Trial Outcomes & Findings for A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL) (NCT NCT05020015)

NCT ID: NCT05020015

Last Updated: 2025-08-12

Results Overview

An adverse event (AE) is defined as any untoward medical occurrence in a clinical investigation participant administered a drug; it does not necessarily have to have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (e.g., a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a study intervention or medicinal product or any existing event that worsens in either intensity or frequency following exposure to the study intervention or medicinal product.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

27 participants

Primary outcome timeframe

Up to 24 months

Results posted on

2025-08-12

Participant Flow

Participants took part in the investigative sites in the United States (US) from 12 November 2021 to 01 July 2024 (data cut off). The study is ongoing.

Participants with relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL), including large B-cell lymphoma (LBCL) participants who have failed ≥2 prior systemic therapies (i.e., third or higher line \[3L+\] treatment) and indolent non-Hodgkin lymphoma (iNHL) participants who have failed ≥2 prior systemic therapies (3L+) were included in this study. Part 2 will no longer be initiated and conducted as per the latest protocol amendment for this study.

Participant milestones

Participant milestones
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells Participants received lymphodepleting chemotherapy per day intravenously (IV) for 3 days followed by TAK-007 200×10\^6 anti-CD19 chimeric antigen receptor (CD19-CAR+) viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine recommended phase 2 dose (RP2D).	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
Overall Study STARTED	3	6	11	7
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	3	6	11	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells Participants received lymphodepleting chemotherapy per day intravenously (IV) for 3 days followed by TAK-007 200×10\^6 anti-CD19 chimeric antigen receptor (CD19-CAR+) viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine recommended phase 2 dose (RP2D).	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
Overall Study Ongoing on study	1	3	4	7
Overall Study Death	2	3	4	0
Overall Study Withdrawal by Subject	0	0	1	0
Overall Study Reason Not Specified	0	0	2	0

Baseline Characteristics

A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells n=3 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=11 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=7 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Total n=27 Participants Total of all reporting groups
Age, Continuous	63.0 years STANDARD_DEVIATION 5.29 • n=5 Participants	61.5 years STANDARD_DEVIATION 9.01 • n=7 Participants	63.2 years STANDARD_DEVIATION 10.87 • n=5 Participants	66.6 years STANDARD_DEVIATION 10.58 • n=4 Participants	63.7 years STANDARD_DEVIATION 9.62 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants	3 Participants n=4 Participants	19 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants	6 Participants n=4 Participants	25 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	7 Participants n=4 Participants	24 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Population: Safety Analysis Set included all participants who received TAK-007 administration.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells n=3 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=10 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=7 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
Number of Participants With Treatment Emergent Adverse Events (TEAEs)	3 Participants	6 Participants	10 Participants	7 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Population: Safety Analysis Set included all participants who received TAK-007 administration.

Laboratory parameters included hematology, clinical chemistry, serum immunoglobulin and urinalysis tests.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells n=3 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=10 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=7 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
Number of Participants With Clinically Significant Changes in Laboratory Parameters Creatinine	0 Participants	1 Participants	2 Participants	1 Participants
Number of Participants With Clinically Significant Changes in Laboratory Parameters Hemoglobin	2 Participants	5 Participants	7 Participants	2 Participants
Number of Participants With Clinically Significant Changes in Laboratory Parameters Leukocytes	3 Participants	5 Participants	10 Participants	7 Participants
Number of Participants With Clinically Significant Changes in Laboratory Parameters Lymphocytes	3 Participants	6 Participants	7 Participants	7 Participants
Number of Participants With Clinically Significant Changes in Laboratory Parameters Neutrophils	3 Participants	6 Participants	10 Participants	7 Participants
Number of Participants With Clinically Significant Changes in Laboratory Parameters Platelets	2 Participants	3 Participants	4 Participants	3 Participants
Number of Participants With Clinically Significant Changes in Laboratory Parameters Alanine aminotransferase (ALT)	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Changes in Laboratory Parameters Albumin	1 Participants	3 Participants	2 Participants	1 Participants
Number of Participants With Clinically Significant Changes in Laboratory Parameters Aspartate aminotransferase (AST)	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Changes in Laboratory Parameters Bilirubin	0 Participants	1 Participants	0 Participants	0 Participants
Number of Participants With Clinically Significant Changes in Laboratory Parameters Estimated glomerular filtration rate (GFR)	1 Participants	2 Participants	3 Participants	2 Participants
Number of Participants With Clinically Significant Changes in Laboratory Parameters Potassium	0 Participants	0 Participants	1 Participants	0 Participants
Number of Participants With Clinically Significant Changes in Laboratory Parameters Sodium	1 Participants	1 Participants	0 Participants	1 Participants
Number of Participants With Clinically Significant Changes in Laboratory Parameters Immunoglobulin G	0 Participants	1 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Up to 24 months

Population: Safety Analysis Set included all participants who received TAK-007 administration.

Vital signs included body temperature (oral or tympanic measurement), sitting blood pressure (after the participant had rested for at least 5 minutes), and pulse rate (beats per minute \[bpm\]).

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells n=3 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=10 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=7 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
Number of Participants With Notable Changes in Vital Signs	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 24 months

Population: Modified Intent-to-Treat (mITT) set included all participants who received TAK-007 administration.

ORR is defined as the percentage of participants with CR or PR as best response to treatment, determined by the investigator per the Lugano 2014 criteria after TAK-007 administration. CR is defined as percentage of participants with target nodes/nodal masses must regress to ≤1.5 cm in the longest transverse diameter of all lesions and no extralymphatic sites of disease. PR is defined as ≥50% decrease in sum of the product of the perpendicular diameters of up to 6 target measurable nodes and extranodal sites; absent/normal, regressed, but no increase in nonmeasured lesion; Spleen must have regressed by \>50% in length beyond normal.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells n=3 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=10 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=7 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
ORR Per Investigator	0 percentage of participants Interval 0.0 to 70.8	50.0 percentage of participants Interval 11.8 to 88.2	50.0 percentage of participants Interval 18.7 to 81.3	85.7 percentage of participants Interval 42.1 to 99.6

SECONDARY outcome

Timeframe: Up to 24 months

Population: mITT set included all participants who received TAK-007 administration.

CR is defined per Lugano 2014 criteria as percentage of participants with target nodes/nodal masses must regress to ≤1.5 cm in the longest transverse diameter of all lesions and no extralymphatic sites of disease.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells n=3 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=10 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=7 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
Complete Response (CR) Per Investigator	0 percentage of participants Interval 0.0 to 70.8	33.3 percentage of participants Interval 4.3 to 77.7	20.0 percentage of participants Interval 2.5 to 55.6	57.1 percentage of participants Interval 18.4 to 90.1

SECONDARY outcome

Timeframe: Up to 24 months

Population: mITT set included all participants who received TAK-007 administration. Overall number of participants analyzed is the number of participants with events.

DOR is defined only for participants who experienced objective response (complete response or partial response) and is the time from the date of first documented objective response to the date of first documented disease progression or death, whichever comes first. Participants not meeting the criteria for progression or death will be censored at the last disease assessment.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=3 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=5 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
Duration of Response (DOR) Per Investigator	—	4.9 months Interval 2.5 to 8.0	2.4 months Interval 0.0 to 4.5	4.9 months Interval 1.8 to 7.9

SECONDARY outcome

Timeframe: Up to 24 months

Population: mITT set included all participants who received TAK-007 administration.

Progression-free survival is defined as the time from TAK-007 administration to the date of disease progression or death from any cause, whichever comes first. Participants who do not have disease progression or die were censored at the last disease assessment. Participants who do not have postbaseline disease assessment prior to new anticancer therapy (excluding SCT) in the absence of death were censored at the dosing date of TAK-007.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells n=3 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=10 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=7 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
Progression-free Survival (PFS) Per Investigator	0.95 months Interval 0.85 to 1.02	2.23 months Interval 0.95 to 9.0	2.00 months Interval 0.03 to 5.55	5.62 months Interval 2.83 to 8.77

SECONDARY outcome

Timeframe: Up to 24 months

Population: mITT set included all participants who received TAK-007 administration.

OS is defined as the time from TAK-007 administration to the date of death. Participants who did not die were censored at the last contact date.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells n=3 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=10 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=7 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
Overall Survival (OS)	8.9 months Interval 1.7 to 20.3	NA months Interval 1.5 to 18.3 Median was not estimable due to insufficient number of participants with events.	8.4 months Interval 0.9 to 11.2	NA months Interval 6.0 to 13.8 Median was not estimable due to insufficient number of participants with events.

SECONDARY outcome

Timeframe: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24

Population: Cellular kinetic (CK) analysis set included all participants who received TAK-007 administration and had at least 1 plasma sample obtained and analyzed. Overall number of participants analyzed is the number of participants with data available for analysis.

The unit of measure 'copies per microgram' indicates copies of TAK-007 transgene per micrograms of genomic deoxyribonucleic acid (DNA).

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells n=2 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=8 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
Cmax - Maximum Observed Blood Concentration of TAK-007	1140 copies per microgram (µg) Standard Deviation 299	4730 copies per microgram (µg) Standard Deviation 8500	6540 copies per microgram (µg) Standard Deviation 4510	15800 copies per microgram (µg) Standard Deviation 28500

SECONDARY outcome

Timeframe: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24

Population: CK analysis set included all participants who received TAK-007 administration and had at least 1 plasma sample obtained and analyzed. Overall number of participants analyzed is the number of participants with data available for analysis.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells n=2 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=8 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
Tmax - Time of First Occurrence of Cmax of TAK-007	0.05 days Interval 0.04 to 0.05	0.31 days Interval 0.04 to 15.07	0.04 days Interval 0.04 to 0.05	0.05 days Interval 0.04 to 91.91

SECONDARY outcome

Timeframe: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells n=2 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=8 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
Tlast - Time of Last Measurable Concentration Above the Lower Limit of Quantitation of TAK-007	0.05 days Interval 0.04 to 0.05	5.39 days Interval 0.05 to 15.07	0.05 days Interval 0.04 to 13.83	6.87 days Interval 0.04 to 176.98

SECONDARY outcome

Timeframe: At 1 hour (±15 minutes) predose and postdose (Day 0) and once on Days 1, 3, 7, 10, 14, 21, 28/Month 1, Months 2, 3, 4, 6, 9, 12, 18, 24

The unit of measure 'day\*copies/µg' indicates day\*copies of TAK-007 transgene per µg of genomic DNA.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells n=2 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=8 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
AUClast - Area Under the Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration of TAK-007	25.9 day*copies/µg Standard Deviation 8.41	1100 day*copies/µg Standard Deviation 1130	8330 day*copies/µg Standard Deviation 12800	825000 day*copies/µg Standard Deviation 2240000

SECONDARY outcome

Timeframe: Baseline, pre-dose (Day 0) and post-dose at Days 1, 7, 14, 21, 28 and Months 2,3,4,6,9,12

Population: Pharmacodynamic Analysis Set included all participants from the safety analysis set who had a baseline and at least 1 postbaseline sample assessment. Number analyzed is the number of participants with data available for analysis at the specified timepoints.

Concentration of IL-15 and soluble immune factors (eg, Interferon (IFN)-gamma (γ) and IL-6) in plasma over time were reported.

Outcome measures

SECONDARY outcome

Timeframe: Pre-dose at Days -5, -4, 0 and post-dose at Days 0, 7, 28 and Months 2, 3, 4, 6, 9, 12

B-cell aplasia is defined as \<50 B-cells per microliters (µl) of blood.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells n=3 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=5 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=10 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=7 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration Post-dose at Month 6	—	20.0 percentage of participants	10.0 percentage of participants	42.9 percentage of participants
Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration Pre-dose at Day -5	100 percentage of participants	100 percentage of participants	70.0 percentage of participants	71.4 percentage of participants
Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration Pre-dose at Day -4	0 percentage of participants	20.0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration Pre-dose at Day 0	100 percentage of participants	100 percentage of participants	90.0 percentage of participants	57.1 percentage of participants
Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration Post-dose at 1 hr (+/-15 mins) at Day 0	100 percentage of participants	100 percentage of participants	90.0 percentage of participants	85.7 percentage of participants
Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration Post-dose at Day 7	100 percentage of participants	80.0 percentage of participants	80.0 percentage of participants	57.1 percentage of participants
Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration Post-dose at Day 28	33.3 percentage of participants	100 percentage of participants	80.0 percentage of participants	71.4 percentage of participants
Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration Post-dose at Month 2	—	40.0 percentage of participants	50.0 percentage of participants	71.4 percentage of participants
Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration Post-dose at Month 3	—	20.0 percentage of participants	20.0 percentage of participants	71.4 percentage of participants
Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration Post-dose at Month 4	—	20.0 percentage of participants	10.0 percentage of participants	28.6 percentage of participants
Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration Post-dose at Month 9	—	—	—	14.3 percentage of participants
Percentage of Participants With B-cell Aplasia Before and After TAK-007 Administration Post-dose at Month 12	—	—	—	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 12 months

Population: Safety Analysis Set included all participants who received TAK-007 administration. Number analyzed is the number of participants with data available for analysis at specified time points.

Outcome measures

Outcome measures
Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells n=3 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=6 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=10 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=7 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-HLA Antibodies: Prevalence at Day -5	0 percentage of participants	40.0 percentage of participants	10.0 percentage of participants	50.0 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-HLA Antibodies: Prevalence at Day -4	—	100 percentage of participants	—	—
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-HLA Antibodies: Incidence at Day 14	0 percentage of participants	33.3 percentage of participants	10.0 percentage of participants	42.9 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-HLA Antibodies: Incidence at Day 28	0 percentage of participants	60.0 percentage of participants	0 percentage of participants	42.9 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-HLA Antibodies: Incidence at Month 2	—	33.3 percentage of participants	20.0 percentage of participants	42.9 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-HLA Antibodies: Incidence at Month 3	—	50.0 percentage of participants	33.3 percentage of participants	33.3 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-HLA Antibodies: Incidence at Month 4	—	50.0 percentage of participants	0 percentage of participants	50.0 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-HLA Antibodies: Incidence at Month 6	—	0 percentage of participants	0 percentage of participants	50.0 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-HLA Antibodies: Incidence at Month 9	—	0 percentage of participants	—	50.0 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-HLA Antibodies: Incidence at Month 12	—	100 percentage of participants	—	0 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-CAR Antibodies: Prevalence at Day -5	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-CAR Antibodies: Incidence at Day 14	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-CAR Antibodies: Incidence at Day 28	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-CAR Antibodies: Incidence at Month 2	—	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-CAR Antibodies: Incidence at Month 3	—	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-CAR Antibodies: Incidence at Month 4	—	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-CAR Antibodies: Incidence at Month 6	—	0 percentage of participants	0 percentage of participants	0 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-CAR Antibodies: Incidence at Month 9	—	0 percentage of participants	—	0 percentage of participants
Percentage of Participants With Detectable Anti-human Leukocyte Antigen (HLA) and Anti-chimeric Antigen Receptor (CAR) Antibodies Before (Prevalence) and After (Incidence) TAK-007 Administration Over Time Anti-CAR Antibodies: Incidence at Month 12	—	0 percentage of participants	—	0 percentage of participants

SECONDARY outcome

Timeframe: Up to 60 months

Outcome measures

Outcome data not reported

Adverse Events

Dose Escalation: TAK-007: 200×10^6 CD19-CAR+ Viable NK Cells

Serious events: 3 serious events

Other events: 3 other events

Deaths: 2 deaths

Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells

Serious events: 4 serious events

Other events: 6 other events

Deaths: 3 deaths

Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007

Serious events: 8 serious events

Other events: 10 other events

Deaths: 5 deaths

Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells n=3 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 -200×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=5 Participants Participants received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, IV infusion, once on Day 0.	Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=10 Participants Participants with r/r LBCL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.	Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells n=7 Participants Participants with r/r iNHL received lymphodepleting chemotherapy per day IV for 3 days followed by TAK-007 at the dose level(s) selected based on the dose escalation part (800×10\^6 CD19-CAR+ viable NK cells), as a single-dose, IV infusion, once on Day 0 to determine RP2D.
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-15: Baseline	3.855 picograms per milliter (pg/mL) Standard Deviation 1.0355	3.991 picograms per milliter (pg/mL) Standard Deviation 1.6857	5.059 picograms per milliter (pg/mL) Standard Deviation 3.7114	2.802 picograms per milliter (pg/mL) Standard Deviation 1.0243
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-15: Pre-dose	33.737 picograms per milliter (pg/mL) Standard Deviation 8.6072	56.035 picograms per milliter (pg/mL) Standard Deviation 23.7989	34.547 picograms per milliter (pg/mL) Standard Deviation 14.5419	44.125 picograms per milliter (pg/mL) Standard Deviation 29.8318
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-15: Day 1	38.175 picograms per milliter (pg/mL) Standard Deviation 12.2965	51.992 picograms per milliter (pg/mL) Standard Deviation 26.7839	31.473 picograms per milliter (pg/mL) Standard Deviation 14.1248	38.546 picograms per milliter (pg/mL) Standard Deviation 26.6800
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-15: Day 7	18.288 picograms per milliter (pg/mL) Standard Deviation 8.7229	18.364 picograms per milliter (pg/mL) Standard Deviation 9.4926	15.775 picograms per milliter (pg/mL) Standard Deviation 9.6798	13.434 picograms per milliter (pg/mL) Standard Deviation 6.9273
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-15: Day 14	10.342 picograms per milliter (pg/mL) Standard Deviation 0.8935	9.384 picograms per milliter (pg/mL) Standard Deviation 3.2634	13.592 picograms per milliter (pg/mL) Standard Deviation 8.2004	10.707 picograms per milliter (pg/mL) Standard Deviation 3.8889
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-15: Day 21	7.915 picograms per milliter (pg/mL) Standard Deviation 1.8965	7.734 picograms per milliter (pg/mL) Standard Deviation 3.4047	9.900 picograms per milliter (pg/mL) Standard Deviation 6.4358	6.176 picograms per milliter (pg/mL) Standard Deviation 2.6925
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-15: Day 28	6.843 picograms per milliter (pg/mL) Standard Deviation NA Standard Deviation (SD) was not estimable for a single participant.	12.127 picograms per milliter (pg/mL) Standard Deviation 10.5958	5.200 picograms per milliter (pg/mL) Standard Deviation 2.0747	4.540 picograms per milliter (pg/mL) Standard Deviation 2.6362
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-15: Month 2	—	8.975 picograms per milliter (pg/mL) Standard Deviation 6.6271	4.242 picograms per milliter (pg/mL) Standard Deviation 1.9915	2.867 picograms per milliter (pg/mL) Standard Deviation 0.5611
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-15: Month 3	—	2.669 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.	4.149 picograms per milliter (pg/mL) Standard Deviation 1.9754	2.409 picograms per milliter (pg/mL) Standard Deviation 0.5595
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-15: Month 4	—	2.543 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.	3.820 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.	2.100 picograms per milliter (pg/mL) Standard Deviation 0.0263
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-15: Month 6	—	2.667 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.	2.575 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.	2.039 picograms per milliter (pg/mL) Standard Deviation 0.3939
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-15: Month 9	—	—	—	2.685 picograms per milliter (pg/mL) Standard Deviation 0.9093
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-15: Month 12	—	—	—	2.613 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IFN-g: Baseline	31.558 picograms per milliter (pg/mL) Standard Deviation 24.9063	22.738 picograms per milliter (pg/mL) Standard Deviation 9.8730	51.761 picograms per milliter (pg/mL) Standard Deviation 120.7897	37.396 picograms per milliter (pg/mL) Standard Deviation 52.8148
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IFN-g: Pre-dose	41.471 picograms per milliter (pg/mL) Standard Deviation 39.3018	35.890 picograms per milliter (pg/mL) Standard Deviation 36.3154	24.548 picograms per milliter (pg/mL) Standard Deviation 44.4643	96.015 picograms per milliter (pg/mL) Standard Deviation 150.1385
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IFN-g: Day 1	81.089 picograms per milliter (pg/mL) Standard Deviation 102.7746	50.657 picograms per milliter (pg/mL) Standard Deviation 42.5779	26.694 picograms per milliter (pg/mL) Standard Deviation 35.6445	172.001 picograms per milliter (pg/mL) Standard Deviation 347.0450
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IFN-g: Day 7	56.935 picograms per milliter (pg/mL) Standard Deviation 68.4453	44.602 picograms per milliter (pg/mL) Standard Deviation 15.4926	31.201 picograms per milliter (pg/mL) Standard Deviation 61.1626	29.970 picograms per milliter (pg/mL) Standard Deviation 20.1722
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IFN-g: Day 14	12.037 picograms per milliter (pg/mL) Standard Deviation 11.1691	70.825 picograms per milliter (pg/mL) Standard Deviation 70.1581	28.009 picograms per milliter (pg/mL) Standard Deviation 30.1577	155.058 picograms per milliter (pg/mL) Standard Deviation 233.9229
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IFN-g: Day 21	14.645 picograms per milliter (pg/mL) Standard Deviation 0.4215	57.785 picograms per milliter (pg/mL) Standard Deviation 76.0284	86.566 picograms per milliter (pg/mL) Standard Deviation 122.4368	51.144 picograms per milliter (pg/mL) Standard Deviation 46.2887
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IFN-g: Day 28	10.618 picograms per milliter (pg/mL) Standard Deviation 6.7349	36.489 picograms per milliter (pg/mL) Standard Deviation 54.2244	35.749 picograms per milliter (pg/mL) Standard Deviation 30.4532	57.836 picograms per milliter (pg/mL) Standard Deviation 34.8662
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IFN-g: Month 2	—	29.038 picograms per milliter (pg/mL) Standard Deviation 15.3845	27.540 picograms per milliter (pg/mL) Standard Deviation 18.7882	26.493 picograms per milliter (pg/mL) Standard Deviation 28.8072
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IFN-g: Month 3	—	10.806 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.	11.565 picograms per milliter (pg/mL) Standard Deviation 7.1666	9.016 picograms per milliter (pg/mL) Standard Deviation 5.5790
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IFN-g: Month 4	—	11.649 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.	13.138 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.	11.405 picograms per milliter (pg/mL) Standard Deviation 4.1568
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IFN-g: Month 6	—	35.829 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.	8.848 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.	15.160 picograms per milliter (pg/mL) Standard Deviation 11.9336
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IFN-g: Month 9	—	—	—	8.254 picograms per milliter (pg/mL) Standard Deviation 3.8536
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IFN-g: Month 12	—	—	—	12.077 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-6: Baseline	4.289 picograms per milliter (pg/mL) Standard Deviation 4.8094	17.169 picograms per milliter (pg/mL) Standard Deviation 17.2708	3.453 picograms per milliter (pg/mL) Standard Deviation 3.1142	4.129 picograms per milliter (pg/mL) Standard Deviation 7.7186
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-6: Pre-dose	4.814 picograms per milliter (pg/mL) Standard Deviation 4.5419	14.454 picograms per milliter (pg/mL) Standard Deviation 13.7658	2.309 picograms per milliter (pg/mL) Standard Deviation 2.0751	6.776 picograms per milliter (pg/mL) Standard Deviation 8.2117
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-6: Day 1	8.993 picograms per milliter (pg/mL) Standard Deviation 9.6177	17.015 picograms per milliter (pg/mL) Standard Deviation 16.4689	2.295 picograms per milliter (pg/mL) Standard Deviation 2.4267	158.548 picograms per milliter (pg/mL) Standard Deviation 406.9127
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-6: Day 7	9.236 picograms per milliter (pg/mL) Standard Deviation 12.7713	70.663 picograms per milliter (pg/mL) Standard Deviation 106.7221	3.169 picograms per milliter (pg/mL) Standard Deviation 3.8668	19.255 picograms per milliter (pg/mL) Standard Deviation 44.8587
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-6: Day 14	15.190 picograms per milliter (pg/mL) Standard Deviation 13.9920	60.895 picograms per milliter (pg/mL) Standard Deviation 68.6252	3.460 picograms per milliter (pg/mL) Standard Deviation 4.2615	16.038 picograms per milliter (pg/mL) Standard Deviation 38.8392
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-6: Day 21	3.984 picograms per milliter (pg/mL) Standard Deviation 4.0063	50.969 picograms per milliter (pg/mL) Standard Deviation 60.5058	4.365 picograms per milliter (pg/mL) Standard Deviation 3.7982	14.882 picograms per milliter (pg/mL) Standard Deviation 36.1528
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-6: Day 28	6.569 picograms per milliter (pg/mL) Standard Deviation 6.9839	39.678 picograms per milliter (pg/mL) Standard Deviation 74.2068	4.413 picograms per milliter (pg/mL) Standard Deviation 7.9900	7.208 picograms per milliter (pg/mL) Standard Deviation 16.5226
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-6: Month 2	—	5.774 picograms per milliter (pg/mL) Standard Deviation 8.1652	3.650 picograms per milliter (pg/mL) Standard Deviation 2.8818	1.317 picograms per milliter (pg/mL) Standard Deviation 1.3573
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-6: Month 3	—	0.000 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.	0.924 picograms per milliter (pg/mL) Standard Deviation 1.6003	1.489 picograms per milliter (pg/mL) Standard Deviation 1.4878
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-6: Month 4	—	0.000 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.	1.501 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.	0.473 picograms per milliter (pg/mL) Standard Deviation 0.9450
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-6: Month 6	—	0.000 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.	0.000 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.	0.954 picograms per milliter (pg/mL) Standard Deviation 0.8722
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-6: Month 9	—	—	—	0.000 picograms per milliter (pg/mL) Standard Deviation 0.0000
Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time IL-6: Month 12	—	—	—	0.000 picograms per milliter (pg/mL) Standard Deviation NA SD was not estimable for a single participant.