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CAR T-cell Therapy

CAR T Cell Therapy for AML and MDS

Phase 1

Recruiting

Led By David A Sallman, MD

Research Sponsored by Precigen, Inc

Eligibility Criteria Checklist

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

Must have

Karnofsky performance status score ≥60%

Participants must be diagnosed with either relapsed or refractory AML (including extramedullary disease), MRD-positive AML, or higher risk MDS

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months post treatment

Awards & highlights

Study Summary

This trial will test a new CAR T cell therapy for safety and to find the best dose in patients with relapsed or recurrent AML or high-risk MDS.

Who is the study for?

Adults with relapsed or refractory acute myeloid leukemia (AML), MRD-positive AML, or high-risk MDS can join. They must have a certain level of physical fitness, organ function, and no need for oxygen support. Participants should not be pregnant and must agree to contraception. Those who've had bone marrow transplants are eligible if they meet specific conditions.Check my eligibility

What is being tested?

The trial is testing PRGN-3006 T Cells, which are modified immune cells designed to target and kill cancer cells in patients with certain types of blood cancers like AML and MDS.See study design

What are the potential side effects?

Potential side effects may include reactions related to the immune system's response to the modified T cells, such as fever, fatigue, inflammation in various organs, or symptoms similar to an infection.

Eligibility Criteria

Inclusion Criteria

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

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I can care for myself but may need occasional help.

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My condition is either a relapse or resistant AML, MRD-positive AML, or high-risk MDS.

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My kidney function, measured by creatinine clearance, is adequate.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Number of Participants who Experience Dose Limiting Toxicities (DLTs)

Number of Participants who Experience Treatment Emergent Adverse Events (TEAEs)

Secondary outcome measures

Absolute Lymphocyte Count (ALC)

Disease Progression in AML Participants

Disease Response in MDS Patients

+2 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Dose Escalation and Dose Expansion of PRGN-3006Experimental Treatment1 Intervention

Participants will be treated in dose expansion phase to evaluate the safety and efficacy of the identified dose of PRGN-3006.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Precigen, IncLead Sponsor

5 Previous Clinical Trials

255 Total Patients Enrolled

H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor

543 Previous Clinical Trials

135,394 Total Patients Enrolled

PGEN Therapeutics, Inc., a subsidiary of Precigen, Inc.Lead Sponsor

2 Previous Clinical Trials

109 Total Patients Enrolled

Media Library

PRGN-3006 T Cells (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT03927261 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Dose Escalation and Dose Expansion of PRGN-3006

Acute Myeloid Leukemia Clinical Trial 2023: PRGN-3006 T Cells Highlights & Side Effects. Trial Name: NCT03927261 — Phase 1

PRGN-3006 T Cells (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03927261 — 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 openings still available to participate in this experiment?

"According to clinicaltrials.gov, this research endeavor is presently seeking participants and has been listed since May 20th 2019 with its most recent update on August 2nd 2022."

Answered by AI

What objectives is this trial attempting to meet?

"According to the study sponsor, PGEN Therapeutics Inc., a subsidiary of Precigen, Inc., their primary outcome metric over 12 months is measuring Dose Limiting Toxicities (DLTs). Additionally, they are assessing secondary outcomes such as disease response in MDS patients by International Working Group 2006 Criteria and Disease Progression in AML Patients using ELN Response Criteria. They will also document Complete PRGN-3006 T cells remission with partial hematological recovery alongside Number of PRGN-3006 T Cells present after treatment with PRGN-3006."

Answered by AI

What precautions should be taken when utilizing PRGN-3006 T Cells?

"The safety of PRGN-3006 T Cells is likely to be well documented given that this a Phase 1 trial; thus, it has been assigned a score of 1 according to our team at Power."

Answered by AI

What is the current enrollment size of this clinical trial?

"Affirmative. Clinicaltrials.gov indicates that this medical experiment was first advertised on May 20th 2019 and last modified on August 2nd 2022, with a target of 88 participants over two different locations being sought out."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS

2019. "PRGN-3006 Adoptive Cellular Therapy for CD33-Positive Relapsed or Refractory AML, MRD Positive AML or Higher Risk MDS". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03927261.

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