A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies

Part of paid clinical trials in Westwood, Kansas.

Sponsor
CRISPR Therapeutics AG
Study ID
NCT05643742
Phase
PHASE1/PHASE2
Status
Recruiting

Conditions

  • B-cell Lymphoma
  • B-cell Malignancy
  • Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
  • Follicular Lymphoma
  • Large B-cell Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Non-Hodgkin Lymphoma

Eligibility Criteria

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

Interventions

  • CTX112 — BIOLOGICAL
    CTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)

Study Details

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX112™ in subjects with relapsed or refractory B-cell malignancies.

Key Dates

Start date
Mar 10, 2023
Status verified
Nov 2025
Primary completion
Jan 31, 2030
Completion
Feb 28, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CTX112
    Administered by IV infusion following lymphodepleting chemotherapy.

Primary Outcome Measure

Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities [ Time Frame: From CTX112 infusion up to 28 days post-infusion ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of KansasWestwoodKansas66205-
Washington UniversitySt LouisMissouri63110-
SCRISan AntonioTexas78229-
University of UtahSalt Lake CityUtah84112-

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