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Zevor-cel for Multiple Myeloma
Study Summary
This trial is testing a new treatment for multiple myeloma that uses the patient's own immune cells.
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 fully active or can carry out light work.I am unable or unwilling to follow the clinical trial requirements.I still have side effects from past treatments that haven't gone away.My blood, kidney, and liver tests are within normal ranges.Patients must have a disease that can be measured according to specific guidelines.I have taken steroids before my cell collection or before reducing my white blood cells.My cancer has spread to my brain.I have a serious lung condition.I have graft versus host disease.You are expected to live for at least 3 months.I have an active autoimmune disease like psoriasis or rheumatoid arthritis.I have a specific blood disorder with signs of organ damage.I am between 18 and 79 years old.I have undergone cancer treatment before leukapheresis.My last cancer treatment did not work.I do not have active HIV, hepatitis B, or hepatitis C.I do not have any ongoing infections that aren't being treated.I have received multiple treatments for myeloma.I have been treated with specific cancer drugs including a proteasome inhibitor, an IMiD, and a CD38 antibody.You have major neurological disorders.I can undergo leukapheresis without any medical issues.I have had major surgery before my leukapheresis or lymphodepletion.I received a live vaccine before my cell collection or before my immune cells were reduced.I am a man and willing to use contraception for at least 12 months after T cell infusion.I do not have any cancer other than multiple myeloma.I am not allergic to Flu, Cy, tocilizumab, DMSO, or zevor-cel CAR BCMA T cell treatments.I have received anti-BCMA therapy.I had a stem cell transplant more than a year ago.I have serious heart conditions that could make this trial unsafe for me.
- Group 1: CAR-BCMA 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
Are enrollment opportunities available for this experiment currently?
"Affirmative, the clinical trial is actively recruiting individuals. It was initially posted on September 25th 2019 and recently modified on July 18th 2022 according to data hosted by clinicaltrials.gov."
To what extent has enrollment increased in this clinical trial?
"Affirmative. The details hosted on clinicaltrials.gov suggest that this medical investigation, initially posted in September 2019, is actively seeking participants. In total 105 individuals need to be recruited from 14 different locations."
How many healthcare facilities are currently conducting this experiment?
"Currently, 14 sites are recruiting volunteers for this trial. These locations span across Denver, Nashville and Milwaukee in addition to 11 other cities; it is thus recommended that you select the site nearest your residence so as to reduce commuting requirements."
Is there an eligibility criteria for individuals wishing to engage in this medical research?
"This medical trial is attempting to recruit 105 people aged 18-79 who have been diagnosed with multiple myeloma. The following prerequisites must be met: written consent, prior treatment involving a proteasome inhibitor and an IMiD/CD38 antibody, refractory nature of the last line of therapy, tangible symptoms in accordance with International Myeloma Working Group criteria, life expectancy exceeding 12 weeks, Eastern Cooperative Oncology Group (ECOG) performance score 0-1 and reasonable blood cell counts, functioning renal system and liver as well as appropriate venous access for leukapheresis collection. Additionally there can be no"
What is the overall objective of this experimental research?
"Carsgen Therapeutics, Ltd., the sponsoring organisation of this study, reported that its primary goal - to be measured over a 60-day period - is to identify Maximum Tolerated Dose (MTD). Additionally, they will assess secondary objectives such as determining zevor-cel's efficacy in rrMM patients through Investigator Assessment parameters like ORR and DOR; Disease Response Criteria including Complete Response (CR), MRD etc.; Time to Progression/Response; Progression Free Survival; Best Response and Overall Survival. Last but not least, HRQoL change from baseline up until completion of the trial will"
Does this clinical experiment accept participants aged 60 or older?
"The entry requirements for this clinical trial stipulate that applicants must be between the ages of 18-79. Meanwhile, 40 studies are allocated to those under 18 and 793 investigations have been assigned to seniors over 65 years old."
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