← Back to Search

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

Must not have

AEs from previous treatment that have not recovered

Patients have received steroids before leukapheresis or lymphodepletion

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 - month 60

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I am fully active or can carry out light work.

Select...

I am between 18 and 79 years old.

Select...

My last cancer treatment did not work.

Select...

I have been treated with specific cancer drugs including a proteasome inhibitor, an IMiD, and a CD38 antibody.

Select...

I can undergo leukapheresis without any medical issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I still have side effects from past treatments that haven't gone away.

Select...

I have taken steroids before my cell collection or before reducing my white blood cells.

Select...

My cancer has spread to my brain.

Select...

I have a serious lung condition.

Select...

I have graft versus host disease.

Select...

I have an active autoimmune disease like psoriasis or rheumatoid arthritis.

Select...

I have a specific blood disorder with signs of organ damage.

Select...

I have undergone cancer treatment before leukapheresis.

Select...

I do not have active HIV, hepatitis B, or hepatitis C.

Select...

I do not have any ongoing infections that aren't being treated.

Select...

I have had major surgery before my leukapheresis or lymphodepletion.

Select...

I received a live vaccine before my cell collection or before my immune cells were reduced.

Select...

I do not have any cancer other than multiple myeloma.

Select...

I am not allergic to Flu, Cy, tocilizumab, DMSO, or zevor-cel CAR BCMA T cell treatments.

Select...

I have received anti-BCMA therapy.

Select...

I had a stem cell transplant more than a year ago.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 - month 60

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Identification of Maximum Tolerated Dose (MTD)

Incidence of Treatment Related adverse events (AEs)

Objective response rate

Secondary study objectives

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 study objectives

BCMA bone marrow expression and soluble BCMA expression in blood

Cytokine profiling

zevor-cel product profiling vs clinical safety and efficacy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 21Eligibility criteria met