A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)

  • Interventional
  • Not Recruiting
  • NCT04035434
Eligibility Details Visit Clinicaltrials.gov

A Phase 1 Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Allogeneic CRISPR-Cas9-Engineered T Cells (CTX110) in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)

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

The study may enroll up to 143 subjects in total. CTX110 is a CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells prepared for the treatment of B cell malignancies. The cells are from healthy adult volunteer donors that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR-associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

Key Inclusion Criteria:

         1. For NHL patients: Age ≥18 years. For B cell ALL patients: age ≥18 years to ≤70 years

         2. Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of prior therapy, or histologically confirmed B cell ALL, refractory or relapsed.

         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.

        Key Exclusion Criteria:

         1. Treatment with any gene therapy or genetically modified cell therapy, including CAR T cells.

         2. For NHL patients: prior allogeneic HSCT. For B cell ALL patients: prior allogeneic HSCT within 6 months, and/or any evidence of GvHD.

         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. For NHL patients: Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of enrollment. For B cell ALL patients: Use of systemic antitumor therapy within 7 days of enrollment.

         9. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.

         10. Women who are pregnant or breastfeeding.

At a Glance

National Government IDNCT04035434

IRB#IRB18-1454

Lead SponsorCRISPR Therapeutics AG

Lead PhysicianMichael R. Bishop

Collaborator(s)N/A

EligibilityAll
18 Years and up
Not Recruiting