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CAR T-cell Therapy

Zevor-cel for Multiple Myeloma

Phase 1 & 2
Waitlist Available
Led By Shaji Kumar, MD
Research Sponsored by Carsgen Therapeutics, Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance score 0-1
Age of ≥ 18 and < 80 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 - month 60
Awards & highlights

Study Summary

This trial is testing a new treatment for multiple myeloma that uses the patient's own immune cells.

Who is the study for?
This trial is for adults aged 18-79 with relapsed/refractory multiple myeloma who've had specific prior treatments and are not responding to their last therapy. They must have good organ function, no recent major surgery or cancer treatments, no active infections like HIV/HBV/HCV, and agree to use contraception for a year post-treatment.Check my eligibility
What is being tested?
The study tests Zevor-cel (CT053), a CAR T-cell therapy targeting BCMA in patients whose multiple myeloma has returned or resisted treatment. It's an early-stage trial assessing the safety and effectiveness of this new intervention.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, infusion-related responses, changes in blood counts, fatigue, risk of infection due to weakened immunity, allergic reactions to components of the treatment regimen.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or can carry out light work.
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I am between 18 and 79 years old.
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My last cancer treatment did not work.
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I have been treated with specific cancer drugs including a proteasome inhibitor, an IMiD, and a CD38 antibody.
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I can undergo leukapheresis without any medical issues.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 - month 60
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 - month 60 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Identification of Maximum Tolerated Dose (MTD)
Incidence of Treatment Related adverse events (AEs)
Objective response rate
Secondary outcome measures
Determine the efficacy of zevor-cel treatment in patients with rrMM, by investigator assessment
Evaluate ADA profile
Evaluate HRQoL in patients with rrMM from baseline up to study completion
+3 more
Other outcome measures
BCMA bone marrow expression and soluble BCMA expression in blood
Cytokine profiling
zevor-cel product profiling vs clinical safety and efficacy

Trial Design

1Treatment groups
Experimental Treatment
Group I: CAR-BCMA T CellsExperimental Treatment1 Intervention
Phase 1b will include a dose escalation followed by an expansion cohort to determine the recommended dose for the expansion part. After recommended Phase 2 is determined, patients in Phase 2 will be treated.

Find a Location

Who is running the clinical trial?

Carsgen Therapeutics, Ltd.Lead Sponsor
7 Previous Clinical Trials
534 Total Patients Enrolled
1 Trials studying Multiple Myeloma
121 Patients Enrolled for Multiple Myeloma
CARsgen Therapeutics Co., Ltd.Lead Sponsor
24 Previous Clinical Trials
1,019 Total Patients Enrolled
8 Trials studying Multiple Myeloma
364 Patients Enrolled for Multiple Myeloma
Shaji Kumar, MDPrincipal InvestigatorMayo
1 Previous Clinical Trials
87 Total Patients Enrolled
1 Trials studying Multiple Myeloma
87 Patients Enrolled for Multiple Myeloma

Media Library

Zevor-cel (CT053) (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03915184 — Phase 1 & 2
Multiple Myeloma Research Study Groups: CAR-BCMA T Cells
Multiple Myeloma Clinical Trial 2023: Zevor-cel (CT053) Highlights & Side Effects. Trial Name: NCT03915184 — Phase 1 & 2
Zevor-cel (CT053) (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03915184 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

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"

Answered by AI

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"

Answered by AI

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."

Answered by AI
~13 spots leftby Dec 2024