A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04035434 |
Recruitment Status :
Recruiting
First Posted : July 29, 2019
Last Update Posted : January 8, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
B-cell Malignancy Non-Hodgkin Lymphoma B-cell Lymphoma | Biological: CTX110 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 131 participants |
Intervention Model: | Sequential Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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) |
Actual Study Start Date : | July 22, 2019 |
Estimated Primary Completion Date : | July 2026 |
Estimated Study Completion Date : | August 2026 |

Arm | Intervention/treatment |
---|---|
Experimental: CTX110
Administered by IV infusion following lymphodepleting chemotherapy.
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Biological: CTX110
CTX110 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components |
- Part A (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities [ Time Frame: From CTX110 infusion up to 28 days post-infusion ]
- Part B (Cohort Expansion): Objective response rate [ Time Frame: From CTX110 infusion up to 60 months post-infusion ]
- Duration of Response [ Time Frame: From date of first objective response of CR/PR until date of disease progression or death due to any cause, assessed up to 60 months ]Duration of Response (DOR) will only be reported for subjects who have had CR/PR events
- Progression Free Survival [ Time Frame: From date of CTX110 infusion until date of disease progression or death due to any cause, assessed up to 60 months ]
- Overall Survival [ Time Frame: From date of CTX110 infusion until date of death due to any cause, assessed up to 60 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Key Inclusion Criteria:
- Age ≥18 years.
- Refractory or relapsed non-Hodgkin lymphoma, as evidenced by 2 or more lines of prior therapy.
- Eastern Cooperative Oncology Group performance status 0 or 1.
- Adequate renal, liver, cardiac and pulmonary organ function
- 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.
- Agree to participate in an additional long-term follow-up study after completion of this study.
Key Exclusion Criteria:
- Treatment with any gene therapy or genetically modified cell therapy, including CAR T cells.
- Prior allogeneic HSCT.
- History of central nervous system (CNS) involvement by malignancy
- History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
- Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
- Active HIV, hepatitis B virus or hepatitis C virus infection.
- 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.
- Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of enrollment.
- Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
- Women who are pregnant or breastfeeding.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04035434
Contact: Clinical Trials | +1 (877) 214-4634 | MedicalAffairs@crisprtx.com |
United States, California | |
UCSF Medical Center | Recruiting |
San Francisco, California, United States, 94143 | |
Contact: Cancer Immunotherapy Program HDFCCC.CIP@ucsf.edu | |
United States, Florida | |
Mayo Clinic | Recruiting |
Jacksonville, Florida, United States, 32224 | |
United States, Georgia | |
Emory University Winship Cancer Institute | Recruiting |
Atlanta, Georgia, United States, 30322 | |
United States, Illinois | |
University of Chicago | Recruiting |
Chicago, Illinois, United States, 60637 | |
United States, Kansas | |
University of Kansas | Recruiting |
Westwood, Kansas, United States, 66205 | |
Contact: Joseph P McGuirk, DO 913-708-4032 jmcguirk@kumc.edu | |
Contact: Jeff Roesgen jroesgen@kumc.edu | |
United States, Oregon | |
Oregon Health and Science University | Recruiting |
Portland, Oregon, United States, 97239 | |
Contact: Richard Maziarz, MD maziarzr@ohsu.edu | |
Contact: Kevin Christmas, PhD 503-494-6474 christmk@ohsu.edu | |
United States, Tennessee | |
Sarah Cannon Research Institute | Recruiting |
Nashville, Tennessee, United States, 37203 | |
Contact: Ryan Birchfield 615-982-4833 ryan.birchfield@sarahcannon.com | |
United States, Texas | |
Texas Transplant Institute | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact: Paul Shaughnessy, MD Paul.Shaughnessy@MHShealth.com | |
Contact: Sherri Shade, RN, CCRC 210-575-4238 Sherri.Shade@MHShealth.com | |
Australia, New South Wales | |
Royal Prince Alfred Hospital | Recruiting |
Sydney, New South Wales, Australia, 2050 | |
Contact: Joy Ho, MBBS +61 2 95158036 christine.contacos@health.nsw.gov.au | |
Contact: Christine Contacos, PhD +61 2 95153370 christine.contacos@health.nsw.gov.au | |
Australia, Victoria | |
Peter MacCallum Cancer Centre | Recruiting |
Melbourne, Victoria, Australia, 3000 | |
Contact: Constantine Tam, MBBS, MD +61 3 8559 7858 constantine.tam@petermac.org | |
Contact: Michael Dickinson, MBBS, MD +61 3 8559 7858 michael.dickinson@petermac.org | |
Germany | |
University of Hamburg | Recruiting |
Hamburg, Germany, 20148 | |
Contact: Natascha von Huenerbein +49 (0) 40 7410-23181 n.von-huenerbein@uke.de | |
Contact: Marion Heinzelmann +49 (0) 40 7410 - 54188 mheinzel@uke.de |
Study Director: | Ewelina Morawa, MD | CRISPR Therapeutics |
Responsible Party: | CRISPR Therapeutics AG |
ClinicalTrials.gov Identifier: | NCT04035434 |
Other Study ID Numbers: |
CRSP-ONC-001 |
First Posted: | July 29, 2019 Key Record Dates |
Last Update Posted: | January 8, 2021 |
Last Verified: | January 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
CAR T Non-Hodgkin Lymphoma NHL Lymphoma Allogeneic |
Lymphoma Neoplasms Lymphoma, Non-Hodgkin Neoplasms by Histologic Type |
Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |