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RecruitingNCT05643742Updated Nov 14, 2025

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

A Phase 1/2 interventional study of CTX112 in B-cell Lymphoma, Non-Hodgkin Lymphoma and B-cell Malignancy, sponsored by CRISPR Therapeutics AG. Recruiting at 7 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-14.

Sponsored by CRISPR Therapeutics AG · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2023; still recruiting 3 years 8 months later.
Phase
Phase 1/2
Study type
Interventional
Enrollment
120
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 CTX112™ in subjects with relapsed or refractory B-cell malignancies.

Read the detailed description

This is an open-label, multi-center Phase 1/2 study of CTX112 in subjects with relapsed/refractory B cell malignancies. CTX112 is an is allogeneic CD19-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

  • B-cell Lymphoma
  • Non-Hodgkin Lymphoma
  • B-cell Malignancy
  • Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
  • Follicular Lymphoma
  • Mantle Cell Lymphoma
  • Marginal Zone Lymphoma
  • Large B-cell Lymphoma

Keywords

  • CAR T
  • Non-Hodgkin Lymphoma (NHL)
  • Lymphoma
  • Allogeneic
03

In context

Lymphoma, B-Cell

885 studies on the registry are indexed under Lymphoma, B-Cell; 286 are open to participants now.

This study's planned enrollment of 120 is above the median of 34 across 773 interventional studies indexed under Lymphoma, B-Cell.

Browse Lymphoma, B-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. or relapsed B cell .
  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 CTX112 infusion.

Key Exclusion Criteria:

  1. Prior hematopoietic stem cell transplant (HSCT).
  2. Active or history of central nervous system (CNS) involvement by malignancy.
  3. History of a seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any disease with CNS involvement.
  4. Presence of bacterial, viral, or fungal infection that is uncontrolled or requires IV anti-infectives.
  5. Active , virus or virus infection.
  6. Previous or concurrent malignancy in the last 3 years (with the exception of non-melanoma skin cancer and other cancers deemed by the investigator and medical monitor to be of low likelihood for recurrence).
  7. Concurrent systemic treatment with an anticancer biologic (e.g., monoclonal antibody) within 30 days prior to CTX112 infusion or with a nonbiological anticancer drug within 14 days prior to CTX112 infusion.
  8. Primary immunodeficiency disorder or active autoimmune disease requiring and/or other therapy.
  9. Women who are pregnant or breastfeeding.
Terms in these criteria, in plain language(12)

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.

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.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

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.

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.

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 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    CTX112

    Administered by IV infusion following lymphodepleting chemotherapy.

    Biological: CTX112

Interventions

  • BiologicalCTX112

    CTX112 (CD19-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 CTX112 infusion up to 28 days post-infusion

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

    Time frame: From CTX112 infusion up to 60 months post-infusion

Secondary outcomes

  1. Duration of Response

    Duration of Response (DOR) will only be reported for subjects who have had CR/PR events

    Time frame: From date of first objective response of complete response (CR)/partial response (PR) until date of disease progression or death due to any cause, assessed up to 60 months

  2. Duration of Clinical Benefit (DOCB)

    Time frame: From date of first objective response of CR/PR until the relapse or death that followed the last response, assessed up to 60 months

  3. Progression Free Survival

    Time frame: From date of CTX112 infusion until date of disease progression or death due to any cause, assessed up to 60 months

  4. Overall Survival

    Time frame: From date of CTX112 infusion until date of death due to any cause, assessed up to 60 months

07

Study locations

7 of 7 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05643742
Lead sponsor
CRISPR Therapeutics AG
Responsible party
Sponsor
First posted
Dec 9, 2022
Start date
Mar 10, 2023
Primary completion
Jan 2030 (estimated)
Completion
Feb 2030 (estimated)
Last update
Nov 14, 2025

Study contacts

Clinical Trials
Contact
MedicalAffairs@crisprtx.com
+1 (877) 214-4634
Melanie Allen, M.Sc.
study director · CRISPR Therapeutics

Oversight

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

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Studies of the drug tested here: Allogeneic CRISPR-Cas9 Engineered Anti-CD19 CAR T-cells CTX112

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