TAK-007 for Non-Hodgkin's Lymphoma

Not currently recruiting at 31 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how a new treatment, TAK-007, affects individuals with B-cell Non-Hodgkin's Lymphoma (NHL), particularly when other treatments have failed. Part 1 will identify any side effects, while Part 2 will assess the cancer's response to the treatment. Participants will first undergo chemotherapy to lower white blood cells, followed by TAK-007 injections. Suitable candidates for this trial are adults who have tried at least two different cancer treatments without success. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group of people.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that you should not have had any systemic anticancer treatment within 14 days before starting the trial's conditioning therapy.

Is there any evidence suggesting that TAK-007 is likely to be safe for humans?

Research has shown that TAK-007 is promising in safely treating certain types of non-Hodgkin lymphoma. Studies have found that TAK-007, which uses specially modified natural killer (NK) cells to target cancer, is generally safe, meaning most patients tolerate it well, even those with extensive prior treatments. In one study, TAK-007 achieved a 53.8% success rate in individuals with relapsed or hard-to-treat B-cell non-Hodgkin lymphoma. Of these, 30.8% experienced complete responses, with no detectable cancer after treatment.

Importantly, TAK-007 is well-tolerated, suggesting that many patients can manage the side effects. The treatment involves infusing patients with NK cells designed to attack cancer cells. These cells are derived from cord blood, facilitating large-scale production.

Overall, while TAK-007 remains under study, early results suggest it is safe for human use, particularly for those with challenging cancer cases. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about TAK-007 for treating Non-Hodgkin's Lymphoma because it uses a unique mechanism involving natural killer (NK) cells that are engineered with a chimeric antigen receptor (CAR) targeting the CD19 protein on cancer cells. Unlike traditional chemotherapy or antibody-based therapies, TAK-007 aims to harness the body's own immune system to more effectively identify and destroy cancer cells. This approach could potentially offer a more targeted attack on the cancer, reducing damage to healthy cells and possibly leading to fewer side effects. Additionally, TAK-007 is designed for a single-dose infusion, which might simplify treatment compared to more prolonged and complex regimens.

What evidence suggests that this trial's treatments could be effective for Non-Hodgkin's Lymphoma?

Research shows that TAK-007, which participants in this trial may receive, may help treat relapsed or refractory (r/r) B-cell non-Hodgkin lymphoma (NHL). In one study, TAK-007 achieved a 53.8% overall response rate, meaning just over half of the patients saw their cancer improve. Among these patients, 30.8% experienced a complete response, where the cancer was no longer detectable. The treatment uses CD19 CAR-NK cells, specially designed natural killer cells that target and destroy cancer cells. Early results suggest that TAK-007 is generally safe, making it a promising option for those with difficult cases of NHL. ^{1 2 3 5 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Dose Expansion: Cohort 2 (iNHL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Experimental Treatment 2 Interventions

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.

Group II: Dose Expansion: Cohort 1 (LBCL 3L+): TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Experimental Treatment 2 Interventions

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).

Group III: Dose Escalation: TAK-007 - 800×10^6 CD19-CAR+ Viable NK Cells Experimental Treatment 2 Interventions

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.

Group IV: Dose Escalation: TAK-007 - 200×10^6 CD19-CAR+ Viable NK Cells Experimental Treatment 2 Interventions

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.

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

Citations

1. immunitybio.com immunitybio.com/immunitybio-reports-complete-responses-in-non-hodgkin-waldenstrom-lymphoma-patients-with-chemotherapy-free-first-in-class-cd19-car-nk-immunotherapy/

CD19 CAR-NK is a targeted high- ... Single-agent CD19 CAR-NK cell therapy achieved a complete response in third-line Waldenstrom macroglobulinemia (WM), a type of non-Hodgkin ...

2. onclive.com onclive.com/view/tak-007-shows-favorable-safety-early-efficacy-data-in-r-r-b-cell-non-hodgkin-lymphoma

TAK-007 Shows Favorable Safety, Early Efficacy Data in R/ ... TAK-007 achieved a 53.8% overall response rate in relapsed/refractory B-cell non-Hodgkin lymphoma, with 30.8% complete responses and 23.1% ...

3. ash.confex.com ash.confex.com/ash/2024/webprogram/Paper194807.html

Efficacy and Safety of TAK-007, Cord Blood-Derived CD19 ... TAK-007, an allogeneic off-the-shelf CD19 CAR-NK cell therapy, demonstrated early efficacy at 800M and a favorable safety profile in a heavily ...

4. ajmc.com ajmc.com/view/two-patients-with-non-hodgkin-waldenstrom-lymphoma-see-complete-responses-with-cd19-car-nk-immunotherapy-immunitybio-reports

Two Patients With Non-Hodgkin Waldenstrom Lymphoma ... CD19 CAR NK cell therapy, alone or with rituximab, shows promise in relapsed/refractory B-cell NHL, including Waldenström macroglobulinemia.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11253502/

Harnessing natural killer cells for refractory/relapsed non ... This review aims to summarize clinical studies focusing on the applications of NK cells in the immunotherapy of patients with NHL.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04639739

Anti-CD19 CAR NK Cell Therapy for R/R Non-Hodgkin ... Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies.