For Healthcare Professionals

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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Age ≥18 years.
  2. Refractory or relapsed B cell malignancy.
  3. Eastern Cooperative Oncology Group performance status 0 or 1.
  4. Adequate renal, liver, cardiac and pulmonary organ function.
  5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX112 infusion. Key

EXCLUSION CRITERIA

  1. Prior allogeneic hematopoietic stem cell transplant (HSCT).
  2. Active or history of central nervous system (CNS) involvement by malignancy.
  3. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
  4. Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
  5. Active HIV, hepatitis B virus or hepatitis C virus infection.
  6. Previous or concurrent malignancy, except basal cell or squamous cell skin carcinoma, adequately resected and in situ carcinoma of cervix, or a previous malignancy that was completely resected and has been in remission for ≥5 years.
  7. Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of enrollment.
  8. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
  9. Women who are pregnant or breastfeeding.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +1 (877) 214-4634Email iconEmail Study Center

Study’s details


Contition

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

Age (in years)

18 - 200

Phase

Phase 1/Phase 2

Participants needed

120

Est. Completion Date

Feb 2030

Treatment type

Interventional


Sponsor

CRISPR Therapeutics

ClinicalTrials.gov identifier

NCT05643742

Study number

CRSP-ONC-006

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