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CAR T-cell Therapy

Cell Therapies for Acute Myeloid Leukemia

Phase 1

Recruiting

Research Sponsored by Arcellx, Inc.

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

Study Summary

This trialwill assess a new form of therapy for AML and MDS, to determine its safety and effectiveness.

Who is the study for?

Adults with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS), who have tried certain treatments without success, can join. They must be in good general health with proper organ function and not pregnant. People are excluded if they've had recent heart issues, other active cancers needing treatment, severe infections, autoimmune diseases, or a history of certain blood clots.Check my eligibility

What is being tested?

The trial is testing ARC-T cells and SPRX002 to see if they're safe and effective for patients whose AML or MDS hasn't responded to previous treatments. It's an early-phase study which means it's one of the first times these therapies are being tested in humans.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system attacking normal cells while targeting cancer cells, infusion-related symptoms like fever or chills during treatment administration, and typical chemotherapy-associated effects such as fatigue, nausea, and increased risk of infection.

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

Incidence of treatment-emergent adverse events (TEAEs), including dose-limiting toxicities (DLTs) and establish recommended Phase II dose (RP2D)

Secondary outcome measures

Anti-Tumor Activity

Pharmacokinetics (PK)

Trial Design

1Treatment groups

Experimental Treatment

Group I: CD123-Specific Adapter (SPRX002) and Universal CAR-Modified T Cell (ARC-T Cells)Experimental Treatment2 Interventions

Arm 1: Phase 1 Study of monovalent CD123-Specific Adapter (SPRX002) and Universal CAR-Modified T cell (ARC-T Cells) for the Treatment of Patients with Relapsed or Refractory Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Arcellx, Inc.Lead Sponsor

2 Previous Clinical Trials

175 Total Patients Enrolled

Tim Welliver, MD, PhDStudy ChairArcellx, Inc.

1 Previous Clinical Trials

110 Total Patients Enrolled

Media Library

ARC-T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05457010 — Phase 1

Myelodysplastic Syndrome Research Study Groups: CD123-Specific Adapter (SPRX002) and Universal CAR-Modified T Cell (ARC-T Cells)

Myelodysplastic Syndrome Clinical Trial 2023: ARC-T Cells Highlights & Side Effects. Trial Name: NCT05457010 — Phase 1

ARC-T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05457010 — Phase 1

Frequently Asked Questions

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

How many clinical facilities have initiated this trial?

"At present, 5 clinical trial centres are recruiting patients. These sites exist in Baltimore, Duarte, New Rochelle and another five locations - it is encouraged to select a location as close to you as possible for convenience."

Answered by AI

What potential risks do CD123-Specific Adapter (SPRX002) and Universal CAR-Modified T Cell (ARC-T Cells) pose for patients?

"The safety of CD123-Specific Adapter (SPRX002) and Universal CAR-Modified T Cell (ARC-T Cells) is rated at 1 due to this being a Phase 1 trial, which implies that there are only preliminary data regarding both efficacy and safety."

Answered by AI

Is recruitment presently underway for this experiment?

"Affirmative. Data found on clinicaltrials.gov indicates that this medical trial, initially posted on November 28th 2022, is now actively seeking participants. A total of 24 persons are required for the trial to be conducted across 5 distinct sites."

Answered by AI

How many participants have signed up for this research endeavor?

"Affirmative. The clinicaltrials.gov database evidences that this medical research is actively seeking patients to partake in the study, which was originally posted on November 28th 2022 and recently updated on December 5th 2022. 24 individuals need to be enrolled from five distinct trial sites."

Answered by AI

What are the objectives behind this clinical experiment?

"The primary endpoint of the Arcellx, Inc. clinical trial which is running for a period of 24 months revolves around Adverse Events and Dose-Limiting Toxicities. The secondary endpoints this study seeks to measure include Pharmacokinetics (PK) in terms of Quantification of ARC-T cells and SPRX002 using vector copy number (VCN), Anti-tumor activity measured through International Working Group Response Criteria reviews regarding overall response rate, complete remission rate, negative minimum residual disease (MRD) results; as well as collection of blood samples in order to determine the drug concentration levels within subjects' bodies pertaining"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase I Study of Cell Therapies for the Treatment of Patients With Relapsed or Refractory AML or High-risk MDS

2022. "Phase I Study of Cell Therapies for the Treatment of Patients With Relapsed or Refractory AML or High-risk MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05457010.