← Back to Search

CAR T-cell Therapy

CS1-CAR T Therapy for Multiple Myeloma

Phase 1
Recruiting
Led By Myo Htut
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Karnofsky Performance Status (KPS) of >= 70%
Serum creatinine =< 2.5 x ULN or estimated creatinine clearance of >= 40 mL/min
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 15 years
Awards & highlights

Study Summary

This trial is testing a new immunotherapy treatment for relapsed or refractory multiple myeloma.

Who is the study for?
This trial is for patients with CS1 positive multiple myeloma that has relapsed or is refractory. Participants must have a good performance status, life expectancy of at least 16 weeks, and meet specific blood count and organ function criteria. They should not be on other treatments or have certain infections, autoimmune diseases, severe heart conditions, or CNS involvement by malignancy.Check my eligibility
What is being tested?
The trial tests the safety and optimal dose of CS1-CAR T therapy after chemotherapy in treating relapsed/refractory multiple myeloma. It involves modifying immune cells to recognize and kill cancer cells using a lentiviral vector called CS1.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune cell infusion such as fever and fatigue, complications from low blood counts like bleeding or infection risks, liver enzyme elevations indicating liver stress, and possible damage to organs targeted by the engineered immune cells.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am able to care for myself but may not be able to do active work.
Select...
My kidney function is within the required range.
Select...
I agree to use birth control or abstain from sex if I can father a child.
Select...
My condition did not improve after 3 different treatments.
Select...
I have been diagnosed with active multiple myeloma.
Select...
My heart pumps well, with an ejection fraction of 45% or higher.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 15 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 15 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of all other toxicities
Incidence of dose-limiting toxicity (DLT) and all other toxicities
Opportunistic infections
+1 more
Secondary outcome measures
CS1 expression on multiple myeloma cells
Cytokine and soluble CS-1 levels in blood and marrow
Disease free survival (DFS)
+4 more
Other outcome measures
MM cells that are CS-1 positive

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (leukapheresis, chemotherapy, CS-1 CAR T therapy)Experimental Treatment4 Interventions
Patients undergo leukapheresis over 2-4 hours. Beginning 3-4 weeks, patients receive cyclophosphamide IV on days -4 and/or -3 or fludarabine IV and cyclophosphamide IV on days -5 to -3. Patients then undergo CS1-CAR T therapy over 10-15 minutes on day 0.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
1995
Completed Phase 3
~3780
Leukapheresis
2010
Completed Phase 2
~640
Fludarabine
2012
Completed Phase 3
~1100

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor
561 Previous Clinical Trials
1,918,222 Total Patients Enrolled
37 Trials studying Multiple Myeloma
3,429 Patients Enrolled for Multiple Myeloma
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,365 Total Patients Enrolled
573 Trials studying Multiple Myeloma
188,003 Patients Enrolled for Multiple Myeloma
Myo HtutPrincipal InvestigatorCity of Hope Medical Center

Media Library

CS1-CAR T Therapy (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03710421 — Phase 1
Multiple Myeloma Research Study Groups: Treatment (leukapheresis, chemotherapy, CS-1 CAR T therapy)
Multiple Myeloma Clinical Trial 2023: CS1-CAR T Therapy Highlights & Side Effects. Trial Name: NCT03710421 — Phase 1
CS1-CAR T Therapy (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03710421 — Phase 1

Frequently Asked Questions

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

Is this research presently open to enrollment?

"According to clinicaltrials.gov, this study is presently accepting applications from prospective participants. The trial was first established on February 13th 2019 and has been refreshed as of November 22nd 2022."

Answered by AI

Could you please inform me of any past experiments conducted with regard to CS1-CAR T Therapy?

"Currently, 889 clinical trials are investigating the efficacy of CS1-CAR T Therapy. Of these studies, 161 are in Phase 3 and 28443 locations across the country have active research sites for this treatment. Notably, a significant amount of data is being gathered from Philadelphia, Pennsylvania."

Answered by AI

Is CS1-CAR T Therapy a hazardous treatment for patients?

"Based on our assessment, CS1-CAR T Therapy has a rating of 1 due to the fact that we are currently conducting Phase 1 trials with limited data regarding its efficacy and safety."

Answered by AI

What is the common purpose of CS1-CAR T Therapy treatments?

"CS1-CAR T Therapy is often prescribed to those suffering from multiple sclerosis; however, it can also be effective at treating various other cancers such as mixed-cell type lymphoma, leukemia, myelocytic acute and retinoblastoma."

Answered by AI

How many participants are currently taking part in this clinical trial?

"Affirmative, the information on clinicaltrials.gov verifies that this trial is currently recruiting participants. This medical study was initially posted in February 13th 2019 and recently revised on November 22nd 2022 with a target of 30 patients at one site."

Answered by AI
~4 spots leftby Feb 2025