ThINKK Immunotherapy for Cancer

(ThINKK-01 Trial)

Not yet recruiting at 1 trial location
MD
KL
Overseen ByKarine Leveille
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new immunotherapy treatment called ThINKK, designed to boost the body's natural killer cells after a stem cell transplant to help prevent cancer relapse. The treatment enhances the immune response by stimulating these cells, which often lack the necessary activation when fighting cancer. It may suit children diagnosed with acute leukemia or neuroblastoma who have recently undergone a stem cell transplant and have sufficient natural killer cell counts. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this innovative therapy.

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

The trial requires that you stop taking systemic corticosteroids above a certain dose and cyclosporine. If you are tapering off corticosteroids, you may join once your dose is low enough, with approval. Other prohibited treatments are listed in a specific section not provided here.

Is there any evidence suggesting that ThINKK immunotherapy is likely to be safe for humans?

Research has shown that ThINKK immunotherapy is expected to be safe for patients who have undergone stem cell transplants. Studies suggest it does not increase the risk of graft-versus-host disease (GvHD), a common concern after these transplants. However, nearly all patients in similar treatments have experienced some side effects, with about half facing serious ones. This is typical in early-stage trials where researchers closely monitor safety. Participants should be aware of these possibilities but also know that ongoing studies aim to enhance the treatment's safety.12345

Why do researchers think this study treatment might be promising?

ThINKK is unique because it represents a new frontier in immunotherapy for cancer treatment. Unlike traditional chemotherapy and radiation, which target cancer cells directly but can also harm healthy cells, ThINKK works by harnessing the body's immune system to identify and attack cancer cells more precisely. This approach not only promises fewer side effects but also has the potential for longer-lasting results by training the immune system to recognize and fight cancer cells even after the treatment ends. Researchers are excited about ThINKK because it could offer a more targeted and sustainable solution for cancer patients, potentially transforming how we approach cancer treatment.

What evidence suggests that ThINKK might be an effective treatment for cancer?

Research has shown that ThINKK immunotherapy appears promising in early studies. It boosts the activity of natural killer (NK) cells, which play a crucial role in fighting cancer. In early tests on mice, ThINKK controlled the growth of acute lymphoblastic leukemia. This finding suggests it might help prevent cancer recurrence in people after stem cell transplants. The therapy mimics natural signals that guide NK cells to locate and attack cancer cells. Initial results suggest it could be safe and effective for patients.56789

Who Is on the Research Team?

MD

Michel Duval, MD

Principal Investigator

St. Justine's Hospital

SH

Sabine Herblot, PhD

Principal Investigator

St. Justine's Hospital

Are You a Good Fit for This Trial?

This trial is for children aged 2 to under 13 who have had a stem cell transplant for acute leukemia or neuroblastoma within the past 30–90 days, have enough natural killer cells in their blood, and are expected to live at least three more months. Children with severe infections, uncontrolled symptoms, recent cancer relapse, or certain health issues cannot join.

Inclusion Criteria

I have been diagnosed with acute leukemia or neuroblastoma.
I had a donor stem cell transplant 30 to 90 days ago.
Blood NK cell counts ≥ 100 x 10E+6 cells/L at least once before eligibility confirmation
See 3 more

Exclusion Criteria

O2 Sat saturation <90% on room air by pulse oximetry
I have had life-threatening diarrhea needing urgent medical care.
I do not have any uncontrolled, life-threatening infections.
See 12 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ThINKK adoptive immunotherapy after allogeneic HSCT

Duration not specified

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • ThINKK

Trial Overview

The study tests ThINKK immunotherapy—a treatment designed to boost the body's natural killer (NK) cells—after a bone marrow (stem cell) transplant in kids with leukemia or neuroblastoma. The goal is to see if this new therapy can help prevent cancer from coming back.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: TreatmentExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Michel Duval

Lead Sponsor

Héma-Québec

Collaborator

Trials
2
Recruited
1,800+

ExCellThera inc.

Industry Sponsor

Trials
5
Recruited
90+

Centre C3i

Collaborator

Trials
1
Recruited
20+

Citations

Therapeutic Inducers of Natural Killer cell Killing (ThINKK)

Our results indicate that ThINKK immunotherapy is expected to be safe and effective in transplanted patients, even in allogeneic settings.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38754915/

Therapeutic Inducers of Natural Killer cell Killing (ThINKK)

We previously demonstrated that ThINKK stimulate NK cells and control acute lymphoblastic leukemia (ALL) development in a preclinical mouse model of HSCT for ...

Immunotherapy Improves Results in Head and Neck Cancer

People who received immunotherapy had an event-free survival of 51.8 months, compared with 30.4 months for those who did not receive ...

Immunotherapy: Precision Medicine in Action

Immunotherapy has shown success in 15 different types of cancers including lung cancer, head and neck cancer, bladder cancer, kidney cancer, and Hodgkin ...

The Effectiveness of Cancer Immune Checkpoint Inhibitor ...

Despite promising results, it turned out that ICIs are effective only in up to 20% of cancer patients [10,11]. Also, the effect is highly ...

ThINKK Immunotherapy for Cancer · Info for Participants

The ThINKK-01 medical study, being run by Michel Duval, needs participants to evaluate whether ThINKK will have tolerable side effects ...

Cancer Immunotherapy–Related Adverse Effects Prompt ...

The study showed that any-cause adverse events occurred in 96.6% of patients, and grade 3–5 adverse events occurred in 50.6% of patients.

NCT06249048 | Phase 1/2 Study of Intratumoral Injection ...

Phase 1/2, Open-label, Multi-center, First-in-human Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of STX-001 ...

Therapeutic Inducers of Natural Killer cell Killing (ThINKK)

Our results indicate that ThINKK immunotherapy is expected to be safe and effective in transplanted patients, even in allogeneic settings.