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CAR-T Cell Therapy for Lymphoma
Study Summary
This trial is testing a new immunotherapy to see if it can treat relapsed or difficult-to-treat lymphoid cancers.
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?
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- It has been at least 28 days since I last received experimental treatment.I had a stem cell transplant 3 months ago and am not on immunosuppressants.I can take care of myself and am up and about more than half of my waking hours.I am HIV positive.I do not have any uncontrolled illnesses that would affect my participation.I am experiencing symptoms of graft versus host disease.My cancer is CD19 positive.I agree to use effective birth control or remain abstinent during and after treatment.I agree to use effective birth control or remain abstinent and not donate sperm during and for 6 months after treatment.I have an autoimmune disease and have taken immunosuppressants in the last 6 months.I have hepatitis but my PCR test for it is negative.I have a significant brain-related condition like epilepsy, stroke, or Parkinson's.I do not have active brain involvement by cancer.I can understand and am willing to sign the consent form.My oxygen level is 92% or higher without extra oxygen.My lymphoma or leukemia has not improved after at least two treatments.I had a stem cell transplant using my own cells less than 6 weeks ago.My heart pumps well, with an ejection fraction of 40% or higher.I do not have another active cancer except for non-dangerous skin cancer or very early stage cancers.My tests show early signs of a bone marrow disorder before starting treatment.My brain or spinal cord cancer has been in remission for at least 90 days.I am not pregnant or breastfeeding and have a negative pregnancy test.
- Group 1: Group A - NHL/CLL
- Group 2: Group B - ALL
- 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
Has the Fully Human anti CD19 CAR-T Cell Dose obtained clearance from the relevant regulatory body?
"As this is a phase 1 trial, where safety and efficacy of the Fully human anti CD19 CAR-T Cell Dose are both unknown, we can only give it an estimated score of 1 on our rating scale."
How many participants are sought for this experiment?
"Affirmative, according to the information on clinicaltrials.gov this investigation is actively seeking participants. It was initially advertised on April 26th 2021 and has since been updated October 4th 2022. The trial necessitates 36 volunteers from a single medical centre."
Is there any published research detailing the effects of administering a Fully human anti CD19 CAR-T Cell Dose?
"At the present moment, there are 889 live trials studying Fully human anti CD19 CAR-T Cell Dose; of which 161 have reached Phase 3. Though most studies are located in Philadelphia, Pennsylvania, 28444 sites around the world offer this medication to participants."
Are there still vacancies for participants in this research endeavor?
"Yes, the clinicaltrials.gov portal indicates that this research is still looking for participants. It was initially published on April 26th 2021 and most recently updated on October 4th 2022; 36 volunteers from one medical site are required to take part in this trial."
What health conditions can be addressed by using a typical dosage of Fully human anti CD19 CAR-T Cells?
"Fully human anti CD19 CAR-T Cell Dose has been observed to have a positive impact on multiple sclerosis, various forms of leukemia, and mixed-cell type lymphoma."
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