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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05643742




Registration number
NCT05643742
Ethics application status
Date submitted
30/11/2022
Date registered
9/12/2022
Date last updated
28/08/2024

Titles & IDs
Public title
A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies
Scientific 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
Secondary ID [1] 0 0
CRSP-ONC-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
B-cell Lymphoma 0 0
Non-Hodgkin Lymphoma 0 0
B-cell Malignancy 0 0
Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL) 0 0
Follicular Lymphoma 0 0
Mantle Cell Lymphoma 0 0
Marginal Zone Lymphoma 0 0
Large B-cell Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Other - CTX112

Experimental: CTX112 - Administered by IV infusion following lymphodepleting chemotherapy.


Treatment: Other: CTX112
CTX112 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Phase 1 (Dose Escalation): Incidence of adverse events, defined as dose-limiting toxicities
Timepoint [1] 0 0
From CTX112 infusion up to 28 days post-infusion
Primary outcome [2] 0 0
Phase 2 (Cohort Expansion): Objective response rate
Timepoint [2] 0 0
From CTX112 infusion up to 60 months post-infusion
Secondary outcome [1] 0 0
Duration of Response
Timepoint [1] 0 0
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 outcome [2] 0 0
Duration of Clinical Benefit (DOCB)
Timepoint [2] 0 0
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 outcome [3] 0 0
Progression Free Survival
Timepoint [3] 0 0
From date of CTX112 infusion until date of disease progression or death due to any cause, assessed up to 60 months
Secondary outcome [4] 0 0
Overall Survival
Timepoint [4] 0 0
From date of CTX112 infusion until date of death due to any cause, assessed up to 60 months

Eligibility
Key inclusion criteria
Key

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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 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).
7. 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.
8. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
9. Women who are pregnant or breastfeeding.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/03/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2030
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Melbourne
Recruitment hospital [3] 0 0
Research Site - Nedlands
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Kansas
Country [2] 0 0
United States of America
State/province [2] 0 0
Missouri
Country [3] 0 0
United States of America
State/province [3] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
CRISPR Therapeutics AG
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT05643742
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Annie Weaver, PhD
Address 0 0
CRISPR Therapeutics
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Clinical Trials
Address 0 0
Country 0 0
Phone 0 0
+1 (877) 214-4634
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05643742