can be genetically modified to express a chimeric antigen receptor (CAR) to CD22, a different protein from CD19, expressed on the surface of the leukemic cell in patients with CD22+ leukemia. The CAR enables the T-cell to recognize and kill the leukemic cell through the recognition of CD22, a protein expressed on the surface of the leukemic cell in patients with CD22+ leukemia. This is a Phase 1 study designed to determine the safety and feasibility of the CAR+ T - cells and the feasibility of making enough to treat patients with CD22+ leukemia.
Who can participate
Age range
1 Year – 26 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
. If post-allogeneic hematopoetic cell transplant (HCT): confirmed CD22+ leukemia recurrence, defined as ≥0.01% disease
. If Relapse/Refractory status with no prior history of allogeneic HCT, one of:
. CD22+ Lymphoma refractory or relapsed with no known curative therapies available
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 is a Phase 1 trial that has already completed, what safety findings or adverse events were reported from the CD22-CAR T-cell infusions, and how might those risks apply to my specific situation?
2This trial focused on measuring manufacturing success rates for the CAR T-cell products — can you tell me how often the T-cell products were successfully made and infused, and what happens if manufacturing fails for a patient like me?
3Given that this trial targeted CD22-positive leukemia, would my leukemia first need to be tested for CD22 expression, and what does that result mean for whether this or a similar treatment could even be considered for me?
4Since this Phase 1 study is now completed, are there follow-on Phase 2 trials or expanded access programs for CD22-CAR T-cell therapy that might be open to me, or is this approach still too early-stage compared to standard treatments?
5How does CD22-targeted CAR T-cell therapy compare to the standard treatment options available to me right now, and would it make sense to try standard therapies first before considering an experimental approach like this one?
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.
What they're measuring
1
The adverse events associated with one or multiple CAR T-cell product infusions will be assessed
Timeframe: 30 days
2
The number of successfully and unsuccessfully manufactured and infused CAR T-cell products will be assessed