CD5 CAR NK Cells for Blood Cancers

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Steroids, Immunosuppressants, Anticancer agents

Disqualifiers: Infections, Hepatitis, HIV, Autoimmune, 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: Unknown

Duration: 4-6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines a new treatment for individuals in remission from aggressive T-cell blood cancers, such as certain types of leukemia and lymphoma. The researchers aim to determine if using special immune cells, known as NK cells (specifically iC9/CD5CAR/IL-15 NK cells), along with medications like Rituximab, can safely prevent cancer recurrence. Participants must have blood cancers where at least 30% of the cancer cells display a marker called CD5 and must be in their first remission. As a Phase 2 trial, it focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, like systemic steroids and immunosuppressive therapy, before participating. You may continue targeted therapies until at least three days before starting the trial's chemotherapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that a new treatment using special cells called iC9/CD5CAR/IL-15 NK cells is being tested for safety and effectiveness in treating aggressive T-cell blood cancers. Some studies have found that these engineered cells can successfully target cancer cells. However, more testing is needed to fully understand their safety.

In earlier research, patients with relapsed or hard-to-treat T-cell cancers generally tolerated these cells well, meaning most did not experience severe side effects. While some studies suggest these treatments are promising, they are still being tested to ensure safety for everyone.

Since this is a Phase 2 trial, the treatment has demonstrated some safety in earlier phases and is now being tested in more people to confirm it. Joining this trial contributes to understanding the safety and effectiveness of these NK cells. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the use of CD5 CAR NK cells for blood cancers because these cells offer a novel approach by harnessing the body's own immune system. Unlike traditional treatments like chemotherapy or monoclonal antibodies, CD5 CAR NK cells are engineered to specifically recognize and attack cancer cells, potentially leading to more effective targeting with fewer side effects. Additionally, these cells are enhanced with interleukin-15 (IL-15), which helps them survive longer and remain active in the body, boosting their cancer-fighting potential. This innovative approach could offer a promising alternative to current therapies, which often involve broader and more aggressive methods.

What evidence suggests that this trial's treatments could be effective for blood cancers?

Studies have shown that CAR-NK cell therapies hold promise for treating blood cancers. Research indicates that these specially engineered cells can effectively find and destroy cancer cells. In this trial, participants will receive iC9/CD5CAR/IL-15 NK cells, designed to target T-cell blood cancers. Previous patients responded well to similar CAR-NK cell treatments, leading to better health outcomes. These therapies may help prevent cancer from worsening for at least a year. Overall, these findings suggest that iC9/CD5CAR/IL-15 NK cells could effectively treat aggressive T-cell blood cancers. ^{1 3 6 7 8}

Who Is on the Research Team?

Chitra Hosing, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients in first remission from aggressive T-cell blood cancers. Participants must meet specific health criteria not detailed here.

Inclusion Criteria

Patients must meet disease-specific eligibility criteria

Ability to understand and sign a written informed consent document

Signed consent to long-term follow-up protocol PA17-0483

Exclusion Criteria

Concomitant use of other investigational agents

I am not using other cancer treatments.

I am currently experiencing symptoms of GVHD.

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 as part of the treatment regimen

2 weeks

Treatment

Participants receive Rituximab and iC9/CD5CAR/IL-15 NK Cells

4-6 weeks

Inpatient/outpatient visits at PI's discretion

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Cyclophosphamide
• Fludarabine
• iC9/CD5CAR/IL-15 NK cells

Trial Overview The study tests if engineered NK cells combined with chemo can help keep cancer at bay for a year without it getting worse. It's a Phase II trial, which means they're looking at how safe the treatment is and how well it works.

How Is the Trial Designed?

Group I: Cohort 1 and Cohort 2: Treatment with Rituximab + iC9/CD5CAR/IL-15 NK Cells Experimental Treatment 4 Interventions

Participants will recived treatment on an inpatient/outpatient basis at PI's discretion

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05110742

NCT05110742 | Phase I/II Study of CD5 CAR Engineered ... Primary objective: To determine the safety, tolerability and optimal cell dose of iC9/CD5CAR/IL-15 NK cells in patients with relapsed/refractory T-cell ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11239349/

Advances in CAR-NK cell therapy for hematological ... CAR-T cell therapy has revolutionized the treatment of hematological malignancies, demonstrably improving patient outcomes and prognosis.

3. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2021-10898

iC9 CD5 CAR Engineered IL15-Transduced Cord Blood- ... Giving lymphodepleting chemotherapy before iC9/CD5CAR/IL-15 NK cells helps kill cancer cells in the body and helps make room in the patient's bone marrow for ...

4. withpower.com withpower.com/trial/phase-2-hematologic-neoplasms-1-2026-3402c

CD5 CAR NK Cells for Blood Cancers · Info for Participants Trial Overview The study tests if engineered NK cells combined with chemo can help keep cancer at bay for a year without it getting worse.

5. ehoonline.biomedcentral.com ehoonline.biomedcentral.com/articles/10.1186/s40164-023-00431-0

Chimeric antigen receptor engineered natural killer cells ... To date, CAR-NK cells have shown impressive efficacy in the treatment of hematological tumors and have been widely studied in the treatment of ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11980226/

Engineering CD5-targeting CAR-NK cells from peripheral ... This study developed a controllable CD5 CAR-NK cells that exhibit high efficacy against T-cell malignancies, although further validation is necessary to assess ...

7. nature.com nature.com/articles/s41591-023-02785-8

Safety, efficacy and determinants of response of allogeneic ... Cord blood NK cells engineered to express IL-15 and a CD19-targeted CAR show long-term persistence and potent antitumor activity. Leukemia ...

8. frontiersin.org frontiersin.org/journals/immunology/articles/10.3389/fimmu.2024.1414264/full

Advances in CAR-NK cell therapy for hematological ... Preclinical studies have yielded promising preliminary data on the efficacy and safety of CAR-NK cell therapy, especially in the context of hematological ...