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

August 14, 2023 updated by: CRISPR Therapeutics AG

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Research Site
    • Texas
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From date of first objective response of CR/PR until the relapse or death that followed the last response, assessed up to 60 months
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
From date of CTX112 infusion until date of disease progression or death due to any cause, assessed up to 60 months
Overall Survival
Time Frame: From date of CTX112 infusion until date of death due to any cause, assessed up to 60 months
From date of CTX112 infusion until date of death due to any cause, assessed up to 60 months
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CRISPR Therapeutics AG

Investigators

  • Study Director: Annie Weaver, PhD, CRISPR Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2023

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

February 1, 2030

Study Registration Dates

First Submitted

November 30, 2022

First Submitted That Met QC Criteria

November 30, 2022

First Posted (Actual)

December 9, 2022

Study Record Updates

Last Update Posted (Actual)

August 15, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRSP-ONC-006

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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