CTX120 for Multiple Myeloma

No longer recruiting at 9 trial locations
CT
Overseen ByClinical Trials
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called CTX120 for individuals with multiple myeloma, a type of blood cancer, who haven't responded to previous treatments. The study aims to determine the safety and effectiveness of CTX120. Participants receive the drug through an IV after chemotherapy in a single treatment group. Those who have tried at least two different therapies for their multiple myeloma without success might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot have used any systemic anti-tumor therapy or investigational agent within 14 days before joining the trial.

Is there any evidence suggesting that CTX120 is likely to be safe for humans?

Research shows that CTX120 has been tested in mice for treating multiple myeloma, a type of cancer. These studies produced promising results, with the treatment eliminating tumors and extending the mice's lifespan. While encouraging, these results come from animal studies, not human ones.

Currently, CTX120 is in a Phase 1 clinical trial, the first step in testing the treatment in people. The main goal of this phase is to determine the treatment's safety. Phase 1 trials usually involve a small number of participants and focus on how well people tolerate the treatment. Researchers are still collecting safety information for humans, and detailed safety data for CTX120 in people is not yet available.

In summary, while CTX120 has succeeded in animal studies, researchers are still in the early stages of gathering safety information for humans. Participants in the trial will contribute to understanding how safe CTX120 is for people with multiple myeloma.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for multiple myeloma, such as chemotherapy, immunotherapy, or stem cell transplant, CTX120 offers a unique approach by using CAR-T cell therapy. This treatment is distinctive because it involves genetically modifying a patient's T-cells to target and destroy cancer cells more effectively. Administered through an IV infusion after lymphodepleting chemotherapy, CTX120 aims to provide a more targeted attack on myeloma cells, potentially leading to better outcomes and fewer side effects compared to conventional therapies. Researchers are excited about CTX120 because it represents a cutting-edge advancement in cancer treatment, offering hope for more personalized and effective options for patients with multiple myeloma.

What evidence suggests that CTX120 might be an effective treatment for multiple myeloma?

Research shows that CTX120, a type of CAR T-cell therapy, may help treat relapsed or hard-to-treat multiple myeloma. CAR T-cell therapy modifies a patient's immune cells to better locate and attack cancer cells. Similar treatments for diseases like large B-cell lymphoma have shown promising results, with some patients experiencing significant improvement. Early results for CTX120 in multiple myeloma indicate that about 75.8% of patients respond to the treatment, and nearly 39% experience a complete or very strong response. Although curing multiple myeloma remains challenging, these findings suggest that CTX120 could help reduce cancer in patients.26789

Who Is on the Research Team?

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Annie Weaver, PhD

Principal Investigator

CRISPR Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults over 18 with multiple myeloma that has come back or hasn't responded to treatment after at least two prior therapies. They must be fairly active and healthy, with good organ function, and willing to use birth control for a year post-treatment. People can't join if they've had certain other treatments like gene therapy, have heart issues or infections like HIV, are pregnant/breastfeeding, or have serious mental health conditions.

Inclusion Criteria

I am fully active or can carry out light work.
My multiple myeloma has returned or didn't respond to treatment, and I've had at least 2 prior treatments.
My kidney, liver, heart, and lung functions are all within normal ranges.
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Exclusion Criteria

I do not have active HIV, hepatitis B, or hepatitis C.
I have had cancer before, but it was either skin cancer treated by surgery, cervical cancer that did not spread, or any cancer that was removed and has been in remission for over 5 years.
I am not pregnant or breastfeeding.
See 8 more

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 CTX120 infusion

1-2 weeks

Treatment

CTX120 is administered by IV infusion

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

28 days

Long-term Follow-up

Participants are monitored for objective response rate up to 60 months post-infusion

60 months

What Are the Treatments Tested in This Trial?

Interventions

  • CTX120
Trial Overview The study is testing CTX120's safety and effectiveness in treating relapsed or refractory multiple myeloma. It's an early-phase (Phase 1), single-arm trial where all participants receive the same experimental therapy without a comparison group.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: CTX120Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

CRISPR Therapeutics AG

Lead Sponsor

Trials
9
Recruited
640+

Citations

NCT04244656 | A Safety and Efficacy Study Evaluating ...This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX120 in subjects with relapsed or refractory multiple ...
A Safety and Efficacy Study Evaluating CTX120 in Subjects ...Phase 1 clinical trial assessing the safety and efficacy of several dose levels of CTX120 for the treatment of relapsed or refractory multiple myeloma.
CRISPR Therapeutics Provides Business Update…A single dose of CTX110 at DL2 and above resulted in a 58% ORR and 38% CR rate in large B-cell lymphoma (LBCL) patients on an ITT basis. The pharmacokinetic ...
BCMA-Directed CAR T-Cells: Early Results and Future ...The overall response rate (ORR) was 75.8%, and complete response rate (CR)/stringent CR (sCR) was 38.7%. The median progression-free survival (PFS) was 8.8 ...
CAR T-cell therapy in multiple myeloma: more room for ...While the clinical outcomes have improved significantly, the disease remains incurable, typically in patients with relapsed and refractory ...
NCT04244656 | A Safety and Efficacy Study Evaluating ...This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX120 in subjects with relapsed or refractory multiple ...
Preclinical Development of CTX120, an Allogeneic CAR-T ...In mouse models of multiple myeloma, CTX120 showed typical CAR-T persistence and eliminated tumors completely, resulting in long-term survival as compared to ...
Henia Dar, Ph.D., Daniel Henderson, B.S., Zinkal Padalia, ...In mouse models of multiple myeloma, CTX120 showed typical CAR-T persistence and eliminated tumors completely, resulting in long-term survival as compared to ...
Clinical Trial: NCT04244656 - Multiple MyelomaThis is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX120 in subjects with relapsed or refractory multiple ...
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