A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies
Study Details
Study Description
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 |
|---|---|---|
|
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
Arms and Interventions
| 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
Primary Outcome Measures
- Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities [From CTX112 infusion up to 28 days post-infusion]
- Phase 2 (Cohort Expansion): Objective response rate [From CTX112 infusion up to 60 months post-infusion]
Secondary Outcome Measures
- Duration of Response [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
- Duration of Clinical Benefit (DOCB) [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 [From date of CTX112 infusion until date of disease progression or death due to any cause, assessed up to 60 months]
- Overall Survival [From date of CTX112 infusion until date of death due to any cause, assessed up to 60 months]
Eligibility Criteria
Criteria
Key Inclusion Criteria:
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Age ≥18 years.
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Refractory or relapsed B cell malignancy.
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Eastern Cooperative Oncology Group performance status 0 or 1.
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Adequate renal, liver, cardiac and pulmonary organ function.
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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:
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Prior allogeneic hematopoietic stem cell transplant (HSCT).
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Active or history of central nervous system (CNS) involvement by malignancy.
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History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement.
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Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
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Active HIV, hepatitis B virus or hepatitis C virus infection.
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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.
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Use of systemic anti-tumor therapy or investigational agent within 14 days or 5 half-lives, whichever is longer, of enrollment.
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Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
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Women who are pregnant or breastfeeding.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- CRISPR Therapeutics AG
Investigators
- Study Director: Sarah Cohen, MD, CRISPR Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CRSP-ONC-006