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NotableResults first posted: Apr 29, 2026v48Show 4 more changesShow less
Primary endpoints: 1 to 2
Interventions: Non-myeloablative haploidentical peripheral blood stem cell transplantation with briquilimab and abatacept (Drug) to Abatacept (Drug), Briquilimab (Biological), Cyclophosphamide (Drug), Filgrastim (Drug), Sirolimus (Drug)
Secondary endpoints revised (3)
Study arms: 2 to 3
MinorPrimary completion date changed from estimate of Nov 26, 2025 to Oct 27, 2025v47
Minor6 versionsRe-verified since Mar 24, 2025, no change to tracked fieldsv41-v46
NotableEnrollment target: estimated 72 to confirmed 6v40Show 4 more changesShow less
Primary completion date: Sep 1, 2032 to Nov 26, 2025
Trial status: Recruiting to Active, Not Recruiting
Study completion date: Mar 1, 2033 to Nov 26, 2027
Site details revised
Minor3 versionsRe-verified since Nov 14, 2024, no change to tracked fieldsv37-v39
Show 35 earlier versionsHide 35 earlier versions
MinorEligibility criteria shortened, about 6 wordsv36
Minor7 versionsRe-verified since Mar 23, 2024, no change to tracked fieldsv29-v35
MinorEligibility criteria expanded, about 10 wordsv28
Minor2 versionsRe-verified since Feb 1, 2024, no change to tracked fieldsv26-v27
MinorEligibility criteria expanded, about 6 words
Study description revised
v25
MinorStart date: Dec 29, 2023 to Dec 28, 2023v24
NotableTrial status: Not Yet Recruiting to Recruiting
Start date changed from estimate of Jan 4, 2024 to Dec 29, 2023
Site details revised
v23
MinorStart date: Jan 3, 2024 to Jan 4, 2024v22
MinorStart date: Jan 2, 2024 to Jan 3, 2024v21
MinorStart date: Jan 1, 2024 to Jan 2, 2024v20
MinorStart date: Dec 27, 2023 to Jan 1, 2024v19
MinorStart date: Dec 26, 2023 to Dec 27, 2023v18
MinorStart date: Dec 25, 2023 to Dec 26, 2023v17
MinorStart date: Dec 24, 2023 to Dec 25, 2023v16
MinorStart date: Dec 21, 2023 to Dec 24, 2023v15
MinorStart date: Dec 20, 2023 to Dec 21, 2023v14
MinorStart date: Dec 19, 2023 to Dec 20, 2023v13
MinorStart date: Dec 18, 2023 to Dec 19, 2023v12
MinorStart date: Dec 17, 2023 to Dec 18, 2023v11
MinorStart date: Dec 14, 2023 to Dec 17, 2023v10
MinorStart date: Dec 13, 2023 to Dec 14, 2023v9
MinorStart date: Dec 10, 2023 to Dec 13, 2023
Interventions: Non-myeloablative haploidentical peripheral blood stem celltransplantation with briquilimab and abatacept (Drug) to Non-myeloablative haploidentical peripheral blood stem cell transplantation with briquilimab and abatacept (Drug)
Eligibility criteria expanded, about 12 words
v8
MinorStart date: Dec 7, 2023 to Dec 10, 2023v7
MinorStart date: Dec 5, 2023 to Dec 7, 2023
Interventions: Cohort 1 (Combination Product), Cohort 2 (Combination Product) to Non-myeloablative haploidentical peripheral blood stem celltransplantation with briquilimab and abatacept (Drug)
Secondary endpoints: details revised at 3 of 3 entries
v6
MinorStart date: Dec 4, 2023 to Dec 5, 2023
Study title shortened, about 2 words
v5
MinorStart date: Dec 3, 2023 to Dec 4, 2023v4
MinorStart date: Nov 30, 2023 to Dec 3, 2023
Eligibility criteria expanded, about 4 words
v3
MinorStart date: Nov 28, 2023 to Nov 30, 2023v2
MinorStudy First Submitted
Stopped: an ongoing trial was terminated, suspended or withdrawn.
Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Background:
Sickle cell disease (SCD) is a genetic disorder where red blood cells, that carry oxygen, are stiff and become stuck in small blood vessels. As a result, affected patients can experience severe pain and serious organ damage. SCD can be cured with a hematopoietic cell transplant (HCT), that is, when they receive blood stem cells from a family donor. But HCT can also have serious side effects, especially in people with organ damage. Researchers want to find ways to make HCT safer for everyone.
Objective:
To test a new combination of drugs (briquilimab, abatacept, and alemtuzumab), used along with radiation, in people undergoing HCT for SCD.
Eligibility:
People aged 16 and older with SCD. They must be eligible for HCT and have a family member who is a good donor match. Donors must be aged 4 and older.
Design:
Participants with SCD will be screened. They will have blood tests and tests of organs including their heart and lung function. Donors will have blood drawn.
Participants with SCD will have a tube inserted into a blood vessel in their chest (intravenously). This line will remain in place up to 2 months; it will be used to draw blood and administer the donor cells and other medications.
Briquilimab will be administered intravenously 1 time, along with other drugs used to prepare for HCT. Participants will receive abatacept 6 times, from just before they receive their donor cells until 6 months after. Participants will undergo radiation therapy and take other drugs that are standard for HCT. Most HCT recipients remain in the hospital for about 30 days after HCT.
Follow-up visits will continue for 5 years....