NCT07297173 Phase 1 Study of Chemotherapy Plus HLA-mismatched GPBMC Infusion Bridging to Allo-HSCT for R/R Leukemia
| NCT ID | NCT07297173 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Beijing 302 Hospital |
| Condition | Relapsed Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2025-12-01 |
| Primary Completion | 2028-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 5 participants in total. It began in 2025-12-01 with a primary completion date of 2028-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a Phase 1 clinical study designed to evaluate the safety, tolerability, and preliminary efficacy of chemotherapy combining with HLA-mismatched G-CSF mobilized peripheral blood mononuclear cell (GPBMC) infusion as a bridging therapy to allogeneic hematopoietic stem cell transplantation (allo-HSCT) in patients with relapsed and refractory (R/R) leukemia.
Eligibility Criteria
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.
Contact & Investigator
Bo Cai, MD
PRINCIPAL INVESTIGATOR
Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital
Frequently Asked Questions
Who can join the NCT07297173 clinical trial?
This trial is open to participants of all sexes, aged 15 Years or older, studying Relapsed Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07297173 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07297173 currently recruiting?
Yes, NCT07297173 is actively recruiting participants. Contact the research team at caibo2008@163.com for enrollment information.
Where is the NCT07297173 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07297173 clinical trial?
NCT07297173 is sponsored by Beijing 302 Hospital. The principal investigator is Bo Cai, MD at Department of Hematology, the Fifth Medical Center of Chinese PLA General Hospital. The trial plans to enroll 5 participants.
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