NCT06681922 A Phase I-II Study of High-Dose Post-Transplant Cyclophosphamide, Bortezomib, and Abatacept for the Prevention of Graft-Versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)
| NCT ID | NCT06681922 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Northwell Health |
| Condition | Graft Vs Host Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2024-09-23 |
| Primary Completion | 2027-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
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 10 participants in total. It began in 2024-09-23 with a primary completion date of 2027-10.
⚠ 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
The study will be conducted in two phases. The phase I portion will employ a 3+3 dose-escalation design to define the maximum tolerated dose (MTD) of abatacept added to PTCy and bortezomib following HSCT. The phase II portion will consist of two single-arm, open-label, optimal 2-stage Simon design studies conducted in two separate strata for HLA-matched and HLA-mismatched donor transplants.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 years * Karnofsky score ≥70% * No evidence of progressive bacterial, viral, or fungal infection * Creatinine clearance \>50 mL/min/1.72m2 * ALT and AST \<3 x the upper limit of normal * Total bilirubin \<2 x the upper limit of normal (except for Gilbert's syndrome) * ALP ≤250 IU/L * LVEF \>45% * Adjusted DLCO \>50% * Negative HIV serology * Negative pregnancy test: Confirmation per negative serum β-hCG * Willing to comply with all study procedures and be available for the duration of the study. Exclusion Criteria: * Pregnant or nursing females or women of reproductive capability who are unwilling to completely abstain from heterosexual sex or practice effective methods of contraception from start of conditioning through 90 days after the last dose of study drug. A woman of reproductive capability is one who has not undergone a hysterectomy (removal of the womb), has not had both ovaries removed, or has not been post-menopausal (stopped menstrual periods) for more than 24 consecutive months. * Male subjects who refuse to practice effective barrier contraception from the start of conditioning through a minimum of 90 days after the last dose of study drug, or completely abstain from heterosexual intercourse. This must be done even if they are surgically sterilized. * Inability to provide informed consent. * Patient had myocardial infarction within 6 months prior to enrollment or has NYHA Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at screening must be documented by the investigator as not medically relevant. * Known allergies to any of the components of the investigational treatment regimen. * Serious medical or psychiatric illness is likely to interfere with participation in this clinical study. * Diagnosed or treated for another malignancy within 3 years of enrollment, with the exception of complete resection of basal cell carcinoma or squamous cell carcinoma, an in-situ malignancy, or low-risk prostate cancer after curative therapy. * Participation in clinical trials with other investigational agents not included in this trial, within 14 days of the start of this trial and throughout the duration of this trial. * Prisoners * Pregnant women
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06681922 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Graft Vs Host Disease. 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 NCT06681922 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 NCT06681922 currently recruiting?
Yes, NCT06681922 is actively recruiting participants. Contact the research team at kcole5@northwell.edu for enrollment information.
Where is the NCT06681922 trial being conducted?
This trial is being conducted at Lake Success, United States.
Who is sponsoring the NCT06681922 clinical trial?
NCT06681922 is sponsored by Northwell Health. The trial plans to enroll 10 participants.