Anti-CD22 Chimeric Receptor T Cells in Pediatric and Young Adults With Recurrent or Refractory CD… (NCT02315612) | Clinical Trial Compass
CompletedPhase 1
Anti-CD22 Chimeric Receptor T Cells in Pediatric and Young Adults With Recurrent or Refractory CD22-expressing B Cell Malignancies
United States134 participantsStarted 2014-12-12
Plain-language summary
Background:
\- One type of cancer therapy takes blood cells from a person, changes them in a lab, then gives the cells back to the person. In this study, researchers are using an anti-CD22 gene, a virus, and an immune receptor to change the cells.
Objective:
\- To see if giving anti-CD22 Chimeric Antigen Receptor (CAR) cells to young people with certain cancers is safe and effective.
Eligibility:
\- People ages 1-39 with a leukemia or lymphoma that has not been cured by standard therapy.
Design:
* Participants will be screened to ensure their cancer cells express the CD22 protein. They will also have medical history, physical exam, blood and urine tests, heart tests, scans, and x-rays. They may give spinal fluid or have bone marrow tests.
* Participants may have eye and neurologic exams.
* Participants will get a central venous catheter or a catheter in a large vein.
* Participants will have white blood cells removed. Blood is removed through a needle in an arm. White blood cells are removed. The rest of the blood is returned by needle in the other arm.
* The cells will be changed in a laboratory.
* Participants will get two IV chemotherapy drugs over 4 days. Some will stay in the hospital for this.
* All participants will be in the hospital to get anti-CD22 CAR cells through IV. They will stay until any bad side effects are gone.
* Participants will have many blood tests. They may repeat some screening exams.
* Participants will have monthly visits for 2-3 months, then every 3-6 months. They may repeat some screening exams.
* Participants will have follow-up for 15 years.
Who can participate
Age range
3 Years – 39 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
. Patient must have a B cell ALL (inclusive of ALL blast transformation from CML) or lymphoma and must have relapsed or refractory disease after at least one standard chemotherapy regimen and one salvage regimen. In view of the PI and the primary oncologist, there must be no available alternative curative therapies and subjects must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, recurred after SCT, or have disease activity that prohibits SCT at the time of enrollment.
. CD22 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 80% by flow cytometry. The choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each patent. In general, immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples and CSF when feasible.
. Patients must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis.
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
Toxicity
Timeframe: End of treatment
2
Response
Timeframe: 1 month, 3 months, and 6 months following CAR infusion
. Greater than or equal to 3 years of age (and at least 14.5 kg) and less than or equal to 39 years of age at time of enrollment.
Exclusion criteria
. Patients, parents/guardian(s), legally authorized representative (LAR), or durable power of attorney must be able to give consent and sign the informed consent document.
. Clinical performance status: Patients greater than or equal to 16 years of age: Karnofsky greater than or equal to 50%; Patients \< 16 years of age: Lansky scale greater than or equal to 50%. Subjects who are unable to walk because of paralysis, but who are upright in a wheelchair will be considered ambulatory for the purpose of calculating the performance score.
. Patients of child-bearing or child-fathering potential must be willing to practice birth control from the time of enrollment on this study and for 12 months after receiving the preparative regimen for women and for 4 months for the same for men.
. Patients must have adequate organ function as described below:
. Subjects with radiologically-detected active CNS lymphoma, leptomeningeal CNS disease or isolated CNS disease which are eligible for definitive CNS directed radiationtherapy will be excluded.
. Hyperleukocytosis (greater than or equal to 50,000 blasts/ L) or rapidly progressive disease that in the estimation of the investigator and sponsor would compromise ability to complete study therapy;