A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed or Refractory Solid Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-13

Study Completion Date

2025-09-18

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This is an open-label, multicenter, Phase 1/2 study evaluating the safety and efficacy of CTX131™ in subjects with relapsed or refractory solid tumors.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Safety and Efficacy Study Evaluating CTX131 in Adult Subjects With Relapsed/Refractory Hematologic Malignancies

NCT06492304

T Cell Lymphoma B Cell Lymphoma Acute Myeloid Leukemia

RECRUITING PHASE1/PHASE2

A Safety and Efficacy Study Evaluating CTX112 in Subjects With Relapsed or Refractory B-Cell Malignancies

NCT05643742

B-cell Lymphoma Non-Hodgkin Lymphoma B-cell Malignancy +5 more

RECRUITING PHASE1/PHASE2

A Safety and Efficacy Study Evaluating CTX130 in Subjects With Relapsed or Refractory Renal Cell Carcinoma (COBALT-RCC)

NCT04438083

Renal Cell Carcinoma

TERMINATED PHASE1

A Safety and Efficacy Study Evaluating CTX110 in Subjects With Relapsed or Refractory B-Cell Malignancies (CARBON)

NCT04035434

B-cell Malignancy Non-Hodgkin Lymphoma B-cell Lymphoma +1 more

TERMINATED PHASE1/PHASE2

A Safety and Efficacy Study Evaluating CTX120 in Subjects With Relapsed or Refractory Multiple Myeloma

NCT04244656

Multiple Myeloma

TERMINATED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

An open-label, multi-center Phase 1/2 study of CTX131 in subjects with relapsed/refractory solid tumors. CTX131 is an is allogeneic CD70- directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells that are genetically modified ex vivo using CRISPR-Cas9 (clustered regularly interspaced short palindromic repeats/ CRISPR associated protein 9) gene editing components (single guide RNA and Cas9 nuclease).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Clear Cell Renal Cell Carcinoma Cervical Carcinoma Esophageal Carcinoma Pancreatic Adenocarcinoma Malignant Pleural Mesothelioma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CTX131

Administered by IV infusion following lymphodepleting chemotherapy.

Group Type EXPERIMENTAL

CTX131

Intervention Type BIOLOGICAL

CTX131 (CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CTX131

CTX131 (CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components)

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Age ≥18 years.
2. Unresectable or metastatic, relapsed/refractory, clear cell renal cell carcinoma, cervical carcinoma, pancreatic adenocarcinoma, esophageal carcinoma, and malignant pleural mesothelioma.
3. Eastern Cooperative Oncology Group performance status 0 or 1.
4. Adequate renal, liver, cardiac and pulmonary organ function.
5. Female subjects of childbearing potential and male subjects must agree to use acceptable method(s) of contraception from enrollment through at least 12 months after CTX131 infusion.

Exclusion Criteria

1. Prior treatment with anti-CD70 targeting agents
2. History of certain central nervous system (CNS), cardiac or pulmonary conditions.
3. Presence of uncontrolled bacterial, viral, or fungal infection.
4. Active HIV, hepatitis B virus or hepatitis C virus infection.
5. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy.
6. Women who are pregnant or breastfeeding.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No