Early Phase 1 Peripheral Arterial Disease Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who meet all of Johns Hopkins' internal requirements for a reduced-intensity stem cell transplant from a donor (using peripheral blood stem cells, not cord blood) — eligible donor types include matched related donors, half-matched (haploidentical) donors, matched unrelated donors, and mismatched unrelated donors.
• People who are 18 years of age or older.
• People whose organs are functioning well enough to safely undergo the transplant and take part in a clinical trial, including: blood cell counts within acceptable ranges (with transfusion or growth factor support allowed); liver function tests within acceptable limits; kidney function showing a creatinine level at or below 2.0 mg/dL; heart pumping function of at least 35%; and lung function at or above 50% of the expected normal level.
• People who have high levels of antibodies directed against their donor (called Donor Specific Antibodies), measured using the trial's specific scoring system, even if standard attempts to reduce those antibodies have already been tried.
• People for whom no other suitable donor is readily available.
• People whose case has been reviewed and approved by the bone marrow transplant medical team as a group.
• People who are willing and able to take part in a clinical trial.

Who may not be able to join:

• People who have previously been treated with Daratumumab (given under the skin) or any other anti-CD38 therapy (unless the trial is specifically a re-treatment study).
• People who have taken part in another clinical drug trial or used an investigational medical device within the past 4 weeks or within 5 half-lives of the investigational drug (whichever is longer).
• People who have had focused (focal) radiation therapy within 14 days before the planned transplant start date — except for palliative radiation used to manage symptoms, and only if it was not given to a measurable area of disease outside the bone marrow.
• People with chronic obstructive pulmonary disease (a serious lung condition) where lung function testing shows breathing capacity below 50% of the expected normal level.
• People with moderate or severe persistent asthma in the past 2 years, or asthma of any type that is not well controlled. People with mild, well-controlled asthma may still be eligible (confirm with trial site).
• People with a known allergy or sensitivity to boron, mannitol, sorbitol, steroids, monoclonal antibodies, human proteins, or related ingredients used in the trial medications.
• People who have been diagnosed with multiple myeloma or a condition called AL amyloidosis (a protein build-up disorder).
• People whose transplant plan involves a full-intensity (myeloablative) approach, or who would receive bone marrow or cord blood as the stem cell source rather than peripheral blood.
• People with a history of HIV infection at any point in their life.
• People who test positive for active hepatitis B virus infection. People with certain hepatitis B antibody results may still be eligible if a specific DNA blood test comes back negative — the trial site can clarify the details.
• People who test positive for hepatitis C, unless they have completed antiviral treatment and have had no detectable virus for at least 12 weeks after finishing that treatment.
• People with significant heart disease, including a heart attack within the 6 months before the transplant, unstable or poorly controlled heart conditions (such as unstable chest pain or moderate-to-severe heart failure), or a heart rhythm problem that is not controlled.

Important: Always verify eligibility with the trial site directly before applying.