White Blood Cell Infusions for Solid Cancers

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Dipnarine Maharaj

Must not be taking: Immunosuppressants

Disqualifiers: Diabetes, Cardiac disease, HIV, others

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

Compensation: Varies

Number of Visits: 5

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether infusions of white blood cells from healthy donors can help treat solid cancers that are widespread or inoperable. The treatment uses granulocytes, a type of white blood cell, to enhance the body's natural defense against cancer. Participants must have a confirmed solid cancer that hasn't responded to standard treatments and a life expectancy of at least four months. The trial will assess the treatment's tolerance, safety, and effectiveness in shrinking tumors over three months. 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 new treatment.

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

The trial protocol does not specify whether you need to stop taking your current medications. However, you must have completed any prior medical therapy, radiation therapy, or surgery at least 4 weeks before joining the trial.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that giving white blood cells from healthy donors to patients might be a promising cancer treatment. These cells, mainly granulocytes, are collected safely and have been used in similar amounts many times before, establishing a good safety record for this treatment.

Past experiences suggest that these infusions are generally well-tolerated. Patients receive close monitoring for any side effects, and the treatment can be paused if needed to manage any issues. The daily dose used in this treatment has been safely administered in other situations, providing reassurance about its safety.

While this specific trial is still assessing safety, previous use of granulocytes in the planned doses has been safe. This helps clarify the potential safety of this treatment. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for solid cancers, which often involve chemotherapy or radiation, this new approach uses fresh granulocytes, a type of white blood cell, from donors. Researchers are excited about this treatment because it offers a novel way to boost the immune system directly against cancer cells. The unique mechanism of action involves using granulocytes to potentially enhance the body's natural cancer-fighting abilities, providing a promising alternative that might reduce reliance on more aggressive treatments.

What evidence suggests that white blood cell infusions might be an effective treatment for solid cancers?

Research has shown that using certain white blood cells, called granulocytes, from healthy donors might effectively treat cancer. In animal studies, infusions of these cells greatly improved survival rates and increased the chance of shrinking tumors from 17% to 75%. This trial will investigate the use of granulocytes, which could help the body fight cancer. The idea originates from studies on special cancer-resistant mice, where these white blood cells played a crucial role in eliminating cancer. These findings suggest that infusing white blood cells could be a promising new cancer treatment. ^{1 4 6 7 8}

Who Is on the Research Team?

Dipnarine Maharaj, MD

Principal Investigator

Medical Director, South Florida Bone Marrow / Stem Cell Transplant Institute

Are You a Good Fit for This Trial?

This trial is for people with solid tumors that are metastatic or unresectable, where standard treatments have failed. Participants must be able to donate white blood cells (granulocytes), have a specific HLA mismatch with the donor, and meet certain health criteria like good organ function and performance status. Pregnant women, those with brain tumors or recent serious illnesses, and individuals on recent immunosuppressants cannot join.

Inclusion Criteria

My cancer is confirmed by tests, cannot be surgically removed, and has spread.

Lesions must be measurable as specified

It has been over 4 weeks since my last medical treatment, radiation, or surgery.

Exclusion Criteria

I do not have uncontrolled diabetes, serious heart conditions, or active infections.

I am of reproductive age and not using effective birth control.

I have been tested for HLA Class I & II antibodies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive granulocyte infusions from healthy donors over a period of 1-2 weeks

1-2 weeks

Up to 5 infusions per week, one infusion per day

Follow-up

Participants are monitored for safety and effectiveness after treatment, with response assessment between Days +90 to +100

3 months

What Are the Treatments Tested in This Trial?

Interventions

• White Blood Cells/Granulocytes

Trial Overview The study tests if infusing granulocytes from healthy donors can treat cancer. Patients will receive these white blood cells through a process called apheresis after the donors take medications to increase cell production. The treatment spans 1-2 weeks with daily monitoring for side effects, assessing dose response, safety, and effectiveness over three months.

How Is the Trial Designed?

Group I: White Blood Cells/Granulocytes Experimental Treatment 1 Intervention

Fresh, non-irradiated granulocytes from ABO-Rh compatible, HLA-mismatched donors

Who Is Running the Clinical Trial?

Dipnarine Maharaj

Lead Sponsor

Trials

2

Recruited

60+

Published Research Related to This Trial

The study involved 40 elderly patients with acute myeloid leukemia (AML), showing that donor NK cell infusions are generally safe, with only mild side effects like moderate fever occurring in a few cases after multiple infusions.

High-purity NK cells were successfully expanded and transfused, with no cases of acute graft-versus-host disease (GVHD) observed in elderly AML patients, indicating a promising safety profile for this treatment approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical Safety of NK Cell in the Prevention of Leukemia Relapse Post-transplantation and in Treatment of the Elderly Leukemia Patients]. Liu, J., Zheng, XL., Xue, M., et al.[2022]

In a study involving 31 patients with acute myeloid leukemia and high-risk lymphoma, repeated infusions of cord blood-derived NK (CB-NK) cells after autologous stem cell transplantation (ASCT) showed promising safety, with only mild infusion reactions occurring in 15.5% of cases.

Patients receiving CB-NK cell therapy had significantly better progression-free survival (PFS) and overall survival (OS) rates compared to a control group, suggesting that this maintenance therapy could effectively reduce relapse rates and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot study of cord blood-derived natural killer cells as maintenance therapy after autologous hematopoietic stem cell transplantation. Wu, Y., Wang, Y., Ji, J., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10717563/

Prognostic value of circulating tumor cells associated with ... The pooled analysis demonstrated that the presence of CTC-WBC clusters was significantly associated with worse OS (HR = 2.44, 95% CI: 1.74–3.40, P < 0.001) and ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT00900497

A Study Using White Blood Cells From Healthy Donors To ... This proposed trial will test whether white blood cell infusions from healthy unrelated donors can be used to treat cancer.

3. mdanderson.org mdanderson.org/newsroom/research-newsroom/researchers-find-new-biomarker-for-improved-immunotherapy-response-in-solid-tumors.h00-159780390.html

Researchers find new biomarker for improved ... Researchers find new biomarker for improved immunotherapy response in solid tumors. MD Anderson Research News October 16, 2025. Study uncovers ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38087278/

Prognostic value of circulating tumor cells associated with ... Conclusions: CTC-WBC clusters are negative predictors for OS and PFS/DFS/MFS/RFS in patients with solid tumors. Monitoring CTC-WBC levels may ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0171298510000033

Granulocytes as effective anticancer agent in experimental ... The administration of granulocytes significantly improved the survival of W256-bearing rats, and increased the tumor regression incidence from 17% up to 75%.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT00900497

A Study Using White Blood Cells From Healthy Donors To ... This proposed trial will test whether white blood cell infusions from healthy unrelated donors can be used to treat cancer. The trial is designed to determine ...

7. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cam4.6645

Baseline blood cell counts correlate with survival after ... Real-world outcomes of 18,186 metastatic solid tumor outpatients: Baseline blood cell counts correlate with survival after immune checkpoint ...

8. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-023-11711-7

Prognostic value of circulating tumor cells associated with ... CTC-WBC clusters are negative predictors for OS and PFS/DFS/MFS/RFS in patients with solid tumors. Monitoring CTC-WBC levels may provide valuable information.