Radioactive antibody hones in on cancer cells to boost transplant success
NCT ID NCT05139004
First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time
Summary
This trial tests whether adding a radioactive antibody (90Y-DOTA-anti-CD25 basiliximab) to standard chemotherapy and targeted radiation can better prepare the bone marrow for a stem cell transplant in people with high-risk acute leukemia or myelodysplastic syndrome. The antibody seeks out and destroys cancer cells carrying the CD25 marker, while the chemo and radiation clear space for donor cells. The goal is to find the safest dose and see if this combination improves transplant outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 90Y-DOTA-anti-CD25 basiliximab (radioactive antibody)
- What this could lead to
- If it works, this approach could improve the success of stem cell transplants for people with hard-to-treat leukemia or MDS.
- What could go wrong
- This is an early-phase trial with only 7 participants, so the dose and safety are still being figured out. Radioactive and chemotherapy drugs can cause serious side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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7 people
The number who actually took part.
- Started
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Jul 2022
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Assent, when appropriate, will be obtained per institutional guidelines * Age: \>= 60 years. Note: Patients \>= 18 years and \< 60 years are also included if they are not candidates for myeloablative conditioning regimens due to comorbidities * Karnofsky performance status \>= 70 * Eligible patients will have a histopathological confirmed diagnosis of hematologic malignancy in one of the following categories which express CD25 as determined by immunohistochemistry: * Acute myelogenous leukemia: * Patients with de novo or secondary disease in unfavorable risk group including poor risk cytogenetics according to National Comprehensive Cancer Network (NCCN) guidelines for acute myeloid leukemia (AML) i.e., monosomal karyotype, -5,5q-,-7,7q-, 11q23-non t(9;11), inv (3), t(3;3), t(6;9), t(9;22) and complex karyotypes (\>= 3 unrelated abnormalities), or all patient in intermediate risk groups accept patients with FLT3-NPM1+ disease * Patients with a complete morphological remission (CR) with minimal residual disease (MRD)-positive status by flow cytometry or cytogenetic * Patients with chemosensitive active disease * Acute lymphocytic leukemia: * Patients with de novo or secondary disease according to NCCN guidelines for acute lymphocytic leukemia (ALL) hypoploidy (\< 44 chromosomes); t(v;11q23): MLL rearranged; t(9;22) (q34;q11.2); complex cytogenetics (5 or more chromosomal abnormalities); high white blood cell (WBC) at diagnosis (\>= 30,000 for B lineage or \>=50,000 for T lineage); iAMP21loss of 13q, and abnormal 17p * Patients with a complete morphological remission (CR) with MRD-positive status by flow cytometry or cytogenetics * Patients with chemosensitive active disease * Myelodysplastic syndrome in high-intermediate (int-2) and high-risk categories * A pretreatment measured creatinine clearance (absolute value) of \>= 60 ml/minute (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated) * Patients must have a serum bilirubin =\< 2.0 mg/dl (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated) * Serum glutamic-oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) =\< 2.5 times the institutional upper limits of normal (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated) * Ejection fraction measured by echocardiogram or multigated acquisition scan (MUGA) \>= 50% (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated) * Diffusion capacity of the lung for carbon monoxide (DLCO) and forced expiratory volume in 1 second (FEV1) \> 50% predicted (performed within 30 days prior to day 1 of protocol therapy unless otherwise stated) * Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months after the last dose of protocol therapy * Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for \> 1 year (women only) Exclusion Criteria: * Autologous or allogeneic hematopoietic cell transplant * Patients may not have received more than 3 prior regimens, where the regimen intent was to induce remission * Receiving any other investigational agents or concurrent biological, intensive chemotherapy or radiation therapy for the previous 2 weeks from conditioning. Note: Receiving any other investigational agents or concurrent biological, intensive chemotherapy or radiation therapy for the previous 2 weeks from conditioning * Patients should have discontinued all previous intensive therapy, chemotherapy, or radiotherapy for 2 weeks prior to commencing therapy on this study. Note: Low dose chemotherapy or maintenance chemotherapy given within 7 days of planned study enrollment is permitted. These include hydroxyurea, 6-meraptopurine, oral methotrexate, vincristine, oral etoposide, and tyrosine kinase inhibitors (TKIs). FLT-3 inhibitors can also be given up to 3 days before conditioning regimen * All patients with prior radiation treatment to the lung, liver, and kidney will be excluded. For other scenarios of prior radiation treatment, up to 2000 cGy at 2 Gy per day will be allowed. Inclusion of patients with previous radiation exposure will be determined based on the radiation oncologist medical doctor (MD) evaluation and judgment * History of allergic reactions attributed to compounds of similar chemical or biologic composition to study agent * Patients with other active malignancies are ineligible for this study, other than non-melanoma skin cancers * Patients should not have any uncontrolled illness including ongoing or active bacterial, viral or fungal infection * The recipient has a medical problem or neurologic/psychiatric dysfunction which would impair his/her ability to be compliant with the medical regimen and to tolerate transplantation or would prolong hematologic recovery which in the opinion of the principal investigator would place the recipient at unacceptable risk * Females only: Pregnant or breastfeeding * Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures * Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics) * DONOR: Evidence of active infection * DONOR: Medical or physical reason which makes the donor unlikely to tolerate or cooperate with growth factor therapy and leukapheresis * DONOR: Factors which place the donor at increased risk for complications from leukapheresis or granulocyte-colony stimulating factor (G-CSF) therapy could be harvested for bone marrow (BM) if safer for the donor and if approved by principal investigator (PI) * DONOR: Human immunodeficiency virus (HIV) positive
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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City of Hope Medical Center
Duarte, California, 91010, United States
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