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Gene Correction in Autologous CD34+ Hematopoietic Stem Cells (HbS to HbA) to Treat Severe Sickle Cell Disease

RecruitingPhase 1, Phase 2Ages 12 Years - 50 YearsAllKamau Therapeutics
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In plain words

What the trial is, and whether it could suit you

This study is a first-in-human, single-arm, open-label Phase I/II study of nula-cel in approximately 15 participants, diagnosed with severe Sickle Cell Disease. The primary objective is to evaluate safety of the treatment in this patient population, as well as preliminary efficacy and pharmacodynamic data.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * โ‰ฅ12 to โ‰ค 40 years * Severe disease, as defined by having experienced at least one of the following SCD-related events despite appropriate supportive care measures: * recurrent severe VOC (โ‰ฅ 4 episodes in the preceding 2 years) * ACS (โ‰ฅ 2 episodes in the prior 2 years with at least one episode in the past year) * Lansky/Karnofsky performance status of โ‰ฅ 80 Exclusion Criteria: * Available 10/10 HLA-matched sibling donor * Prior HSCT or gene therapy * Prior or current malignancy or myeloproliferative or a significant coagulation or immunodeficiency disorder * Clinically significant and active bacterial, viral, fungal or parasitic infection * Pregnancy or breastfeeding in a postpartum female * Presence of a chromosomal abnormality/mutation that may put the participant at an increased risk for MDS or AML per investigator's judgment
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What it tests

  • nula-cel Drug Product
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Where

6 sites
Children's Hospital Los Angeles
Los Angeles, United States
Lucile Packard Children's Hospital
Palo Alto, United States
Washington University
St Louis, United States
Columbia University Irving Medical Center
New York, United States
Memorial Sloan Kettering
New York, United States
Nationwide Children's Hospital
Columbus, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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