TAK-007 for Non-Hodgkin's Lymphoma

Recruiting in Palo Alto (17 mi)

+29 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Takeda

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study has 2 parts. The main aim of Part 1 is to check for side effects from TAK-007 in adults with relapsed or refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL), The main aim of Part 2 is to learn whether lymphoma disease responds to treatment with TAK-007 in adults with r/r B-cell NHL or iNHL. Participants will receive 3 days of chemotherapy to reduce a type of white blood cells called lymphocytes, in the blood. This is called lymphodepleting chemotherapy (LDC) or lymphodepletion. After LDC, patients will receive a single injection of TAK-007 or three weekly injections of TAK-007 (multi-dose injection). After this, participants will regularly visit the clinic for check-ups.

Eligibility Criteria

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.

Inclusion Criteria

I had CAR-T cell therapy targeting CD19 and saw some improvement.

I have had one prior treatment and meet specific criteria for Part 1 Cohort 1C.

I agree to give a sample of my tumor for the study.

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Exclusion Criteria

I haven't had certain transplants or cell therapies in the last 3 months.

My condition is a specific type of lymphoma or has changed from CLL/small lymphocytic lymphoma.

My total body weight is less than 40 kg.

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Treatment Details

Interventions

Chemotherapy Agents (Chemotherapy)
TAK-007 (CAR T-cell Therapy)

Trial OverviewThe 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.

Participant Groups

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.