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CAR T-cell Therapy

TAK-007 for Non-Hodgkin's Lymphoma

Phase 2

Recruiting

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

+16 more

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.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

TakedaLead Sponsor

1,203 Previous Clinical Trials

4,177,760 Total Patients Enrolled

Study DirectorStudy DirectorTakeda

1,211 Previous Clinical Trials

489,088 Total Patients Enrolled

Media Library

TAK-007 (CAR T-cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05020015 — Phase 2

B-Cell Non-Hodgkin Lymphoma Research Study Groups: Part 1: Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells, Part 1: Dose Expansion: Cohort 2A (iNHL 3L+): TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK Cells, Part 2: Cohort 1- LBCL, Part 1: Dose Expansion: Cohort 1A (LBCL 3L+): TAK-007 - 200×10^6/ 800×10^6 CD19-CAR+ Viable NK Cells, Part 1: Dose Expansion: Cohort 1B (LBCL 3L+): TAK-007- 800×10^6 CD19-CAR+ Viable NK Cells, Part 1: Dose Expansion: Cohort 1C (LBCL 2L): TAK-007- 800×10^6 CD19-CAR+ Viable NK Cells, Part 2: Cohort 2- iNHL, Part 1: Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells

B-Cell Non-Hodgkin Lymphoma Clinical Trial 2023: TAK-007 Highlights & Side Effects. Trial Name: NCT05020015 — Phase 2

TAK-007 (CAR T-cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05020015 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Approximately how many people have enrolled in the research program?

"To commence this trial, 242 suitable people must be enrolled. Applicants have the option to join at Northside Hospital in Atlanta or DUHS Duke Blood Cancer Center in Durham, both located in the USA."

Answered by AI

To what extent do Chemotherapy Agents pose a risk to individuals?

"The risk associated with Chemotherapy Agents received a score of 2, as the clinical data currently available reflects some safety information but does not provide any evidence for efficacy."

Answered by AI

Are there plentiful Canadian facilities participating in this investigation?

"Northside Hospital in Atlanta, DUHS Duke Blood Cancer Center in Durham, and Sylvester Comprehensive Cancer Center University of Miami Hospitals and Clinics in Miami are amongst the 27 potential sites for this trial."

Answered by AI

Are there still openings available to partake in this research project?

"Affirmative. Clinicaltrials.gov data shows that this trial is actively recruiting, having first been posted on November 22nd 2021 and most recently updated on the 10th of November 2022. The research team seeks 242 individuals from 27 various medical centres."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2021. "A Study of TAK-007 in Adults With Relapsed or Refractory (r/r) B-cell Non-Hodgkin Lymphoma (NHL)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05020015.