← Back to Search

CAR T-cell Therapy

UCART123v1.2 for Acute Myeloid Leukemia (AMELI-01 Trial)

Phase 1

Recruiting

Led By Gail Roboz, Dr

Research Sponsored by Cellectis S.A.

Eligibility Criteria Checklist

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

Must have

Patients with CD123+ blast cells (verified by flow cytometry)

Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of ≤1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

AMELI-01 Trial Summary

This trial is testing a new treatment for leukemia that targets the CD123 protein. The purpose is to find the maximum tolerated dose and to see if it is effective.

Who is the study for?

This trial is for adults with relapsed or primary refractory Acute Myeloid Leukemia (AML) who have more than 5% bone marrow blasts and CD123+ blast cells. Participants must be in good physical condition with an ECOG-PS of ≤1 and proper organ function. For the dose-escalation part, a donor and transplant strategy must be identified before starting treatment.Check my eligibility

What is being tested?

The study tests UCART123v1.2, a Universal Chimeric Antigen Receptor T-cell therapy targeting CD123 in AML patients. It's an early-phase trial to find out how safe it is, its effectiveness, and the best dosage levels.See study design

What are the potential side effects?

Potential side effects may include immune system reactions, infusion-related responses, impact on blood counts leading to increased infection risk or bleeding problems, fatigue, fever, and potential harm to organs like liver or kidneys.

AMELI-01 Trial Eligibility Criteria

Inclusion Criteria

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

Select...

My leukemia cells test positive for CD123.

Select...

I can carry out all my self-care but cannot do heavy physical work.

Select...

My AML has returned or didn't respond to treatment, with more than 5% of my bone marrow cells being cancerous.

Select...

My organs, including my bone marrow, kidneys, liver, lungs, and heart, are functioning well.

Select...

My AML has returned or didn't respond to treatment, with more than 5% of my bone marrow cells being blasts.

AMELI-01 Trial 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

Dose escalation and expansion part: Occurrence of DLTs

Incidence of adverse events (AE)/serious adverse events (SAE)/Dose Limiting Toxicities (DLT) [Safety and Tolerability]

Secondary outcome measures

Duration of Response

Investigators assessed overall response rate according to the European Leukemia Net (ELN) Response Criteria

Overall Survival

+13 more

AMELI-01 Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose EscalationExperimental Treatment1 Intervention

UCART123v1.2 tested at several dose levels with different lymphodepletion regimens to establish Maximum Tolerated Dose (MTD) and identify Recommended Phase 2 Dose (RP2D) Dose Expansion: UCART123v1.2 administered at the RP2D determined from the dose escalation phase

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cellectis S.A.Lead Sponsor

5 Previous Clinical Trials

132 Total Patients Enrolled

Gail Roboz, DrPrincipal InvestigatorWeill Medical College of Cornell University

Frequently Asked Questions

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

Is it widespread for medical centers in Canada to host this clinical experiment?

"At present, 9 medical sites are recruiting individuals for this trial. These locations span from San Francisco to Buffalo and New york; selecting the closest centre is recommended in order to reduce any travel burden that could arise due to participation."

Answered by AI

Is enrollment in this research endeavor open to the public?

"To be eligible to join this medical trial, prospective participants must have acute myelocytic leukemia and range in age from 18-65 years. 65 total patients are being recruited for the study."

Answered by AI

Are there any opportunities for prospective participants to join this research endeavor?

"According to the records on clinicaltrials.gov, this experiment is currently in search of participants. It was originally posted on June 19th 2017 and most recently updated on 6/6/2022."

Answered by AI

Has the FDA sanctioned the use of UCART123v1.2?

"Given the limited information available, our professionals at Power have cautiously assigned UCART123v1.2 a score of 1 on safety due to its Phase 1 status."

Answered by AI

How many participants have joined this research project?

"Affirmative. According to clinicaltrials.gov, the medical trial in question is currently accepting participants - first posted on June 19th 2017 and last updated on June 6th 2022. 65 patients are sought at 9 distinct locations for this study."

Answered by AI

Does this clinical investigation offer enrollment to individuals over 30 years of age?

"Prospective participants must be aged 18-65 to join this trial. For those younger and older than the specified age range, there are 438 and 1169 clinical trials respectively that they may qualify for."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study Evaluating Safety and Efficacy of UCART123v1.2 in Patients With Relapsed/Refractory Acute Myeloid Leukemia

2017. "Study Evaluating Safety and Efficacy of UCART123v1.2 in Patients With Relapsed/Refractory Acute Myeloid Leukemia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03190278.

All > Acute Myeloid Leukemia > Aml