Safety and Preliminary Efficacy of CTX112 in Adult Participants With Relapsed/Refractory Hematologic Autoimmune Disease

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
CRISPR Therapeutics AG
Study ID
NCT07549698
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • ITP - Immune Thrombocytopenia
  • Immune Thrombocytopenic Purpura
  • Warm Autoimmune Hemolytic Anemia
  • Warm Autoimmune Hemolytic Anemia (WAIHA)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CTX112 — 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

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).

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Dec 31, 2033
Completion
Dec 31, 2033

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CTX112 (zugo-cel)
    Administered by IV infusion following lymphodepleting chemotherapy

Primary Outcome Measure

To evaluate the safety of CTX112 in adult participants with refractory hematologic autoimmune diseases, including ITP or wAIHA. [ Time Frame: From CTX112 infusion up to 28 days post infusion. ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Research Site 2RochesterMinnesota55905-
Research Site 1OmahaNebraska68198-

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