TAK-007 for Non-Hodgkin's Lymphoma

Recruiting at 29 trial locations

Overseen By Takeda Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Takeda

Must be taking: Anti-CD20 mAb

Must not be taking: Investigational products

Disqualifiers: CNS involvement, Burkitt lymphoma, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

Duration: 3 weeks

27 Participants Needed

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.

Research Team

Study Director

Principal Investigator

Takeda

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.

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

Participants receive lymphodepleting chemotherapy intravenously for 3 days to reduce lymphocytes before TAK-007 administration

1 week

3 visits (in-person)

Treatment

Participants receive TAK-007, either as a single-dose or multi-dose regimen, to evaluate safety and efficacy

3 weeks

3-4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Regular visits (in-person)

Long-term Follow-up

Participants enroll in a separate long-term follow-up study for continued safety assessments

Up to 15 years

Treatment Details

Interventions

• Chemotherapy Agents
• TAK-007

Trial Overview 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.

Participant Groups

Group I: Part 2: Cohort 2- iNHL Experimental Treatment 2 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- LBCL Experimental Treatment 2 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 Cells Experimental Treatment 2 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 Cells Experimental Treatment 2 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 Cells Experimental Treatment 2 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 VI: Part 1: Dose Expansion: Cohort 1A (LBCL 3L+): TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK Cells Experimental Treatment 2 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 Cells Experimental Treatment 2 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 Cells Experimental Treatment 2 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.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier