← Trials/Trial dossier/NCT01478074

WithdrawnPhase 1

ALT-801-activated Natural Killer Cells After FLAG Induction for Acute Myeloid Leukemia

A Single-center Open-label Phase I Study of ALT-801 for ex Vivo Maturation and in Vivo Retargeting of Haploidentical Natural Killer Cells Delivered Following Fludarabine, Cytarabine, and G-CSF in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Lead sponsor

Altor BioScience

Asset

Pemvidutide

Subcutaneous · GLP-1 / glucagon dual

Listed sites

1

Recruiting sites

Enrollment

actual

Study population

Oncology

Key I/E criterion

Primary endpoints

Maximum tolerated dose of NK cellsTreatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT01478074
Org study IDCA-ALT-801-02-08

Timeline

Milestones

Study first posted2011-11-23estimated
Last update posted2014-01-03estimated
Study start2011-11 (month precision)
Primary completion2013-10estimated (month precision)
Study completion2013-11actual (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Oncology

Eligibility

Who can enroll

Minimum age2 Years
Maximum age59 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

Recipient Inclusion Criteria:

1. Patients with relapsed AML, including those with CNS disease or previous hematopoietic stem cell transplantation, or primary refractory AML (primary AML that has failed remission to at least two cycles of induction therapy)

2. For patients of Cohorts 2 to 4, availability of a haploidentical family peripheral blood stem cell donor selected for best possible KIR reactivity

3. Patient is between 2 and 59 years of age, inclusive

4. Patient must have recovered from the treatment-related toxicities of prior cytotoxic agents received in the 4 weeks prior to beginning treatment on this protocol, with the exception of cytopenias resulting from persistent disease, and alopecia

5. Zubrod performance scale (Refer to Appendix C) ≤ 2 or Lansky (Refer to Appendix D) > 60

6. Adequate renal function defined as:

For adults serum creatinine < 2 mg/dL
For children serum creatinine < 2 mg/dL or < 2 times upper limit of normal (ULN) for age (which ever is less) If abnormal creatinine level, 24h creatinine clearance > 60 mL/min/1.73m^2

7. Adequate liver function, defined as: Total bilirubin ≤ 2 mg/dL and SGPT (ALT) ≤ 2.5 x ULN for age (unless Gilbert's disease or abnormal liver function due to primary disease)

8. Pulmonary symptoms controlled by medication and pulse oximetry> 92% room air

9. New York Heart Association classification < III

10. Negative serum test to rule out pregnancy within 2 weeks prior to registration in females of childbearing potential (non childbearing potential defined as premenarchal, greater than one year post-menopausal, or surgically sterilized)

11. Sexually active males and females of childbearing potential must agree to use a form of contraception considered effective and medically acceptable by the Investigator

12. Negative serology for human immunodeficiency virus (HIV)

Recipient Exclusion Criteria:

1. Investigational therapies in the 4 weeks prior to beginning treatment on this protocol

2. Congestive heart failure < 6 months prior to screening

3. Unstable angina pectoris < 6 months prior to screening

4. Myocardial infarction < 6 months prior to screening

Donor Inclusion Criteria:

1. Related to recipient (sibling, parent, offspring, offspring of a sibling)

2. HLA-haploidentical to recipient (need not be re-tested if already performed previously, provided copies of the original results are available)

3. Able and willing to undergo apheresis

4. Willing to donate blood for baseline chimerism assessment

5. Negative serum test to rule out pregnancy within two weeks prior to registration in females of childbearing potential (non childbearing potential defined as premenarchal, greater than one year post-menopausal, or surgically sterilized)

6. Donor must meet institutional eligibility criteria for allogeneic blood stem cell donation including infectious disease screening panel (Hepatitis B, Hepatitis C, HIV, CMV, and West Nile Virus) and CBC, differential and platelet studies

7. Donor must meet stem cell donor eligibility criteria as set forth in 21 CFR 1271 subpart C

8. The preferred Donor will be selected as the most alloreactive of the available haploidentical related donors on the basis of predicted NK cell alloreactivity using Recipient and Donor HLA type. If necessary, the best of equally alloreactive donors will be determined by Donor KIR type. NK alloreactivity is defined as o A KIR gene is present on the Donor NK cells for which

the HLA haplotype (KIR ligand) for the KIR receptor in question is absent in the Recipient, and
the HLA haplotype (KIR ligand) for the KIR receptor in question is present in the Donor

Donor Exclusion Criteria:

1. Active infection (defined as on antimicrobial therapy and/or febrile)

2. Pregnant females

3. Breast-feeding females

Endpoints (7)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
3
Other clinical outcomes
2
Other (unclassified)
2

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Maximum tolerated dose of NK cells

Time frame:18 months

descriptive

Primary/protocol endpoint

Safety of delivering NK cells and ALT-801 in combination with FLAG

Time frame:6 months after study completes accrual

Treatment-emergent AEs (any)

threshold achievement, event

Secondary/protocol endpoint

ALT-801 immunogenicity

Time frame:6 months after study completes accrual

Immunogenicity (ADA)

descriptive

Other clinical outcomes

2 endpoints
Secondary/protocol endpoint/low confidence

Overall response to this regimen

Time frame:6 months after study completes accrual

categorical status, improvement

Secondary/protocol endpoint/low confidence

Rate of stem cell transplantation and the time-to-transplantation

Time frame:6 months after study completes accrual

time to event, event

Other (unclassified)

2 endpoints
Secondary/protocol endpoint/low confidence

Activation status of NK cells following activation with ALT-801

Time frame:6 months after study completes accrual

descriptive

Secondary/protocol endpoint/low confidence

In vivo persistence and function of haploidentical NK cells activated with ALT-801.

Time frame:6 months after study completes accrual

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.