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CAR T-cell Therapy

TAK-007 for Non-Hodgkin's Lymphoma

Phase 2

Waitlist Available

Research Sponsored by Takeda

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 60 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new cancer drug to see if it is safe and effective in adults with relapsed or refractory B-cell Non-Hodgkin Lymphoma or indolent non-Hodgkin lymphoma.

Who is the study for?

This trial is for adults with B-cell Non-Hodgkin Lymphoma that has come back or didn't respond to treatment. They should be expected to live at least 12 weeks, be fairly active (ECOG status of 0 or 1), and have had at least two prior treatments. Their cancer must show up on scans and they can't weigh less than 40 kg or have lymphoma in their brain, certain other lymphomas, a recent history of other cancers, serious infections, recent transplants or CAR-T therapy.

What is being tested?

The study tests TAK-007's safety and its effect on reducing lymphomas in patients who've relapsed or are refractory. It includes chemotherapy before a single dose of TAK-007. Part one focuses on side effects; part two checks if the cancer shrinks or disappears after treatment.

What are the potential side effects?

While specific side effects for TAK-007 aren't listed here, similar therapies may cause immune reactions, infusion-related symptoms like fever/chills, fatigue, nausea/vomiting from chemo pre-treatment and increased risk of infection due to lowered white blood cell counts.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 60 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 60 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 60 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Number of Participants with Adverse Events (AEs)

Part 1: Number of Participants with Clinically Significant Changes in Laboratory Parameters

Part 1: Number of Participants with Clinically Significant Changes in Vital Signs

+1 more

Secondary study objectives

Part 1 and Part 2: Complete Response (CR) per Investigator

Part 1 and Part 2: Concentration of Interleukin (IL)-15 and Other Soluble Immune Factors in Plasma Over Time

Part 1 and Part 2: Duration of Response (DOR) per Investigator

+9 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

8Treatment groups

Experimental Treatment

Group I: Part 2: Cohort 2- iNHLExperimental Treatment2 Interventions

Participants with iNHL will be enrolled in this cohort to receive lymphodepleting chemotherapy per day intravenously for 3 days followed by TAK-007 at the RP2D, intravenously.

Group II: Part 2: Cohort 1- LBCLExperimental Treatment2 Interventions

Participants with LBCL will be enrolled in this cohort to receive lymphodepleting chemotherapy per day intravenously for 3 days followed by TAK-007 at the RP2D, intravenously.

Group III: Part 1: Dose Expansion: Cohort 2A (iNHL 3L+): TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK CellsExperimental Treatment2 Interventions

Participants with r/r Indolent Non-Hodgkin Lymphoma (iNHL) will receive lymphodepleting chemotherapy per day intravenously for 3 days followed by TAK-007 - 200×10\^6/ 800×10\^6 CD19-CAR+ viable NK cells, single-dose, intravenously, once on Day 0 to determine RP2D.

Group IV: Part 1: Dose Expansion: Cohort 1C (LBCL 2L): TAK-007- 800×10^6 CD19-CAR+ Viable NK CellsExperimental Treatment2 Interventions

Participants with r/r Large B-cell Lymphoma (LBCL) will receive lymphodepleting chemotherapy per day intravenously for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, intravenously, once on Days 0, 7 and 14 to determine RP2D.

Group V: Part 1: Dose Expansion: Cohort 1B (LBCL 3L+): TAK-007- 800×10^6 CD19-CAR+ Viable NK CellsExperimental Treatment2 Interventions

Group VI: Part 1: Dose Expansion: Cohort 1A (LBCL 3L+): TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK CellsExperimental Treatment2 Interventions

Participants with r/r Large B-cell Lymphoma (LBCL) will receive lymphodepleting chemotherapy per day intravenously for 3 days followed by TAK-007 - 200×10\^6/ 800×10\^6 CD19-CAR+ viable NK cells, single-dose, intravenously, once on Day 0 to determine RP2D.

Group VII: Part 1: Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK CellsExperimental Treatment2 Interventions

Participants will receive lymphodepleting chemotherapy per day intravenously for 3 days followed by TAK-007 - 800×10\^6 CD19-CAR+ viable NK cells, single-dose, intravenously, once on Day 0.

Group VIII: Part 1: Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK CellsExperimental Treatment2 Interventions

Participants will receive lymphodepleting chemotherapy per day intravenously for 3 days followed by TAK-007 200×10\^6 anti-CD19 chimeric antigen receptor (CD19-CAR+) viable NK cells, single-dose, intravenously, once on Day 0.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Chemotherapy Agents

2021

Completed Phase 2

~20

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