Experimental combo aims to help leukemia patients reach transplant
NCT ID NCT07297173
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase study tests whether giving chemotherapy followed by an infusion of immune cells from a partially matched donor can help patients with relapsed or refractory leukemia get to a stem cell transplant. Only 5 participants will be enrolled to check safety and side effects like graft-versus-host disease and infections. The goal is to find a better way to control the disease long enough for a transplant to work.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HLA-mismatched G-CSF mobilized peripheral blood mononuclear cells (donor immune cells)
- What this could lead to
- If successful, this approach could help more patients with hard-to-treat leukemia get to a stem cell transplant and possibly achieve long-term disease control.
- What could go wrong
- This is a very early Phase 1 trial with only 5 people, so safety and effectiveness are not yet known. There are serious risks like graft-versus-host disease and severe infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
About 5 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2025
- Expected to finish
-
Dec 2030
An estimate. End dates often move.
- Lead sponsor
-
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
-
15 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * Age \>=15 years, male or female, non-limited by race or ethnicity. * Confirmed diagnosis of R/R leukemia and risk stratification according to the World Health Organization (WHO) 5th edition classification, based on histopathology and cytogenetics. * Adequate hepatic function including alanine transaminase (ALT) and aspartate aminotransferase (AST )\<= 3 × upper limit of normal(ULN), and total bilirubin \<= 1.5 × ULN. * Adequate renal function including serum creatinine \<= 2 × ULN or CrCl\>= 40mL/min. * LVEF measured by echocardiogram is within the normal range (LVEF \> 50%). * The subject must have one HLA mismatched donor who is \>= 18 years old to provide GPBMCs for the first-step infusion. If this donor is not qualified as an allo-HSCT donor, the subject must also have another donor who is \>= 18 years old and qualified as allo-HSCT donor (i.e., matched sibling, 9-10/10 loci matched unrelated, or haploidentical). In addition, the donor voluntarily donates hematopoietic stem cells and signs the consent form. Each subject (or his/her legal representatives) must sign the Informed Consent Form (ICF), indicating that he/she understands the purpose and procedures of research, and is willing to participate in research. * Donor inclusion criteria: The donor meets the institution's criteria for related peripheral blood hematopoietic stem cell donors. The donor must be able to tolerate the cell separation and collection process, and sign the Informed Consent Form. Exclusion Criteria: * Uncontrolled infection or hemorrhage. * Cardiovascular disease with clinical significance, such as uncontrolled or highly symptomatic cardiac arrhythmias, congestive heart failure, or myocardial infarction within 6 months prior to screening, or New York Heart Association (NYHA) function class 3 (moderate) or class 4 (severe) heart disease. * Uncontrolled autoimmune disease or requiring immunosuppression treatment. * History of severe blood infusion reaction. * Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception. * Psychiatric disorder or cognitive impairment that in the researcher's judgment would make the subject not likely to adhere to the protocol requirements. * Major surgery within 4 weeks prior to enrollment. * Life-threatening illness other than leukemia or uncontrolled intercurrent illness.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Refractory leukemia are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital
RECRUITINGBeijing, 100071, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a new drug duo outsmart a tough childhood leukemia?
- Engineered immune cells take aim at Hard-to-Treat leukemias
- Italian study tracks how venetoclax works for CLL patients in everyday practice
- New Triple-Drug attack on tough leukemia enters human testing
- New Three-Drug cocktail aims to outsmart tough leukemia
- New drug duo targets hard-to-treat leukemias in early trial