CTX130 for T-Cell Lymphoma

No longer recruiting at 10 trial locations

Overseen By Clinical Trials

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: CRISPR Therapeutics AG

Must not be taking: Steroids, Immunosuppressants

Disqualifiers: Prior SCT, CNS conditions, 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 explores a new treatment called CTX130 for individuals with certain types of blood cancer, specifically T-cell lymphoma or Diffuse Large B-Cell Lymphoma (DLBCL). The main goal is to determine if CTX130 is safe and effective. Administered by IV, CTX130 infuses directly into the bloodstream after chemotherapy. This study may suit someone with a confirmed diagnosis of these cancers who hasn't responded to other treatments. Participants must be able to perform daily activities without much difficulty and have good overall organ function. As a Phase 1 trial, participants will be among the first to receive CTX130, aiding researchers in understanding how this new treatment works in people.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on steroids or other immunosuppressive therapy for an autoimmune disease, you may not be eligible to participate.

Is there any evidence suggesting that CTX130 is likely to be safe for humans?

Research has shown that CTX130, a treatment for T-cell lymphoma that has returned or resisted other treatments, maintains a safety level patients can handle. In these studies, patients generally found the side effects manageable. Importantly, the treatment demonstrated promising results in combating the cancer. This suggests that CTX130 could be both beneficial and safe for patients who have already tried many other treatments. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

CTX130 is unique because it's a type of CAR-T cell therapy specifically designed for T-cell lymphoma, a condition where current treatments like chemotherapy or radiation often have limited success. Unlike traditional options, CTX130 involves engineering the patient's own T-cells to better recognize and attack cancer cells. This personalized approach not only promises a more targeted attack on the cancer but also holds the potential for longer-lasting remission. Researchers are excited because this could mean fewer side effects and better outcomes compared to existing treatments.

What evidence suggests that CTX130 might be an effective treatment for T-cell lymphoma?

Research has shown that CTX130, the treatment under study in this trial, holds promise for patients with T-cell lymphoma. In one study, 70% of patients who received higher doses of CTX130 responded well, with 30% experiencing complete cancer remission. Additionally, 90% of these patients benefited from disease stabilization. The treatment targets a protein called CD70 on cancer cells and employs CAR-T therapy, which modifies immune cells to enhance their ability to fight cancer. Overall, CTX130 has demonstrated potential in aiding patients who have already tried several treatments. ^{1 3 4 5 6}

Who Is on the Research Team?

Alissa Keegan, PhD

Principal Investigator

CRISPR Therapeutics

Are You a Good Fit for This Trial?

This trial is for adults over 18 with T cell malignancies or Diffuse Large B-Cell Lymphoma, who are relatively healthy (ECOG 0-1). They must be able to use contraception and have good kidney, liver, heart, and lung function. People with prior organ transplants, other active cancers or infections like HIV/HBV/HCV, pregnant/breastfeeding women, those with immune/autoimmune disorders needing treatment, previous stem cell transplant recipients or anti-CD70 therapy patients can't join.

Inclusion Criteria

I agree to use birth control from enrollment through 12 months after treatment.

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

I have been diagnosed with a T cell malignancy or DLBCL.

Exclusion Criteria

I have an immune system disorder or autoimmune disease treated with steroids or other immune-suppressing drugs.

Pregnant or breastfeeding females.

I do not have active HIV, hepatitis B, or hepatitis C.

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 CTX130 infusion

1-2 weeks

Treatment

CTX130 is administered by IV infusion

1 day

Initial Follow-up

Participants are monitored for adverse events post-infusion

4 weeks

Long-term Follow-up

Participants are monitored for objective response rate

60 months

What Are the Treatments Tested in This Trial?

Interventions

• CTX130

Trial Overview The study is testing CTX130's safety and effectiveness in treating relapsed/refractory T or B cell malignancies. It's a Phase 1 trial where all participants receive the same experimental therapy without comparison to a control group. The trial is open-label meaning both researchers and participants know what treatment is being given.

How Is the Trial Designed?

Group I: CTX130 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. crisprtx.com crisprtx.com/about-us/press-releases-and-presentations/crispr-therapeutics-presents-positive-results-from-its-phase-1-cobalt-lym-trial-of-ctx130-in-relapsed-or-refractory-t-cell-malignancies-at-the-2022-european-hematology-association-eha-congress

LYM Trial of CTX130™ in Relapsed or Refractory T Cell ... At DL3 and above, ORR was 70% with 30% of patients achieving a CR. In addition, 90% of patients at DL3+ had clinical benefit defined as a stable disease or ...

2. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00508-4/abstract

Safety and activity of CTX130, a CD70-targeted allogeneic ... In patients with heavily pretreated T-cell lymphoma, CTX130 showed manageable safety and a promising objective response rate. This study shows ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1470204524005084

Safety and activity of CTX130, a CD70-targeted allogeneic ... In patients with heavily pretreated T-cell lymphoma, CTX130 showed manageable safety and a promising objective response rate. This study shows that allogeneic, ...

4. hematologyadvisor.com hematologyadvisor.com/news/lymphoma-tcell-cd70-directed-cart-therapy-promising-treatment/

CD70-Directed CAR-T Therapy Shows Promise in T-Cell ... There were 41.0% of patients who received more than 1 CTX130 infusion and 67% of patients received dose level 4. During a median follow-up of ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04502446

NCT04502446 | A Safety and Efficacy Study Evaluating ... This is a single-arm, open-label, multicenter, Phase 1 study evaluating the safety and efficacy of CTX130 in subjects with relapsed or refractory T or B cell ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39617017/

Safety and activity of CTX130, a CD70-targeted allogeneic ... This study shows that allogeneic, readily available CAR T cells can be safely given to patients with relapsed or refractory T-cell lymphoma.