Trial Outcomes & Findings for CD3/CD19 Depleted or CD3 Depleted/CD56 Selected Haploidentical Donor Natural Killer (NK) Cell Based Therapy for AML Patients Not in CR (NCT NCT03152526)

Results Overview

Both the number of patients with leukemia in complete remission and the number of patients with leukemia not in complete remission will be reported. Leukemia remission status will be assessed according to the Revised Recommendations of The International Working Group (J Clin Oncol 21:4642-4649, 2003).

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

1 participants

Primary outcome timeframe

On Day+42 (+/- 3 days) after NK cell infusion

Results posted on

2020-07-09

Participant Flow

Participant milestones

Participant milestones
Measure	CD3-/CD19- NK Cells Followed by IL-2 After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD19- NK Cell Product (NK Cell, CD3-/CD56+: ≥ 3-fold enrichment) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).	CD3-/CD56+ NK Cells Followed by IL-2 After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD56+ Purified NK Cell Product (NK Cell, CD3-/CD56+: ≥ 70%) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).
Overall Study STARTED	0	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	CD3-/CD19- NK Cells Followed by IL-2 After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD19- NK Cell Product (NK Cell, CD3-/CD56+: ≥ 3-fold enrichment) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).	CD3-/CD56+ NK Cells Followed by IL-2 After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD56+ Purified NK Cell Product (NK Cell, CD3-/CD56+: ≥ 70%) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CD3-/CD19- NK Cells Followed by IL-2 After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD19- NK Cell Product (NK Cell, CD3-/CD56+: ≥ 3-fold enrichment) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).	CD3-/CD56+ NK Cells Followed by IL-2 n=1 Participants After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD56+ Purified NK Cell Product (NK Cell, CD3-/CD56+: ≥ 70%) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).	Total n=1 Participants Total of all reporting groups
Age, Customized Participant age (years)	—	52 years n=1 Participants	52 years n=1 Participants
Sex: Female, Male Female	—	1 Participants n=1 Participants	1 Participants n=1 Participants
Sex: Female, Male Male	—	0 Participants n=1 Participants	0 Participants n=1 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: On Day+42 (+/- 3 days) after NK cell infusion

Population: As a result of poor subject accrual (n=1), statistically relevant efficacy data cannot be defined according to the protocol.

Both the number of patients with leukemia in complete remission and the number of patients with leukemia not in complete remission will be reported. Leukemia remission status will be assessed according to the Revised Recommendations of The International Working Group (J Clin Oncol 21:4642-4649, 2003).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day+7 to Day+42 after NK cell infusion

Population: As a result of poor subject accrual (n=1), statistically relevant efficacy data cannot be defined according to the protocol.

Successful expansion and persistence of NK cells is defined as ≥ 100 donor derived NK cells per µl blood.

Outcome measures

Outcome data not reported

Adverse Events

CD3-/CD19- NK Cells Followed by IL-2

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CD3-/CD56+ NK Cells Followed by IL-2

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	CD3-/CD19- NK Cells Followed by IL-2 After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD19- NK Cell Product (NK Cell, CD3-/CD56+: ≥ 3-fold enrichment) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).	CD3-/CD56+ NK Cells Followed by IL-2 n=1 participants at risk After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD56+ Purified NK Cell Product (NK Cell, CD3-/CD56+: ≥ 70%) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).
Respiratory, thoracic and mediastinal disorders Serious adverse event	— 0/0 • 3 months No participants were enrolled on the CD3-/CD19- NK Cells arm, therefore no participants on this arm were at risk of adverse events.	100.0% 1/1 • Number of events 1 • 3 months No participants were enrolled on the CD3-/CD19- NK Cells arm, therefore no participants on this arm were at risk of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Serious adverse event	— 0/0 • 3 months No participants were enrolled on the CD3-/CD19- NK Cells arm, therefore no participants on this arm were at risk of adverse events.	100.0% 1/1 • Number of events 1 • 3 months No participants were enrolled on the CD3-/CD19- NK Cells arm, therefore no participants on this arm were at risk of adverse events.

Other adverse events

Other adverse events
Measure	CD3-/CD19- NK Cells Followed by IL-2 After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD19- NK Cell Product (NK Cell, CD3-/CD56+: ≥ 3-fold enrichment) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).	CD3-/CD56+ NK Cells Followed by IL-2 n=1 participants at risk After a preparative regimen (day -6 to day -1) of fludarabine and cyclophosphamide participants receive allogeneic CD3-/CD56+ Purified NK Cell Product (NK Cell, CD3-/CD56+: ≥ 70%) on Day 0, followed by administration of interleukin-2 (after the NK cell infusion every other day for a total of 6 doses).
Blood and lymphatic system disorders Febrile neutropenia	— 0/0 • 3 months No participants were enrolled on the CD3-/CD19- NK Cells arm, therefore no participants on this arm were at risk of adverse events.	100.0% 1/1 • 3 months No participants were enrolled on the CD3-/CD19- NK Cells arm, therefore no participants on this arm were at risk of adverse events.
General disorders Chills, edema limbs, fever, injection site reaction	— 0/0 • 3 months No participants were enrolled on the CD3-/CD19- NK Cells arm, therefore no participants on this arm were at risk of adverse events.	100.0% 1/1 • 3 months No participants were enrolled on the CD3-/CD19- NK Cells arm, therefore no participants on this arm were at risk of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnea, pneumonitis	— 0/0 • 3 months No participants were enrolled on the CD3-/CD19- NK Cells arm, therefore no participants on this arm were at risk of adverse events.	100.0% 1/1 • 3 months No participants were enrolled on the CD3-/CD19- NK Cells arm, therefore no participants on this arm were at risk of adverse events.
Vascular disorders Hypertension, hypotension	— 0/0 • 3 months No participants were enrolled on the CD3-/CD19- NK Cells arm, therefore no participants on this arm were at risk of adverse events.	100.0% 1/1 • 3 months No participants were enrolled on the CD3-/CD19- NK Cells arm, therefore no participants on this arm were at risk of adverse events.

Additional Information

Clinical Project Manager

Miltenyi Biotec

Phone: 617-218-0055

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Institution conducted study as an independent contractor, supervised by the PI. PI may publish results provided that 12 months have elapsed since the completion of the study and sponsor has not initiated publication of a study report and at least 30 days prior to submission sponsor receives a draft to review. This study did not result in any publications.
Publication restrictions are in place

Restriction type: OTHER