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

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: NCT05643742
Recruitment Status : Recruiting
First Posted : December 9, 2022
Last Update Posted : August 15, 2023
Sponsor:
Information provided by (Responsible Party):
CRISPR Therapeutics ( CRISPR Therapeutics AG )

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
B-cell Lymphoma Non-Hodgkin Lymphoma B-cell Malignancy Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) Follicular Lymphoma Mantle Cell Lymphoma Marginal Zone Lymphoma Large B-cell Lymphoma Biological: CTX112 Phase 1 Phase 2

Detailed Description:
This is an open-label, multi-center Phase 1/2 study of CTX112 in subjects with relapsed/refractory B cell malignancies. CTX112 is an is allogeneic CD19-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells 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).
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Open-Label, Multicenter, Dose Escalation and Cohort Expansion Study of the Safety and Efficacy of Anti-CD19 Allogeneic CRISPR-Cas9-Engineered T Cells (CTX112) in Subjects With Relapsed or Refractory B Cell Malignancies
Actual Study Start Date : March 10, 2023
Estimated Primary Completion Date : January 2030
Estimated Study Completion Date : February 2030

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CTX112
Administered by IV infusion following lymphodepleting chemotherapy.
 Biological: CTX112
CTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)


Outcome Measures
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Primary Outcome Measures :
  1. Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities [ Time Frame: From CTX112 infusion up to 28 days post-infusion ]
  2. Phase 2 (Cohort Expansion): Objective response rate [ Time Frame: From CTX112 infusion up to 60 months post-infusion ]

Secondary Outcome Measures :
  1. Duration of Response [ Time Frame: From date of first objective response of complete response (CR)/partial response (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. Duration of Clinical Benefit (DOCB) [ Time Frame: From date of first objective response of CR/PR until the relapse or death that followed the last response, assessed up to 60 months ]
  3. Progression Free Survival [ Time Frame: From date of CTX112 infusion until date of disease progression or death due to any cause, assessed up to 60 months ]
  4. Overall Survival [ Time Frame: From date of CTX112 infusion until date of death due to any cause, assessed up to 60 months ]

Eligibility Criteria
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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 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.
Contacts and Locations
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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): NCT05643742


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

Locations
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United States, Missouri
Research Site Recruiting
Saint Louis, Missouri, United States, 63110
United States, Texas
Research Site Recruiting
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
CRISPR Therapeutics AG
Investigators
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Study Director: Annie Weaver, PhD CRISPR Therapeutics
More Information
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Responsible Party: CRISPR Therapeutics AG
ClinicalTrials.gov Identifier: NCT05643742    
Other Study ID Numbers: CRSP-ONC-006
First Posted: December 9, 2022    Key Record Dates
Last Update Posted: August 15, 2023
Last Verified: August 2023
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
Neoplasms
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Mantle-Cell
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Leukemia, Lymphoid
Leukemia
Hematologic Diseases
Leukemia, B-Cell
Chronic Disease
Disease Attributes
Pathologic Processes