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CAR T-cell Therapy

CAR-T Therapy for Multiple Myeloma

Saint Louis, MO

Phase 1

Recruiting

Led By Armin Ghobadi, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Relapsed or refractory multiple myeloma after 3 or more prior lines of therapy, including specific medications

At least 18 years of age

Must not have

History of CS1-directed therapies

Ongoing or active infection or other serious underlying medical condition that would impair the ability to receive protocol treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from ws-cart-cs1 infusion through completion of follow-up (estimated to be 15 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new therapy for multiple myeloma, a type of cancer that currently has no cure. The therapy targets a protein called CS1, which is found in most patients with multiple

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Who is the study for?

This trial is for individuals with multiple myeloma, a type of blood cancer. Participants should have tried other treatments that didn't work well enough. They must be healthy enough to undergo the procedure and not have any infections or immune system problems that could make it unsafe.Check my eligibility

What is being tested?

The trial is testing WS-CART-CS1, a new CAR-T cell therapy targeting CS1 on cancer cells, combined with lymphodepleting chemotherapy which prepares the body for the CAR-T treatment by lowering immune cells.See study design

What are the potential side effects?

CAR-T therapies like WS-CART-CS1 can cause cytokine release syndrome (flu-like symptoms, fever), neurologic effects (confusion or difficulty speaking), low blood cell counts, infection risk increase, and potential allergic reactions to treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My multiple myeloma has returned or didn't respond after 3 treatments.

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I am 18 years old or older.

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I am fully active and can carry on all my pre-disease activities without restriction.

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Exclusion Criteria

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

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I have been treated with CS1-targeted therapies before.

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I do not have any infections or serious conditions that would stop me from receiving treatment.

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

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I haven't had any cell therapy in the last 8 weeks.

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I have had severe reactions to previous CAR-T cell therapies.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from ws-cart-cs1 infusion through completion of follow-up (estimated to be 15 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from ws-cart-cs1 infusion through completion of follow-up (estimated to be 15 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from ws-cart-cs1 infusion through completion of follow-up (estimated to be 15 years) for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Part A: Frequency and severity of treatment-emergent adverse events

Part A: Frequency of dose-limiting toxicities (DLTs)

Part B: Frequency and severity of treatment-emergent adverse events

Secondary study objectives

Part A MTD and Part B: Disease-specific objective response rate (ORR)

Part A MTD and Part B: Duration of response (DoR)

Part A MTD and Part B: Minimal residual disease (MRD) negativity in the marrow

+2 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Part B Dose Expansion: WS-CART-CS1Experimental Treatment2 Interventions

* Undergo apheresis procedure for WS-CART-CS1 manufacturing. * Anti-multiple myeloma therapy may be given after leukapheresis and up to one week prior to the start of lymphodepleting chemotherapy at the discretion of the treating physician. * Lymphodepleting chemotherapy on days -5, -4, and -3. * Three days following the last dose of lymphodepleting chemotherapy (on Day 0), WS-CART-CS1 will be infused. * Part B is the dose expansion portion of the study. The dose of WS-CART-CS1 will be determined in Part A of the study.

Group II: Part A Dose Escalation: WS-CART-CS1Experimental Treatment2 Interventions

* Undergo apheresis procedure for WS-CART-CS1 manufacturing. * Anti-multiple myeloma therapy may be given after leukapheresis and up to one week prior to the start of lymphodepleting chemotherapy at the discretion of the treating physician. * Lymphodepleting chemotherapy on days -5, -4, and -3. * Three days following the last dose of lymphodepleting chemotherapy (on Day 0), WS-CART-CS1 will be infused. * Part A is the dose escalation portion of the study with the starting dose of 0.5 x 10\^6 cells/kg of WS-CART-CS1.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lymphodepleting chemotherapy

2014

Completed Phase 2

~130

0 / 8Eligibility criteria met