Purpose

This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Age ≥18 years.
  2. Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of prior therapy.
  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 CTX110 infusion.
  6. Agree to participate in an additional long-term follow-up study after completion of this study.

Exclusion Criteria

  1. Treatment with any gene therapy or genetically modified cell therapy, including CAR T cells.
  2. Prior allogeneic HSCT.
  3. History of central nervous system (CNS) involvement by malignancy
  4. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
  5. Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
  6. Active HIV, hepatitis B virus or hepatitis C virus infection.
  7. 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.
  8. Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of enrollment.
  9. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
  10. Women who are pregnant or breastfeeding.

Study Design

Phase
Phase 1
Study Type
Interventional
Intervention Model
Sequential Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
CTX110
Administered by IV infusion following lymphodepleting chemotherapy.
  • Biological: CTX110
    CTX110 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components

Recruiting Locations

University of Kansas
Westwood, Kansas 66205
Contact:
Joseph P McGuirk, DO
913-708-4032
jmcguirk@kumc.edu

More Details

Status
Recruiting
Sponsor
CRISPR Therapeutics AG

Study Contact

Clinical Trials
+1 (877) 214-4634
MedicalAffairs@crisprtx.com

Detailed Description

The study may enroll up to 95 subjects in total.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.