CAR NK Cell Therapy for Acute Myeloid Leukemia or Myelodysplastic Syndrome

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Nkarta Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?This is a single-arm, open-label, multi-center, Phase 1 study to determine safety and tolerability of an experimental therapy called NKX101 (allogeneic CAR NK cells targeting NKG2D ligands) in patients with relapsed/refractory AML or intermediate, high and very high risk relapsed/refractory MDS.

Eligibility Criteria

This trial is for adults with relapsed/refractory Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndromes (MDS). Participants must have had 1-2 prior treatments, a white blood cell count ≤25 × 10^9/L, and platelets ≥30,000/uL. They need functioning organs and an ECOG status ≤2. A suitable donor for leukapheresis is required if haplo-matched. Birth control use is mandatory.

Inclusion Criteria

I've had 1 or 2 treatments for myelodysplastic syndrome.

I have a family member willing and able to donate stem cells.

I have MDS that came back or didn't respond to treatment.

I can take care of myself but might not be able to do heavy physical work.

My MDS is classified as intermediate, high, or very high risk.

My AML has returned or didn't respond to treatment, including if it's MRD+.

I have had 1 or 2 treatments for leukemia.

Exclusion Criteria

My leukemia is specifically acute promyelocytic with a certain genetic feature.

I have leukemia that has spread to my brain or spinal cord.

I haven't taken any AML/MDS specific drugs recently.

My white blood cell count is very high, indicating my disease is progressing quickly.

I still have side effects from past treatments that are not mild.

Treatment Details

NKX101 - CAR NK cell therapy is being tested in this Phase 1 study to see how safe and tolerable it is for patients with AML or MDS that has come back or didn't respond to treatment. It's given intravenously and targets NKG2D ligands on cancer cells.

1Treatment groups

Experimental Treatment

Group I: NKX101 - CAR NK cell therapyExperimental Treatment1 Intervention

All subjects in Part 1 will receive lymphodepletion with fludarabine/cyclophosphamide followed by 3 or 2 (Regimen A or B, respectively) weekly doses of NKX101. Subjects in Part 2 will receive lymphodepletion with either fludarabine/cyclophosphamide or fludarabine/cytarabine (ara-C), or if the optional arm is opened, lymphodepletion with fludarabine/cyclophosphamide and decitabine, followed by 3 weekly doses of NKX101. Part 2: unrelated off-the-shelf donor derived NKX101 will be used.