PRGN-3006 T Cells for Acute Myeloid Leukemia

Phase-Based Progress Estimates
Mayo Clinic, Rochester, MNAcute Myeloid Leukemia+1 MorePRGN-3006 T Cells - Drug
All Sexes
What conditions do you have?

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.

Eligible Conditions
  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome

Treatment Effectiveness

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: Up to 15 years

Absolute Lymphocyte Count (ALC)
Day 28
Rate of Absolute Neutrophil Count Recovery
Month 12
Number of PRGN-3006 T Cells
Number of Participants who Experience Treatment Related Adverse Events (AEs)
Up to 15 years
Disease Progression in AML Participants
Disease Response in MDS Patients
Up to Day 42
Number of Participants who Experience Dose Limiting Toxicities (DLTs)

Trial Safety

Trial Design

1 Treatment Group

Dose Escalation and Dose Expansion of PRGN-3006
1 of 1

Experimental Treatment

88 Total Participants · 1 Treatment Group

Primary Treatment: PRGN-3006 T Cells · No Placebo Group · Phase 1

Dose Escalation and Dose Expansion of PRGN-3006
Experimental Group · 1 Intervention: PRGN-3006 T Cells · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 15 years

Who is running the clinical trial?

Precigen, IncLead Sponsor
4 Previous Clinical Trials
219 Total Patients Enrolled
H. Lee Moffitt Cancer Center and Research InstituteLead Sponsor
510 Previous Clinical Trials
126,841 Total Patients Enrolled
PGEN Therapeutics, Inc., a subsidiary of Precigen, Inc.Lead Sponsor
2 Previous Clinical Trials
119 Total Patients Enrolled
David A Sallman, MDPrincipal InvestigatorH. Lee Moffitt Cancer Center and Research Institute
2 Previous Clinical Trials
105 Total Patients Enrolled
Nelli Bejanyan, MDPrincipal InvestigatorMoffitt Cancer Center
2 Previous Clinical Trials
69 Total Patients Enrolled
Amy R. Lankford, PhDStudy DirectorPrecigen, Inc
1 Previous Clinical Trials
71 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 13 Total Inclusion Criteria

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Frequently Asked Questions

Are there any openings still available to participate in this experiment?

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

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

What is the current enrollment size of this clinical trial?

"Affirmative. 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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.