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Trial record 10 of 30 for:    crispr

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

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ClinicalTrials.gov Identifier: NCT04035434
Recruitment Status : Recruiting
First Posted : July 29, 2019
Last Update Posted : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
CRISPR Therapeutics ( CRISPR Therapeutics AG )

Brief Summary:
This is a single-arm, open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.

Condition or disease Intervention/treatment Phase
B-cell Malignancy Non-Hodgkin Lymphoma B-cell Lymphoma Biological: CTX110 Phase 1 Phase 2

Detailed Description:
The study may enroll up to 95 subjects in total.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 95 participants
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2 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
Actual Study Start Date : July 22, 2019
Estimated Primary Completion Date : July 2026
Estimated Study Completion Date : August 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities [ Time Frame: From CTX110 infusion up to 28 days post-infusion ]
  2. Phase 2 (Cohort Expansion): Objective response rate [ Time Frame: From CTX110 infusion up to 60 months post-infusion ]

Secondary Outcome Measures :
  1. 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

  2. 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 ]
  3. Overall Survival [ Time Frame: From date of CTX110 infusion until date of death due to any cause, assessed up to 60 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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.

Key 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.

Information from the National Library of Medicine

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


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

Locations
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United States, Illinois
Research Site 4 Recruiting
Chicago, Illinois, United States, 60637
United States, Kansas
Research Site 2 Recruiting
Westwood, Kansas, United States, 66205
United States, Oregon
Research Site 5 Recruiting
Portland, Oregon, United States, 97239
United States, Tennessee
Research Site 1 Recruiting
Nashville, Tennessee, United States, 37203
Australia, Victoria
Research Site 3 Recruiting
Melbourne, Victoria, Australia, 3000
Sponsors and Collaborators
CRISPR Therapeutics AG
Investigators
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Study Director: Ewelina Morawa, MD CRISPR Therapeutics

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Responsible Party: CRISPR Therapeutics AG
ClinicalTrials.gov Identifier: NCT04035434     History of Changes
Other Study ID Numbers: CRSP-ONC-001
First Posted: July 29, 2019    Key Record Dates
Last Update Posted: November 19, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CRISPR Therapeutics ( CRISPR Therapeutics AG ):
CAR T
Non-Hodgkin Lymphoma
NHL
Lymphoma
Allogeneic
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases