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CAR T-cell Therapy

Cell Therapy for Multiple Myeloma

Phase 1

Recruiting

Research Sponsored by Kite, A Gilead Company

Eligibility Criteria Checklist

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

Must have

Relapsed and refractory Multiple Myeloma treated with at least 3 prior regimens of system therapy including Proteosome Inhibitor (PI), immunomodulatory drugs (IMiD), and anti-CD38 antibody (CD38mab); or has 'triple-refractory' disease

Life expectancy > 12 weeks, Eastern Cooperative Group Performance Status 0-1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trial is testing a new cell therapy for cancer, and includes follow-up to see how safe it is.

Who is the study for?

This trial is for people with multiple myeloma who have tried at least three treatments, including proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies. They should not be severely ill with other conditions or have a history of plasma cell leukemia. Participants need to be relatively healthy otherwise and expected to live more than 12 weeks.Check my eligibility

What is being tested?

The study is testing new cell therapies called ARC-T Plus Anti-BCMA SparX and CART-ddBCMA in patients whose multiple myeloma has come back or hasn't responded after several treatments. It's an early-stage trial to see if these therapies are safe and how they work.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal cells by mistake, infusion-related symptoms like fever or chills, fatigue, nausea, as well as risks associated with bone marrow suppression such as infections.

Eligibility Criteria

Inclusion Criteria

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

Select...

My multiple myeloma has not responded to 3 types of treatments including PI, IMiD, and CD38mab.

Select...

My doctor expects me to live more than 12 weeks and I can do most of my daily activities.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Establish the RP2D of the investigational agent

Incidence of treatment-emergent adverse events (TEAEs), including DLT(s)

Secondary outcome measures

Best overall response (BOR) by IMWG Consensus Criteria

In vivo pharmacokinetics

ORR by IMWG Consensus Criteria

Trial Design

1Treatment groups

Experimental Treatment

Group I: ARM 1Experimental Treatment2 Interventions

Phase I study of BCMA-specific CAR-modified T-cell therapy using alternative binding domain, for the treatment of patients with relapsed and refractory multiple myeloma

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Arcellx, Inc.Industry Sponsor

3 Previous Clinical Trials

584 Total Patients Enrolled

2 Trials studying Multiple Myeloma

560 Patients Enrolled for Multiple Myeloma

Kite, A Gilead CompanyLead Sponsor

44 Previous Clinical Trials

4,036 Total Patients Enrolled

4 Trials studying Multiple Myeloma

593 Patients Enrolled for Multiple Myeloma

Media Library

ARC-T Plus Anti-BCMA SparX (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04155749 — Phase 1

Multiple Myeloma Research Study Groups: ARM 1

Multiple Myeloma Clinical Trial 2023: ARC-T Plus Anti-BCMA SparX Highlights & Side Effects. Trial Name: NCT04155749 — Phase 1

ARC-T Plus Anti-BCMA SparX (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04155749 — Phase 1

Frequently Asked Questions

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

Are there any vacant slots for participants in this clinical trial?

"According to the information provided on clinicaltrials.gov, this research is actively seeking participants. The trial was first published on November 18th of 2019 and has been updated recently as of July 29th 2022."

Answered by AI

Is CART-ddBCMA a safe and viable treatment option for patients?

"As this is the initial clinical trial for CART-ddBCMA, there is limited evidence of safety or efficacy. Thus our team at Power has assigned it a score of 1 on their risk scale."

Answered by AI

How many participants are being accepted for this research project?

"Arcellx, Inc., the sponsor of this trial, is recruiting 65 eligible patients from multiple locations across America including University of Chicago Medicine Comprehensive Cancer Center and Massachusetts General Hospital."

Answered by AI

Recent research and studies

Molecular Cancer TherapeuticsJournal

Preclinical Efficacy of Bcma-directed CAR T Cells Incorporating a Novel D Domain Antigen Recognition Domain

Buonato, Janine M., Justin P. Edwards, Liubov Zaritskaya, Alexandra R. Witter, Ankit Gupta, David W. LaFleur, David A. Tice, Laura K. Richman, and David M. Hilbert. 2022. “Preclinical Efficacy of Bcma-directed CAR T Cells Incorporating a Novel D Domain Antigen Recognition Domain”. Molecular Cancer Therapeutics. American Association for Cancer Research (AACR). doi:10.1158/1535-7163.mct-21-0552.

Molecular Cancer TherapeuticsJournal

Preclinical Efficacy of Bcma-directed CAR T Cells Incorporating a Novel D Domain Antigen Recognition Domain

clinicaltrials.govStudy

Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma

2019. "Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04155749.