Phase 2 Sickle Cell Disease Trial, Recruiting NCT04099966 Sponsor: Mitchell Cairo Condition: Sickle Cell Disease
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Phase 2 Sickle Cell Disease Trial, Recruiting

NCT04099966
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People diagnosed with high-risk Acute Lymphoblastic Leukemia (ALL) — a type of blood cancer — including cases with certain genetic changes, where initial treatment did not work well, or where the disease has come back after earlier treatment
  • People diagnosed with Acute Myeloid Leukemia (AML) — another type of blood cancer — where treatment did not work, where the disease has certain high-risk genetic features, where small amounts of leukemia cells remain after treatment, or where the disease has returned
  • People with high-risk Myelodysplastic Syndrome (MDS), a condition where the bone marrow does not make enough healthy blood cells
  • People with Hodgkin Lymphoma or Non-Hodgkin Lymphoma where initial treatment did not work, or where the disease has partially or fully responded to treatment but has since returned
  • People with certain rare bone marrow failure conditions (such as Kostmann syndrome, Diamond-Blackfan anemia, or amegakaryocytic thrombocytopenia) that have not responded to standard treatments
  • People with Sickle Cell Disease, including certain related forms involving abnormal hemoglobin
  • People aged 0 to 30 years old
  • People whose heart, liver, kidneys, and other organs are functioning well enough to meet the trial's health requirements (confirm specific thresholds with trial site)

Who may not be able to join:

  • People who are pregnant or currently breastfeeding
  • People who have an active infection that is not under control at the time of joining the trial
  • People whose overall physical functioning falls below a certain level on a standard medical performance scale (confirm specific score requirements with trial site)
  • People who have a documented history of not following through with medical care and treatment plans
  • People who have previously received a bone marrow/stem cell transplant from a donor within the last 6 months, unless the current procedure would be considered a "boost" to a prior transplant
  • People who currently have active Graft-versus-Host Disease (a complication where transplanted cells attack the body) below a certain severity level (confirm with trial site)

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

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Mitchell S Cairo, New York Medical College

Phone: 9145942150

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
Mitchell Cairo
Registry
ClinicalTrials.gov
Start date
1 April 2021
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov