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Warm Autoimmune Hemolytic Anemia (WAIHA)GeneticsRare diseaseBiologicalPhase 1, Phase 2

What this study is

This is a single-arm, open-label, multicenter, ascending dose Phase 1/2 trial evaluating the safety and preliminary efficacy of CTX112 or Zugocabtagene geleucel (zugo-cel) in adult participants with relapsed/refractory primary Immune Thrombocytopenia (ITP) and relapsed/refractory primary Warm Autoimmune Hemolytic Anemia (wAIHA).

What's being tested

  • CTX112

    Intervention · BIOLOGICAL

    CTX112 (zugo-cel): CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components

Study details

Official title
A Phase 1/2 Dose Evaluation Trial of the Safety and Preliminary Efficacy of Anti CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease
Sponsor
CRISPR Therapeutics AG
Conditions
Warm Autoimmune Hemolytic Anemia (WAIHA) · ITP - Immune Thrombocytopenia · Warm Autoimmune Hemolytic Anemia · Immune Thrombocytopenic Purpura
Enrolling
60 people
Starts
2026-07-17
Est. completion
2033-12
Design
Open-label, single group, Phase 1, Phase 2
Record
View on ClinicalTrials.gov ↗