CTX110 for B-Cell Cancers

No longer recruiting at 33 trial locations

Overseen By Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: CRISPR Therapeutics AG

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: CNS involvement, Infections, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CTX110 to determine its safety and effectiveness for individuals with certain B-cell cancers that have recurred or resisted previous treatments. CTX110 is administered through an IV following some chemotherapy. Individuals who have undergone at least two rounds of treatment for non-Hodgkin lymphoma or specific types of B-cell acute lymphoblastic leukemia may be suitable candidates. Participants should manage daily activities independently and have normal kidney, liver, heart, and lung function. As a Phase 1, Phase 2 trial, this research aims to understand how CTX110 works in people and measure its effectiveness in an initial, smaller group, offering participants a chance to contribute to groundbreaking cancer treatment advancements.

Will I have to stop taking my current medications?

The trial requires that participants stop using systemic anti-tumor therapy before receiving CTX110. For NHL patients, this means stopping at least 14 days or 5 half-lives before the infusion, and for B cell ALL patients, at least 7 days before. The protocol does not specify other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that CTX110 is likely to be safe for humans?

Research has shown that CTX110 has been safe in earlier studies. These studies found that CTX110, a treatment using specially modified cells to fight cancer, was well-tolerated by patients with B-cell cancers. The safety data indicate that most people do not experience severe side effects. This information reassures those considering joining a trial about the safety of CTX110. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for B-cell cancers, which often include chemotherapy and antibody therapies, CTX110 is a cutting-edge CAR T-cell therapy. Researchers are excited about CTX110 because it genetically modifies a patient's own T-cells to specifically target and destroy cancerous B-cells, offering a more personalized and potentially effective approach. Additionally, this treatment is administered through a single IV infusion following lymphodepleting chemotherapy, which could simplify the treatment process compared to multiple rounds of conventional chemotherapy. This new approach has the potential to provide longer-lasting remissions and fewer side effects.

What evidence suggests that CTX110 might be an effective treatment for B-cell cancers?

Research shows that CTX110, which participants in this trial will receive, may help treat B-cell cancers. In earlier studies, CTX110 achieved a 58% overall response rate, meaning more than half of the patients experienced a reduction or disappearance of their cancer. Additionally, 38% of patients had a complete response, with no signs of cancer after treatment. These results came from patients with relapsed or hard-to-treat large B-cell lymphoma, a type of aggressive cancer. CTX110 is a form of CAR-T cell therapy, which uses specially modified immune cells to find and destroy cancer cells. These findings suggest that CTX110 could be a promising option for those with challenging B-cell cancers. ^{2 3 5 6 7}

Who Is on the Research Team?

Annie Weaver, PhD

Principal Investigator

CRISPR Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults with B-cell malignancies like non-Hodgkin's lymphoma or acute lymphoblastic leukemia that didn't respond to at least two prior treatments. Participants must be in good physical condition, have well-functioning major organs, and not be pregnant or breastfeeding. They should agree to use contraception and join a follow-up study.

Inclusion Criteria

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

I am fully active or can carry out light work.

Agree to participate in an additional long-term follow-up study after completion of this study.

Exclusion Criteria

I have had cancer before, but it was either skin cancer treated by surgery, cervical in situ carcinoma, or any cancer in remission for 5+ years.

I do not have an ongoing serious infection requiring IV drugs.

I have had a stem cell transplant from a donor for my lymphoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Lymphodepleting Chemotherapy

Participants receive lymphodepleting chemotherapy prior to CTX110 infusion

1-2 weeks

Treatment

CTX110 is administered by IV infusion

1 day

Follow-up

Participants are monitored for safety and effectiveness after treatment

60 months

What Are the Treatments Tested in This Trial?

Interventions

• CTX110

Trial Overview The CARBON trial is testing the safety and effectiveness of CTX110, a new therapy for people with certain blood cancers that have come back or haven't responded to treatment. It's an early-phase study where everyone gets the same experimental treatment.

How Is the Trial Designed?

Group I: CTX110 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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04035434

NCT04035434 | A Safety and Efficacy Study Evaluating ... This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.

2. crisprtx.com crisprtx.com/about-us/press-releases-and-presentations/crispr-therapeutics-reports-positive-top-line-results-from-its-phase-1-carbon-trial-of-ctx110-in-relapsed-or-refractory-cd19-b-cell-malignancies

CRISPR Therapeutics Reports Positive Top-Line… CRISPR Therapeutics Reports Positive Top-Line Results from Its Phase 1 CARBON Trial of CTX110™ in Relapsed or Refractory CD19+ B-cell Malignancies. -50% (2/4) ...

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2021.39.15_suppl.TPS7570

A phase 1 dose escalation and cohort expansion study of ... The Phase 1 CARBON trial (NCT04035434) is an open-label, multicenter, global study evaluating the safety and efficacy of CTX110 in pts ≥18 y with R/R DLBCL NOS.

4. crisprtx.gcs-web.com crisprtx.gcs-web.com/news-releases/news-release-details/crispr-therapeutics-reports-positive-results-its-phase-1-carbon

Press Release - CRISPR Therapeutics -58% overall response rate (ORR) and 38% complete response (CR) rate in large B-cell lymphoma (LBCL) with a single dose of CTX110 at Dose ...

5. clin.larvol.com clin.larvol.com/trial-detail/NCT04035434

A Safety and Efficacy Study Evaluating CTX110 in Subjects ... CRISPR Therapeutics Reports Positive Top-Line Results from Its Phase 1 CARBON Trial of CTX110 in Relapsed or Refractory CD19+ B-cell Malignancies. P1, N=95 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04035434

NCT04035434 | A Safety and Efficacy Study Evaluating ... This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX110 in subjects with relapsed or refractory B-cell malignancies.

7. kucancercenter.org kucancercenter.org/cancer-clinical-trials/find-trial/clinical-trial-results/nct04035434

A Phase I/II Dose Escalation and Cohort Expansion Study ... Preventable Cancers ... Safety and Efficacy of Allogeneic CRISPR-Cas9?Engineered T Cells CTX110 in Subjects with Relapsed or Refractory B-Cell Malignancies.