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CAR T-Cell Therapy for Leukemia
Study Summary
This trial is testing a new cancer treatment involving genetically-engineered immune cells and chemotherapy. The goal is to see if the treatment is effective and has manageable side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- I have a history of certain infections.I have received a CD19/CD22 CAR-T cell therapy infusion.My cancer returned to the brain after complete remission, and I have MRD confirmed twice.I had CAR T-cell therapy over 30 days ago and no signs of those cells remain in my blood.I am not pregnant and cannot become pregnant due to surgery or being postmenopausal for 2+ years.I have been cancer-free from another type of cancer for at least 3 years, or my doctor thinks I'm a good candidate despite being in remission for 1-2 years.I am HIV positive.I do not have any brain-related health issues that could affect the study.I haven't had a heart attack or other major heart issues in the last year.My leukemia is a type of B-cell ALL that has come back or didn't respond to treatment.My cancer can be measured or seen on tests, even if previously treated with radiation.I have fully recovered from any side effects of previous spinal chemotherapy.I am on maintenance chemo for ALL but can stop it 1 week or 5 half-lives before apheresis.I am on a low dose of steroids (≤5 mg/day of prednisone or equivalent) and haven't increased the dose in the last 2 weeks.I finished radiation therapy 3 weeks ago, or it treated less than 10% of my bone marrow.I can take care of myself but may not be able to do heavy physical work.My kidney, liver, lung, and heart functions are all within normal ranges.My kidney function is normal or only slightly impaired.My brain involvement does not affect my ability to be assessed for treatment side effects.I haven't had a fever or severe side effects in the last 12 hours.I have been in remission for over a year and am on hormonal therapy.My leukemia has worsened despite taking a TKI medication.My B-ALL cancer did not respond to my first chemotherapy treatment.My cancer has come back after it was completely gone.My cancer has come back or remains, confirmed twice at least 4 weeks apart.I had a stem cell transplant and my disease got worse after, or I had one without signs of GVHD and haven't taken immunosuppressants for 30 days.Side effects from my previous treatments are mild or gone, except for hair loss.I am 18 years old or older.I haven't had severe immune reactions within 4 days before my treatment.I do not have ongoing severe nerve damage.My cancer has shown CD19 positive at some point since diagnosis.I haven't taken tocilizumab or dexamethasone in the last 48 hours.My heart pumps well and I don't have significant fluid around it.My organs and bone marrow are functioning normally.I do not have any serious infections, or if I do, they are under control.I have had skin cancer or early-stage cancer in specific areas but am still eligible.I do not have any serious or uncontrolled infections.It's been over 2 weeks or 5 half-lives since my last systemic therapy, except for immune therapy.I have had hepatitis B or C, but my viral load is now undetectable.I have never had severe nerve damage symptoms for more than 48 hours before.
- Group 1: Treatment (CD19/CD22 CAR T cells, chemotherapy, NKTR-255)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any vacancies for participants in this study?
"Data sourced from clinicaltrials.gov reveals that this research trial is actively seeking participants, having been initially posted on September 1st 2017 and last modified on May 14th 20202."
What medical indications does Fludarabine Phosphate address?
"Fludarabine Phosphate is widely used to manage cases of multiple sclerosis, as well as a range of other medical conditions including lymphoma, leukemia, myelocytic acute and retinoblastoma."
What is the aggregate size of this trial's participant group?
"Affirmative. The clinicaltrials.gov portal reveals that this medical trial, which was originally posted on September 1st 2017, is actively recruiting patients for participation. 60 individuals are needed from one site location to complete the study's requirements."
What other research initiatives have there been using Fludarabine Phosphate as a focal point?
"Currently, 889 medical research initiatives are being conducted in regards to Fludarabine Phosphate. Of those studies, 161 have advanced to the 3rd phase of clinical trials; these primarily take place in Philadelphia, PA with 28443 other sites across the US also running experiments."
Can Fludarabine Phosphate be legally administered in the US?
"Careful examination of the available data leads to a score of 1 for fludarabine phosphate, as Phase 1 trials provide limited evidence regarding safety and efficacy."
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