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

Last updated: June 27, 2025
Sponsor: CRISPR Therapeutics
Overall Status: Active - Recruiting

Phase

1/2

Condition

Lymphoma

Non-hodgkin's Lymphoma

Lymphoma, B-cell

Treatment

CTX131

Clinical Study ID

NCT06492304
CRSP-ONC-008
  • Ages 18-100
  • All Genders

Study Summary

This is an open label, multicenter, phase 1/2 dose evaluation and cohort expansion study evaluating the safety and efficacy of CTX131 in subjects with Relapsed/Refractory Hematologic Malignancies

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. ≥18 years of age

  2. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (ECOG status of 2 will be permitted for subjects with AML)

  3. Diagnosed with r/r T Cell Lymphoma (TCL), B Cell Lymphoma (BCL), or Acute MyeloidLeukemia (AML) T cell lymphoma, including Stage ≥IIB Mycosis fungoides (MF)/ Sézarysyndrome (SS) after at least 2 prior systemic therapies Peripheral T cell lymphoma (PTCL) after at least 1 prior line of therapy (PTCL-note otherwise specified (NOS),PTCL-T follicular helper (TFH), Angioimmunoblastic T cell lymphoma (AITL), Adult Tcell leukemia/lymphoma (ATLL) of leukemic, lymphomatous, and chronic unfavorablesubtypes), (ALK)- ALCL after at least 1 prior line of therapy, ALK+ Anaplastic largecell lymphoma (ALCL) after at least 2 prior lines of therapy B cell lymphoma, including Diffuse large B cell lymphoma (DLBCL)-NOS, transformedmarginal zone lymphoma(MZL), transformed FL, high-grade BCL with MYC and BCL2 and/orBCL6 rearrangements, Follicular lymphoma (FL) grade 3b, after at least 2 prior linesof therapy including an anti- CD20 monoclonal antibody and an anthracyclinecontaining regimen Mantle cell lymphoma (MCL) after up to 5 prior lines of therapywhich must include an anthracycline- or bendamustine-containing regimen, an anti-CD20 monoclonal antibody, and a BTK inhibitor Acute myeloid leukemia or AML/MDS per ELN criteria 2022 after at least 1 prior lineof AML therapy. APL, BCR-ABL positive leukemia, and AML secondary to prior therapyor history of genetic syndrome associated with BM failure are excluded.

  4. Adequate renal, liver, cardiac and pulmonary organ function

  5. Females of childbearing potential and male subjects must agree to use an acceptable,highly effective method of contraception (as specified in the protocol) fromenrollment through at least 12 months after last CTX131 infusion

Exclusion

Exclusion Criteria:

  1. Prior treatment with anti-CD70 targeting agents

  2. Active CNS manifestation of underlying disease

  3. History or presence of clinically relevant CNS pathology such as seizure, stroke,severe brain injury, cerebellar disease, myelopathy, history of posterior reversibleencephalopathy syndrome with prior therapy, or another condition that in opinion ofinvestigator may increase CAR T-related toxicities

  4. Uncontrolled bacterial, viral, or fungal infection

  5. Positive for HIV, or active hepatitis B virus or hepatitis C virus infection.

  6. Concurrent systemic treatment with an anticancer biologic (e.g., monoclonalantibody) within 30 days prior to CTX131 infusion or with a non-biologicalanticancer drug within 14 days prior to CTX131 infusion. Mogamulizumab treatment isprohibited 50 days prior to CTX131 infusion.

  7. Diagnosis with another invasive malignancy in the last 5 years with the exception ofnon- melanoma skin cancer and malignancies deemed by the investigator and medicalmonitor to be of low likelihood for recurrence

  8. Primary immunodeficiency disorder or active autoimmune disease requiring steroidsand/or other immunosuppressive therapy.

  9. Prior solid organ or allogeneic BM transplantation, except for AML cohorts if atleast 3 months since allogeneic HSCT, not receiving immunosuppressive therapy ordonor lymphocyte infusion post SCT in the 2 weeks prior to lymphodepletion, and haveno clinically active GvHD

  10. Treatment with CD19-targeting CAR-T within 6 months prior to CTX131 infusion

Study Design

Total Participants: 290
Treatment Group(s): 1
Primary Treatment: CTX131
Phase: 1/2
Study Start date:
August 13, 2024
Estimated Completion Date:
November 30, 2030

Study Description

The study may enroll up to 290 subjects in total. CTX131 is a CD70-directed chimeric antigen receptor (CAR) T cell immunotherapy comprised of allogeneic T cells prepared for the treatment of relapsed/refractory hematological malignancies. The cells are from healthy adult volunteer donors 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)

Connect with a study center

  • Research Site 7

    East Melbourne, Victoria 3002
    Australia

    Active - Recruiting

  • Research Site 6

    Phoenix, Arizona 85054
    United States

    Active - Recruiting

  • Research 2

    Stanford, California 94305
    United States

    Site Not Available

  • Research Site 5

    Stanford, California 94305
    United States

    Active - Recruiting

  • Research Site 3

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Research Site 2

    Bronx, New York 10467
    United States

    Active - Recruiting

  • Research Site 5

    Bronx, New York 10467
    United States

    Site Not Available

  • Research Site 4

    New York, New York 10065
    United States

    Active - Recruiting

  • Research Site 1

    Houston, Texas 77030
    United States

    Active - Recruiting

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.