Trial Outcomes & Findings for Phase 2 STIR Trial: Haploidentical Transplant and Donor Natural Killer Cells for Solid Tumors (NCT NCT02100891)

Last Updated: 2025-03-19

Results Overview

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

15 participants

Primary outcome timeframe

6 months

Results posted on

2025-03-19

Participant Flow

Trial closed early due to low enrollment.

Participant milestones

Participant milestones
Measure	Allogeneic HCT + Donor NK Cell Infusion Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Allogeneic HCT: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Donor NK Cell Infusion: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant.
Overall Study STARTED	15
Overall Study COMPLETED	15
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Phase 2 STIR Trial: Haploidentical Transplant and Donor Natural Killer Cells for Solid Tumors

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Allogeneic HCT + Donor NK Cell Infusion n=15 Participants Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Allogeneic HCT: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Donor NK Cell Infusion: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant.
Age, Categorical <=18 years	8 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	17.2 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	15 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	Allogeneic HCT + Donor NK Cell Infusion n=15 Participants Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Allogeneic HCT: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Donor NK Cell Infusion: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant.
Disease-control Rate	10 Participants

SECONDARY outcome

Timeframe: 1 year

Population: There were 15 subjects enrolled who received the intervention on this 1-armed study.

Number of subjects alive at 1 year post-HCT

Outcome measures

Outcome measures
Measure	Allogeneic HCT + Donor NK Cell Infusion n=15 Participants Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Allogeneic HCT: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Donor NK Cell Infusion: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant.
Overall Survival	11 Participants

SECONDARY outcome

Timeframe: Day +100

The presence of severe acute grades 3-4 GVHD by day +100

Outcome measures

Outcome measures
Measure	Allogeneic HCT + Donor NK Cell Infusion n=15 Participants Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Allogeneic HCT: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Donor NK Cell Infusion: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant.
Grades 3-4 GVHD	0 Participants

SECONDARY outcome

Timeframe: Day +100

Death from causes other than disease by day +100

Outcome measures

Outcome measures
Measure	Allogeneic HCT + Donor NK Cell Infusion n=15 Participants Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Allogeneic HCT: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Donor NK Cell Infusion: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant.
Non-relapse Mortality	0 Participants

SECONDARY outcome

Timeframe: 6 months

Alive without progression or relapse of disease by 6 months post-HCT

Outcome measures

Outcome measures
Measure	Allogeneic HCT + Donor NK Cell Infusion n=15 Participants Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Allogeneic HCT: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Donor NK Cell Infusion: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant.
Progression-free Survival	10 Participants

Adverse Events

Allogeneic HCT + Donor NK Cell Infusion

Serious events: 5 serious events

Other events: 1 other events

Deaths: 4 deaths

Serious adverse events

Serious adverse events
Measure	Allogeneic HCT + Donor NK Cell Infusion n=15 participants at risk Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Allogeneic HCT: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Donor NK Cell Infusion: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant.
General disorders Sepsis	20.0% 3/15 • Number of events 3 • All-Cause Mortality was assessed up to 1 year post-transplant; all adverse events were collected through 28 days from the NK cell infusion (through day +35 after transplant)
Respiratory, thoracic and mediastinal disorders Wheezing	6.7% 1/15 • Number of events 1 • All-Cause Mortality was assessed up to 1 year post-transplant; all adverse events were collected through 28 days from the NK cell infusion (through day +35 after transplant)
Musculoskeletal and connective tissue disorders Myalgias	6.7% 1/15 • Number of events 1 • All-Cause Mortality was assessed up to 1 year post-transplant; all adverse events were collected through 28 days from the NK cell infusion (through day +35 after transplant)
General disorders Febrile neutropenia	6.7% 1/15 • Number of events 1 • All-Cause Mortality was assessed up to 1 year post-transplant; all adverse events were collected through 28 days from the NK cell infusion (through day +35 after transplant)
Immune system disorders Infection NOS	6.7% 1/15 • Number of events 1 • All-Cause Mortality was assessed up to 1 year post-transplant; all adverse events were collected through 28 days from the NK cell infusion (through day +35 after transplant)

Other adverse events

Other adverse events
Measure	Allogeneic HCT + Donor NK Cell Infusion n=15 participants at risk Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Allogeneic HCT: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant. Donor NK Cell Infusion: Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant.
General disorders Fever	6.7% 1/15 • Number of events 2 • All-Cause Mortality was assessed up to 1 year post-transplant; all adverse events were collected through 28 days from the NK cell infusion (through day +35 after transplant)
General disorders Fatigue	6.7% 1/15 • Number of events 1 • All-Cause Mortality was assessed up to 1 year post-transplant; all adverse events were collected through 28 days from the NK cell infusion (through day +35 after transplant)
Gastrointestinal disorders Abdominal Pain	6.7% 1/15 • Number of events 1 • All-Cause Mortality was assessed up to 1 year post-transplant; all adverse events were collected through 28 days from the NK cell infusion (through day +35 after transplant)

Additional Information

Monica Thakar, MD - Professor of Pediatrics

Fred Hutchinson Cancer Center

Phone: 206-667-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place