Pilot Study of T-APCs Following CAR T Cell Immunotherapy for CD19+ Leukemia (NCT03186118) | Clinical Trial Compass
Active — Not RecruitingPhase 1
Pilot Study of T-APCs Following CAR T Cell Immunotherapy for CD19+ Leukemia
United States30 participantsStarted 2017-08-04
Plain-language summary
Patients with relapsed or refractory CD 19+ leukemia who have achieved remission after CD19 CAR-T cell treatment sometimes relapse because the CD 19 CAR-T cells decrease in number over time. Study PLAT-03 will test whether administering T cell antigen presenting cells (T-APCs) at intervals following treatment with CAR-T cells improves CD 19 CAR-T cell persistence and reduces the incidence of leukemia relapse.
Who can participate
Age range
1 Year – 30 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:
* Diagnosis of recurrent or refractory CD19+ leukemia
* Adequate performance status
* Able to tolerate apheresis, including placement of temporary apheresis line if required
* Adequate renal, liver, cardiac, and respiratory function
* Adequate absolute lymphocyte count
* HIV negative; Hepatitis B and C negative within 3 months prior to enrollment.
Exclusion Criteria:
* Evidence of active clinically significant CNS dysfunction
* Evidence of active malignancy other than CD19+ malignancy
* Evidence of active GVHD, or on immunosuppressive GVHD therapy within 4 weeks prior to enrollment
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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 CD19t T-APC product infusions will be assessed.
Timeframe: up to 6 months
2
Determine the feasibility of deriving and administering a CD19t T-APC product