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

Mantle Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05643742
• Other study ID #: CRSP-ONC-006
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: March 10, 2023
• Est. completion date: February 2030

Study information

• Verified date: August 2023
• Source: CRISPR Therapeutics
• Contact: Clinical Trials
• Phone: +1 (877) 214-4634
• Email: MedicalAffairs[@]crisprtx.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: February 2030
• Est. primary completion date: January 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• B-cell Lymphoma
• B-cell Malignancy
• Follicular Lymphoma
• Large B-cell Lymphoma
• Leukemia, Lymphocytic, Chronic, B-Cell
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Mantle-Cell
• Lymphoma, Non-Hodgkin
• Mantle Cell Lymphoma
• Marginal Zone Lymphoma
• Neoplasms
• Non-Hodgkin Lymphoma

Intervention

Biological:
• CTX112
CTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)

Locations

Country	Name	City	State
United States	Research Site	Saint Louis	Missouri
United States	Research Site	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
CRISPR Therapeutics AG

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities		From CTX112 infusion up to 28 days post-infusion
Primary	Phase 2 (Cohort Expansion): Objective response rate		From CTX112 infusion up to 60 months post-infusion
Secondary	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
Secondary	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
Secondary	Progression Free Survival		From date of CTX112 infusion until date of disease progression or death due to any cause, assessed up to 60 months
Secondary	Overall Survival		From date of CTX112 infusion until date of death due to any cause, assessed up to 60 months