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

PHASE1PHASE2RECRUITING

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.

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Study details:

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).

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

Age ≥18 years.

Refractory or relapsed B cell malignancy.

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 CTX112 infusion.

Exclusion criteria

Prior allogeneic hematopoietic stem cell transplant (HSCT).

Active or 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 in the last 3 years (with the exception of non-melanoma skin cancer and other cancers deemed by the investigator and medical monitor to be of low likelihood for recurrence).

Concurrent systemic treatment with an anticancer biologic (e.g., monoclonal antibody) within 30 days prior to CTX112 infusion or with a nonbiological anticancer drug within 14 days prior to CTX112 infusion.

Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.

Women who are pregnant or breastfeeding.

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2023-03-10

Primary completion: 2030-01-01

Study completion finish: 2030-02-01

Study type

TREATMENT

Phase

PHASE1

PHASE2

Trial ID

NCT05643742

Intervention or treatment

BIOLOGICAL: CTX112

Conditions

• Non-Hodgkin Lymphoma
• Follicular Lymphoma
• Mantle Cell Lymphoma
• Marginal Zone Lymphoma
• Large B-cell Lymphoma
• B-cell Lymphoma
• B-cell Malignancy
• Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)

Condition: Non-Hodgkin Lymphoma, Follicular Lymphoma and more
BIOLOGICAL: CTX112
Nedlands, Western Australia, Australia
Sponsor: CRISPR Therapeutics AG

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Find a site

Closest Location:

Research Site

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Research Site
Nedlands, Western Australia, Australia

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?

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

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities	Not Specified	From CTX112 infusion up to 28 days post-infusion
Phase 2 (Cohort Expansion): Objective response rate	Not Specified	From CTX112 infusion up to 60 months post-infusion

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Duration of Response	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
Duration of Clinical Benefit (DOCB)	Not Specified	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	Not Specified	From date of CTX112 infusion until date of disease progression or death due to any cause, assessed up to 60 months
Overall Survival	Not Specified	From date of CTX112 infusion until date of death due to any cause, assessed up to 60 months

Frequently Asked Questions

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References

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