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ATLCAR.CD138 T Cells for Multiple Myeloma
Study Summary
This trial is studying whether adding the anti-CD138 antibody to T cells can improve the T cells' ability to kill cancer cells and whether it can help to control the cancer.
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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- I am 18 years old or older.I have undergone 3 or more chemotherapy treatments.I have either undergone a stem-cell transplant after high dose melphalan or am not eligible for/have declined it.I have had a stem cell transplant from a donor under certain conditions.I am using two birth control methods, am surgically sterile, or not having heterosexual sex.I had CAR-T therapy over 9 months ago and have no better treatment options.I have not been diagnosed with the specified conditions.I do not have an active stomach or bowel infection or inflammation.I have no other cancers except for certain allowed types.My CAR T-cell therapy meets the required quality standards.I stopped taking corticosteroids 2 days before starting chemotherapy to weaken my immune system.My organs are functioning well enough for treatment.I have not had major surgery in the last 4 weeks.I am a man who either had a vasectomy or will use contraception.My tumor is not located where it could block my airway if it grows.I do not have any current infections.My organs are functioning well.I am not currently taking high doses of steroids.My heart is functioning well.I haven't taken experimental drugs or cancer vaccines in the weeks before my treatment.I don't have any brain or nerve diseases that could affect monitoring after CAR-T therapy.I am considered a good candidate for CAR138 T-cell therapy.My multiple myeloma has returned or is not responding to treatment.You need to have had multiple myeloma blood tests done within 7 days before the treatment that weakens the immune system.I stopped radiation therapy at least a week ago.I am able to care for myself but may need occasional help.I stopped my chemotherapy at least 14 days before starting lymphodepletion.I do not have any current infections.My organs are functioning well.I have no other cancers except for certain allowed types.I have signed the consent form for the CAR T-cell therapy trial before starting lymphodepletion.I do not have any mental or brain conditions that would stop me from participating.You have a disease that can be measured using certain criteria.
- Group 1: CAR138 T cells
- 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
What is the sample size for this clinical research?
"Affirmative. Per information hosted on clinicaltrials.gov, this medical study is still recruiting patients since it was first published in the 14th of January 2019 and most recently updated at the 28th of July 2022. 33 participants are needed for this research conducted across a single site."
Has the Food and Drug Administration sanctioned CAR138 T Cells?
"Our internal assessment at Power gave CAR138 T Cells a score of 1, as this Phase 1 trial has only produced scant evidence supporting safety and efficacy."
Is this investigation actively seeking participants?
"Affirmative. Clinicaltrials.gov provides evidence that this medical trial is actively looking for participants; the study was initially posted on 14th January 2019 and most recently updated on 28th July 2022. 33 individuals need to be recruited from a single site."
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