Solid TumorsPhase 1/2NCT00900497
A Study Using White Blood Cells From Healthy Donors To Treat Solid Cancers
A Phase 1/2 study testing White Blood Cells/Granulocytes in people with Solid Tumors, run by Dipnarine Maharaj at 1 site in United States.
Trial summary
Background \& Rationale: About 75% of US population living today will not die of cancer. There has been a recent report of a colony of cancer-resistant mice developed from a single male mouse that unexpectedly survived challenges of lethal cancer cell injections. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solid Tumors
- What is being tested?
- White Blood Cells/Granulocytes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Dec 2030
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must have signed Subject Informed Consent form
- Documentation of Disease: All patients must have histologically or cytologically confirmed non-hematological malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Measurable Disease: Lesions that can be accurately measured in at least one dimension (longest diameter recorded) as ³20 mm with conventional technique or as ³10 mm with spiral CT scan.
- Life expectancy of at least 4 months as judged by the PI at the time of consent
- Performance status of ≤2 on the ECOG scale (see Appendix I).
- ≥ 4 weeks since prior medical therapy, radiation therapy, and surgery
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- Adequate organ function, such as absolute neutrophils ≥1,500/µl, platelet transfusion independent,
- platelet count ≥100,000/µl, serum bilirubin ≤2 mg/dl, AST/ALT less than 3x upper limit of normal and serum creatinine ≤2 mg/dl.
- Must have signed Donor-participant Informed Consent Form
- Must be a healthy, eligible blood donor who has completed Full-Length Universal Donor History Questionnaire version 1.2
- Must be able to donate granulocytes and be willing to undergo granulocyte apheresis
- Must have an HLA profile (A, B, DR) with results that ensure donated granulocytes will be mismatched with the recipient
- Must have CMV negative or positive sero-testing completed; only seronegative donors are accepted for a seronegative recipient
- Must have compatible ABO and RH typing with the subject
- Must be negative for HLA Class I \& II antibodies
Who cannot join
- Uncontrolled diabetes mellitus, significant cardiac disease, e.g. recent myocardial infarction ≥ within 30 days, or active serious infection.
- HIV infection and no recent use (within 30 days) of immunosuppressive agents other than steroids.
- Pregnant or nursing women.
- Men or Women of reproductive age who are not using an effective means of birth control.
- Women of childbearing potential who have a positive serum pregnancy test prior to treatment.
- HLA Class I \& II antibodies.
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- Neutrophil antibody test.
- Prior history of stem cell transplantation.
- Evidence of brain tumors or metastases.
- Prior history of fludarabine therapy.
- Positive Neutrophil antibody test
- Positive infectious disease workup within 30 days of apheresis / donation.
- Positive known cardiac illness that could cause a potential risk associated with leukapheresis.
- Genetic relationship to the recipient
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
South Florida Bone Marrow / Stem Cell Transplant Institute
Boynton Beach, Florida, 33437
About this study
Official title: A Phase I/II Study For the Use of White Blood Cells From Healthy Donor-participants To Treat Subjects With Solid Cancers
Background \& Rationale:
About 75% of US population living today will not die of cancer. There has been a recent report of a colony of cancer-resistant mice developed from a single male mouse that unexpectedly survived challenges of lethal cancer cell injections. In these so-called spontaneous regression/complete resistant (SR/CR) mice, cancer cells are killed by rapid infiltration of leukocytes, mainly of innate immunity. This highly effective natural cancer immunity is inherited and mediated entirely by white blood cells. Moreover, this cancer resistance can be transferred to wild type mice through the transfer of various immune cell types including granulocytes. The infusion of white blood cells, particularly cells of innate immunity, is a viable anticancer therapy in humans as well. 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 whether responses can be seen in cancer patients after infusion of HLA-mismatched white cells from healthy donors. It is important that the donors and recipients be unrelated and HLA-mismatched to avoid the possibility of transfusion-related Graft vs. Host Disease. The white blood cells from the healthy donors are being collected via apheresis following granulocyte mobilization with dexamethasone and filgrastim. The investigators will refer to the white blood cells as 'granulocytes' because 75-90% of the white blood cells collected through the apheresis will consist of granulocytes. The dose of at least 2x10 to the11th will be given from 4-5 donors at a rate of no more than one donor per day for each recipient. There will only be one infusion per day and no more than 5 infusions per week. Thus, a typical treatment in the study would span 1-2 weeks. After each infusion, the patients will be monitored carefully for possible adverse events. If adverse events occur at any time point during or after individual infusion, the treatment can be stopped until the adverse events can be managed. The daily dose of each infusion is a frequently used level that has a long safety record. The trial will observe the subject's cancer for 3 months after the granulocyte infusions are completed. Response at 90 days will be based on comparison of tumor measurements at baseline. The trial has 3 major endpoints: dose response and tolerance, safety, and efficacy.
Read the detailed description
Up to 29 Subjects with metastatic, non-hematological cancer can be entered. Potentially hundreds of healthy Donor-participants will be recruited. A Donor Registry will be built to store ABO/Rh-specific donors; these donors will be tested for HLA-specific genotyping as well as fully tested for infectious diseases.
Each patient will be receiving granulocytes from approximately 4 to 6 donors. Each donor will be HLA-mismatched to avoid engraftment of the granulocytes and any transfusion-related GVHD. These infusions will take place over a 1 to 2 week period, the timing of which will be dependent on both the subject's tolerance and the availability of the donors.
Subject Response Assessment:
For all patients not demonstrating disease progression, response status will be evaluated between Days +90 to +100 after the last infusion. Day+1 is the first day of white cell infusion. All measurable lesions (lesions that can be accurately measured in at least one dimension [longest diameter to be recorded] as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan) up to a maximum of 10 lesions representative of all involved organs should be identified as target lesions and will be recorded and measured at baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repetitive measurements (either by imaging techniques or clinically). A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease. The criteria for response, progression, and relapse are as follows.
- Complete Response: Disappearance of all target lesions.
- Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
- Progression (PD): At least a 20% increase in the sum of the LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started. Patients having a documented response with no reconfirmation of the response will be listed with stable disease.
- Conditions
- Solid Tumors
- Being tested
- White Blood Cells/Granulocytes
- Keywords
- granulocytes, Graft-vs-Host-Disease
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
White Blood Cells/GranulocytesBiological
Granulocytes collected by apheresis, cross-matched for ABO-Rh and common antibodies, HLA-mismatched to avoid engraftment
| Study group | Role | What they receive |
|---|---|---|
| White Blood Cells/Granulocytes | Experimental | Fresh, non-irradiated granulocytes from ABO-Rh compatible, HLA-mismatched donors Receives: Biological: White Blood Cells/Granulocytes |
What is being measured
The primary outcome is the main question the study is designed to answer.
The trial will observe the subject's cancer status for 3 months after the granulocyte infusions are completed. Response at 90 days will be based on comparison of tumor measurements at baseline.
Measured: 90 to 100 days post treatment
Secondary outcomes (1)
The trial will evaluate the safety and dose tolerance of the transfusion of non-irradiated granulocytes (approximately 4 to 6 donors to reach a level of 2 x 10 to the 11th cells) from HLA-mismatched donors
Measured: 1 to 2 weeks treatment and 30 days post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2029 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dipnarine Maharaj
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dipnarine Maharaj, South Florida Bone Marrow/Stem Cell Transplant Institute
- Investigators
- Dipnarine Maharaj, MD, Principal investigator, Medical Director, South Florida Bone Marrow / Stem Cell Transplant Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00900497
- Sponsor's protocol ID
- 08001-BMSCTI
- Status last verified
- Apr 2026
- First submitted
- 11 May 2009
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Study For the Use of White Blood Cells From Healthy Donor-participants To Treat Subjects With Solid Cancers
- ClinicalTrials.gov ID
- NCT00900497
- Acronym / sponsor ID
- 08001-BMSCTI
- Conditions
- Solid Tumors
- Keywords
- granulocytes, Graft-vs-Host-Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Dipnarine MaharajUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background \& Rationale:
About 75% of US population living today will not die of cancer. There has been a recent report of a colony of cancer-resistant mice developed from a single male mouse that unexpectedly survived challenges of lethal cancer cell injections. In these so-called spontaneous regression/complete resistant (SR/CR) mice, cancer cells are killed by rapid infiltration of leukocytes, mainly of innate immunity. This highly effective natural cancer immunity is inherited and mediated entirely by white blood cells. Moreover, this cancer resistance can be transferred to wild type mice through the transfer of various immune cell types including granulocytes. The infusion of white blood cells, particularly cells of innate immunity, is a viable anticancer therapy in humans as well. 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 whether responses can be seen in cancer patients after infusion of HLA-mismatched white cells from healthy donors. It is important that the donors and recipients be unrelated and HLA-mismatched to avoid the possibility of transfusion-related Graft vs. Host Disease. The white blood cells from the healthy donors are being collected via apheresis following granulocyte mobilization with dexamethasone and filgrastim. The investigators will refer to the white blood cells as 'granulocytes' because 75-90% of the white blood cells collected through the apheresis will consist of granulocytes. The dose of at least 2x10 to the11th will be given from 4-5 donors at a rate of no more than one donor per day for each recipient. There will only be one infusion per day and no more than 5 infusions per week. Thus, a typical treatment in the study would span 1-2 weeks. After each infusion, the patients will be monitored carefully for possible adverse events. If adverse events occur at any time point during or after individual infusion, the treatment can be stopped until the adverse events can be managed. The daily dose of each infusion is a frequently used level that has a long safety record. The trial will observe the subject's cancer for 3 months after the granulocyte infusions are completed. Response at 90 days will be based on comparison of tumor measurements at baseline. The trial has 3 major endpoints: dose response and tolerance, safety, and efficacy.
Detailed description
Up to 29 Subjects with metastatic, non-hematological cancer can be entered. Potentially hundreds of healthy Donor-participants will be recruited. A Donor Registry will be built to store ABO/Rh-specific donors; these donors will be tested for HLA-specific genotyping as well as fully tested for infectious diseases.
Each patient will be receiving granulocytes from approximately 4 to 6 donors. Each donor will be HLA-mismatched to avoid engraftment of the granulocytes and any transfusion-related GVHD. These infusions will take place over a 1 to 2 week period, the timing of which will be dependent on both the subject's tolerance and the availability of the donors.
Subject Response Assessment:
For all patients not demonstrating disease progression, response status will be evaluated between Days +90 to +100 after the last infusion. Day+1 is the first day of white cell infusion. All measurable lesions (lesions that can be accurately measured in at least one dimension [longest diameter to be recorded] as ≥20 mm with conventional techniques or as ≥10 mm with spiral CT scan) up to a maximum of 10 lesions representative of all involved organs should be identified as target lesions and will be recorded and measured at baseline. Target lesions should be selected on the basis of their size (lesions with the longest diameter) and their suitability for accurate repetitive measurements (either by imaging techniques or clinically). A sum of the longest diameter (LD) for all target lesions will be calculated and reported as the baseline sum LD. The baseline sum LD will be used as reference to further characterize the objective tumor response of the measurable dimension of the disease. The criteria for response, progression, and relapse are as follows.
- Complete Response: Disappearance of all target lesions.
- Partial Response (PR): At least a 30% decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
- Progression (PD): At least a 20% increase in the sum of the LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions.
- Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started. Patients having a documented response with no reconfirmation of the response will be listed with stable disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| White Blood Cells/Granulocytes | Experimental | Biological: White Blood Cells/GranulocytesFresh, non-irradiated granulocytes from ABO-Rh compatible, HLA-mismatched donors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Must have signed Subject Informed Consent form
- Documentation of Disease: All patients must have histologically or cytologically confirmed non-hematological malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
- Measurable Disease: Lesions that can be accurately measured in at least one dimension (longest diameter recorded) as ³20 mm with conventional technique or as ³10 mm with spiral CT scan.
- Life expectancy of at least 4 months as judged by the PI at the time of consent
- Performance status of ≤2 on the ECOG scale (see Appendix I).
Key exclusion criteria (14 listed)
- Uncontrolled diabetes mellitus, significant cardiac disease, e.g. recent myocardial infarction ≥ within 30 days, or active serious infection.
- HIV infection and no recent use (within 30 days) of immunosuppressive agents other than steroids.
- Pregnant or nursing women.
- Men or Women of reproductive age who are not using an effective means of birth control.
- Women of childbearing potential who have a positive serum pregnancy test prior to treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| White Blood Cells/GranulocytesGranulocytes collected by apheresis, cross-matched for ABO-Rh and common antibodies, HLA-mismatched to avoid engraftment | Biological | White Blood Cells/Granulocytes |
Primary outcome
The trial will observe the subject's cancer status for 3 months after the granulocyte infusions are completed. Response at 90 days will be based on comparison of tumor measurements at baseline.
Time frame: 90 to 100 days post treatment
1 secondary outcome
The trial will evaluate the safety and dose tolerance of the transfusion of non-irradiated granulocytes (approximately 4 to 6 donors to reach a level of 2 x 10 to the 11th cells) from HLA-mismatched donors
Time frame: 1 to 2 weeks treatment and 30 days post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
Related trials for Solid Tumors
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A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
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A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
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IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
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Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dipnarine Maharaj, MD principal investigator
Medical Director, South Florida Bone Marrow / Stem Cell Transplant Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing White Blood Cells/Granulocytes in people with Solid Tumors, run by Dipnarine Maharaj at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The trial will observe the subject's cancer status for 3 months after the granulocyte infusions are completed. Response at 90 days will be based on comparison of tumor measurements at baseline. (time frame: 90 to 100 days post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.