What side effects are associated with this type of intervention?

Common treatments for pancreatic adenocarcinoma, such as gemcitabine and nab-paclitaxel, are associated with several side effects. Gemcitabine can cause neutropenia, thrombocytopenia, and fatigue, while nab-paclitaxel may lead to neuropathy, neutropenia, and fatigue. S-1, an oral fluoropyrimidine, can result in hand-foot syndrome, nausea, and diarrhea. These side effects are important considerations when evaluating treatment options for pancreatic adenocarcinoma.

What prior FDA approvals exist?

The FDA has approved several treatments for Pancreatic Adenocarcinoma, focusing on chemotherapy and combination regimens. Gemcitabine, often used as a monotherapy or in combination with other agents like nab-paclitaxel, has been a cornerstone in treatment. The combination of gemcitabine and S-1, an oral fluoropyrimidine, has shown noninferior results compared to gemcitabine alone. Additionally, FOLFIRINOX, a combination of fluorouracil, leucovorin, irinotecan, and oxaliplatin, is another approved regimen that has demonstrated efficacy. These treatments aim to improve survival and manage symptoms in patients with advanced or metastatic pancreatic cancer.

What other types of research exist?

Promising novel alternatives to CTX131™ for pancreatic adenocarcinoma patients in 2024 include: 1) Pembrolizumab for patients with high microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR). 2) Nivolumab combined with ipilimumab for patients with specific genetic mutations or high tumor mutational burden (TMB). 3) PARP inhibitors like olaparib for patients with BRCA1/2 mutations. 4) Targeted therapies such as larotrectinib or entrectinib for tumors with NTRK gene fusions. These therapies have shown promise in clinical trials and offer new avenues for treatment.

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CAR T-cell Therapy

CTX131 for Resistant or Recurrent Cancer

Phase 1 & 2

Recruiting

Research Sponsored by CRISPR Therapeutics AG

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years

Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, endometrial carcinoma, and malignant pleural mesothelioma

Must not have

History of certain central nervous system (CNS), cardiac or pulmonary conditions

Women who are pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from ctx131 infusion up to 60 months post-infusion

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing CTX131, a treatment that uses modified immune cells to fight cancer, in patients whose cancer has come back or didn't respond to other treatments. The immune cells are changed using gene-editing technology to help them attack the cancer.

Who is the study for?

Adults over 18 with certain advanced cancers (like kidney, cervical, pancreatic cancer, and mesothelioma) that have come back or didn't respond to treatment. They must be in good physical condition and agree to use birth control for a year after getting the study drug.

What is being tested?

The trial is testing CTX131's safety and effectiveness on patients with specific solid tumors that are either untreatable or have returned after treatment. It's an early-phase study where everyone gets the same experimental therapy.

What are the potential side effects?

While not specified here, similar treatments often cause immune reactions, fatigue, nausea, potential organ inflammation, increased infection risk and may affect blood cell counts.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My cancer is advanced and cannot be removed by surgery.

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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a history of specific brain, heart, or lung conditions.

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I am not pregnant or breastfeeding.

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I have an immune system disorder or autoimmune disease and need steroids or other treatments to manage it.

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I have been treated with drugs targeting CD70 before.

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

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I have an infection that is not responding to treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from ctx131 infusion up to 60 months post-infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from ctx131 infusion up to 60 months post-infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and from ctx131 infusion up to 60 months post-infusion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase 1 (Dose Escalation): Incidence of adverse events

Phase 2 (Cohort Expansion): Objective response rate (ORR)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: CTX131Experimental Treatment1 Intervention

Administered by IV infusion following lymphodepleting chemotherapy.

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Pancreatic Adenocarcinoma include chemotherapy agents like gemcitabine, which inhibits DNA synthesis, and targeted therapies such as PARP inhibitors that exploit DNA repair weaknesses in cancer cells. Investigational therapies, including CAR T-cell therapy, are being explored for their ability to target specific antigens on tumor cells. These treatments are crucial for Pancreatic Adenocarcinoma patients as they offer potential options for managing a highly aggressive and often treatment-resistant cancer, improving survival rates and quality of life.

Emerging Therapies and Future Directions in Targeting the Tumor Stroma and Immune System in the Treatment of Pancreatic Adenocarcinoma.