ClinicalTrials.gg
CompletedNCT05795595Updated Nov 5, 2026

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

A Phase 1 interventional study of CTX131 in Clear Cell Renal Cell Carcinoma, Cervical Carcinoma and Esophageal Carcinoma, sponsored by CRISPR Therapeutics AG. Completed at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by CRISPR Therapeutics AG · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Sep 2025, 1 year 1 month ago, and no results have been posted to the registry.
Updated Nov 5, 2026Design changedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
19
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

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).

02

Conditions studied

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

Keywords

  • CAR-T
  • Allogeneic
  • Carcinoma
03

In context

Carcinoma, Renal Cell

2,037 studies on the registry are indexed under Carcinoma, Renal Cell; 395 are open to participants now.

This study's enrollment of 19 is below the median of 43 across 1,564 interventional studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

CRISPR Therapeutics AG is the lead sponsor of 12 studies on the registry; 5 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 1 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Key Inclusion Criteria:

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

Key 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 , virus or virus infection.
  5. Primary immunodeficiency disorder or active disease requiring and/or other therapy.
  6. Women who are pregnant or breastfeeding.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

ECOG performance status

A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.

0
Fully active, no restrictions.
1
Limited in strenuous activity, but walking and able to do light work, such as housework or office work.
2
Walking and able to look after yourself, but unable to work; up and about more than half of waking hours.
3
Able to look after yourself only in part; in bed or a chair more than half of waking hours.
4
Unable to look after yourself at all; in bed or a chair all day.

Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    CTX131

    Administered by IV infusion following lymphodepleting chemotherapy.

    Biological: CTX131

Interventions

  • BiologicalCTX131

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

06

What researchers measure

Primary outcomes

  1. Phase 1 (Dose Escalation): Incidence of adverse events

    Defined as dose-limiting toxicities

    Time frame: From CTX131 infusion up to 28 days post-infusion

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

    ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to appropriate response evaluation criteria for each disease histology

    Time frame: From CTX131 infusion up to 60 months post-infusion

07

Study locations

7 sites
  • Research Site 3
    Duarte, California 91010, United States
  • Research Site 7
    Chicago, Illinois 60637, United States
  • Research Site 6
    Boston, Massachusetts 02215, United States
  • Research Site 2
    St Louis, Missouri 63110, United States
  • Research Site 4
    Durham, North Carolina 27710, United States
  • Research Site 1
    Nashville, Tennessee 37203, United States
  • Research Site 5
    Houston, Texas 77030, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Design
Removed Phase 2
Nov 5, 2026
Show all 1 update
  1. Nov 5, 2026
    Design Removed Phase 2

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT05795595
Lead sponsor
CRISPR Therapeutics AG
Responsible party
Sponsor
First posted
Apr 3, 2023
Start date
Mar 13, 2023
Primary completion
Sep 18, 2025
Completion
Sep 18, 2025
Last update
Nov 5, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion