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CAR T-cell Therapy

ATLCAR.CD138 T Cells for Multiple Myeloma

Phase 1

Recruiting

Led By Sascha Tuchman, MD, MHS

Research Sponsored by UNC Lineberger Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Received at least 3 lines of prior chemotherapy

Received high dose melphalan followed by autologous stem-cell transplant (ASCT) or is not eligible for or has declined the procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 15 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying whether adding the anti-CD138 antibody to T cells can improve the T cells' ability to kill cancer cells and whether it can help to control the cancer.

Who is the study for?

This trial is for adults over 18 with relapsed or refractory multiple myeloma, who've had at least three prior chemotherapy treatments and are not eligible for or have declined a stem-cell transplant. Participants need to be in stable condition without infections, serious heart issues, or other cancers. They must agree to use contraception if necessary and comply with study procedures.

What is being tested?

The trial is testing CAR138 T cells, which are the patient's own immune cells modified to target cancer cells more effectively. These special T cells carry a part of an antibody that recognizes and attaches to multiple myeloma cells, potentially enhancing the body's ability to fight this type of cancer.

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal tissues (autoimmunity), symptoms from infusion such as fever or chills, fatigue, increased risk of infection due to weakened immunity, and possible organ inflammation.

Eligibility Criteria

Inclusion Criteria

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

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I have undergone 3 or more chemotherapy treatments.

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I have either undergone a stem-cell transplant after high dose melphalan or am not eligible for/have declined it.

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I am using two birth control methods, am surgically sterile, or not having heterosexual sex.

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I had CAR-T therapy over 9 months ago and have no better treatment options.

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I have not been diagnosed with the specified conditions.

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I do not have an active stomach or bowel infection or inflammation.

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My CAR T-cell therapy meets the required quality standards.

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My organs are functioning well enough for treatment.

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I am a man who either had a vasectomy or will use contraception.

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My tumor is not located where it could block my airway if it grows.

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I do not have any current infections.

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I am not currently taking high doses of steroids.

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I haven't taken experimental drugs or cancer vaccines in the weeks before my treatment.

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I don't have any brain or nerve diseases that could affect monitoring after CAR-T therapy.

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My multiple myeloma has returned or is not responding to treatment.

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I stopped radiation therapy at least a week ago.

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I am able to care for myself but may need occasional help.

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I stopped my chemotherapy at least 14 days before starting lymphodepletion.

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I do not have any current infections.

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I do not have any mental or brain conditions that would stop me from participating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 15 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~15 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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

Proportion of participants with dose limiting toxicities as a measure of maximum tolerated dose of CAR138 T cells

Secondary study objectives

Heart rate

Overall survival after infusion of CAR138 T cells

Progression free survival after infusion of CAR138 T cells

+1 more

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: CAR138 T cellsExperimental Treatment1 Intervention

The first 3 subjects enrolled in the study will receive 5x10\^6 CAR138 T-cells/m\^2 via infusion. The number of cells for the infusion will be increased to 1x10\^7 CAR138 T-cells/m\^2 and then, 2.5x10\^7 CAR138 T-cells/m\^2, 5x10\^7 CAR138 T-cells/m\^2, 1x10\^8 CAR138 T-cells/m\^2 and 2x10\^8 CAR138 T-cells/m\^2 in subsequent cohorts of 3 subjects provided no dose limiting toxicities (DLTs) are observed within 4 weeks of the cell infusion. Cohort enrollment will be staggered, requiring each subject to complete at least 2 weeks of safety monitoring following CAR138 T-cell infusion at the designated dose level for the cohort before another subject is allowed to enroll in the cohort.

0 / 20Eligibility criteria met