CTX112 for B-Cell Cancers

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: CRISPR Therapeutics AG

Must not be taking: Anticancer biologics, Nonbiological anticancer

Disqualifiers: CNS involvement, Seizure disorder, Infections, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

This trial is testing CTX112, a modified immune cell therapy, in patients with B-cell cancers that have returned or resisted other treatments. The therapy uses CRISPR-Cas9 to enhance donor immune cells to better target and attack cancer cells. CRISPR-Cas9 technology has been increasingly used in cancer immunotherapy, including the preparation of CAR T cells for antitumor therapy.

Will I have to stop taking my current medications?

The trial requires that you stop taking any nonbiological anticancer drugs at least 14 days before the CTX112 infusion and any anticancer biologics at least 30 days before the infusion.

What is the safety profile of molecular target anticancer drugs like CTX112?

Molecular target anticancer drugs, which may include treatments like CTX112, have been shown to significantly increase the risk of serious adverse events (SAEs) and fatal adverse events (FAEs) compared to placebo. This means that while these drugs can be effective, they also come with a higher risk of serious side effects, so careful monitoring is important. ^{1 2 3 4 5}

Research Team

Annie Weaver, PhD

Principal Investigator

CRISPR Therapeutics

Eligibility Criteria

Adults over 18 with certain B-cell cancers that have come back or didn't respond to treatment can join. They must be fairly active and healthy, with good heart, kidney, liver, and lung function. Participants need to use birth control during the trial and for a year after getting the study drug.

Inclusion Criteria

My kidney, liver, heart, and lung functions are all good.

I am 18 years old or older.

My B cell cancer has returned or is not responding to treatment.

Exclusion Criteria

I have had a stem cell transplant from a donor.

I have an ongoing serious infection needing IV treatment.

I am not pregnant or breastfeeding.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

Participants receive lymphodepleting chemotherapy prior to CTX112 infusion

1-2 weeks

Treatment

Participants receive CTX112 via IV infusion

4-6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

Treatment Details

Interventions

• CTX112 (CAR T-cell Therapy)

Trial Overview The trial is testing CTX112's safety and effectiveness in patients with various types of B-cell malignancies that are resistant or have relapsed. It's an early-phase study where everyone gets the same experimental therapy.

Participant Groups

Group I: CTX112 Experimental Treatment 1 Intervention

Administered by IV infusion following lymphodepleting chemotherapy.

Who Is Running the Clinical Trial?

CRISPR Therapeutics AG

Lead Sponsor

Trials

9

Recruited

640+

Findings from Research

In a study of 23,296 patients from 202 clinical trials, women were found to have a 34% higher risk of experiencing severe adverse events (AEs) from cancer treatments compared to men, with the risk increasing to 49% for those receiving immunotherapy.

Women experienced significantly more severe symptomatic and hematologic AEs across all treatment types, particularly with immunotherapy, highlighting the need for further research into sex differences in treatment responses and side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sex Differences in Risk of Severe Adverse Events in Patients Receiving Immunotherapy, Targeted Therapy, or Chemotherapy in Cancer Clinical Trials. Unger, JM., Vaidya, R., Albain, KS., et al.[2022]

A meta-analysis of 53 Phase II/III/IV trials involving nearly 20,000 patients revealed that molecular target anticancer drugs significantly increase the risk of serious adverse events (SAEs) by 57% and fatal adverse events (FAEs) by 51% compared to placebo.

The overall incidence rates for SAEs and FAEs were found to be 26.9% and 2.3%, respectively, highlighting the need for careful monitoring and preventive measures for patients receiving these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis. Wang, Z., Yang, X., Wang, J., et al.[2020]

A large-scale analysis of 16,196 serious adverse drug reaction reports identified 36 potential safety signals associated with ibrutinib, including ischemic heart diseases and fractures, highlighting the need for careful patient monitoring.

The study found that over half of the reports resulted in hospitalization, indicating that while ibrutinib is a standard treatment for B-cell malignancies, its safety profile requires further investigation to confirm these findings in broader populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of Ibrutinib: An Analysis of the WHO Pharmacovigilance Database. Allouchery, M., Tomowiak, C., Lombard, T., et al.[2021]

The Common Terminology Criteria for Adverse Events (CTCAE) has evolved through multiple versions to standardize the reporting of adverse events in clinical trials, improving accuracy and completeness.

However, the current version (CTCAE 3.0) is insufficient for coding subacute adverse events associated with modern targeted therapies, indicating a need for further updates to better capture these specific side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there room for improvement in adverse event reporting in the era of targeted therapies? Edgerly, M., Fojo, T.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sex Differences in Risk of Severe Adverse Events in Patients Receiving Immunotherapy, Targeted Therapy, or Chemotherapy in Cancer Clinical Trials. [2022]

2. India pubmed.ncbi.nlm.nih.gov

Risk of serious adverse event and fatal adverse event with molecular target anticancer drugs in cancer patients: A meta-analysis. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Safety Profile of Ibrutinib: An Analysis of the WHO Pharmacovigilance Database. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Use and misuse of common terminology criteria for adverse events in cancer clinical trials. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Is there room for improvement in adverse event reporting in the era of targeted therapies? [2019]