Genetically Modified T Cells for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: University of Pennsylvania

No Placebo Group

Trial Summary

What is the purpose of this trial?

Phase 1 open-label study to estimate the safety, manufacturing feasibility, and efficacy of intravenously administered, lentivirally transduced T cells expressing anti-CD123 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCRζ /4-1BB) costimulatory domains in Acute Myeloid Leukemia (AML) subjects.

Eligibility Criteria

This trial is for adults with Acute Myeloid Leukemia (AML) who haven't achieved remission or have relapsed, including after stem cell transplants. They must be over 18, have good organ function and performance status, not pregnant or breastfeeding, without severe active infections like HIV or hepatitis B/C, no history of certain heart conditions or other specific diseases.

Inclusion Criteria

My organs are functioning well.

- Creatinine ≤ 1.6 mg/dl

- ALT/AST must be ≤5 x upper limit of normal unless related to disease

See 14 more

Exclusion Criteria

I am HIV positive.

I do not have unstable heart rhythm issues.

My AML has returned and has a specific genetic feature (t(15:17)).

See 10 more

Treatment Details

Interventions

CART123 cells (CAR T-cell Therapy)
Cyclophosphamide (Alkylating agents)
Fludarabine (Anti-metabolites)

Trial OverviewThe study tests a new therapy where patients' T cells are modified to target AML cells and then put back into the body. It's combined with two chemotherapy drugs: cyclophosphamide and fludarabine. The goal is to see if this approach is safe and effective against AML.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment ArmExperimental Treatment1 Intervention

CART123 cells; cyclophosphamide; fludarabine