Phase
Condition
Lymphoma
Non-hodgkin's Lymphoma
Lymphoma, B-cell
Treatment
CTX131
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
≥18 years of age
Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 (ECOG status of 2 will be permitted for subjects with AML)
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.
Adequate renal, liver, cardiac and pulmonary organ function
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:
Prior treatment with anti-CD70 targeting agents
Active CNS manifestation of underlying disease
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
Uncontrolled bacterial, viral, or fungal infection
Positive for HIV, or active hepatitis B virus or hepatitis C virus infection.
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.
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
Primary immunodeficiency disorder or active autoimmune disease requiring steroidsand/or other immunosuppressive therapy.
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
Treatment with CD19-targeting CAR-T within 6 months prior to CTX131 infusion
Study Design
Study Description
Connect with a study center
Research Site 7
East Melbourne, Victoria 3002
AustraliaActive - Recruiting
Research Site 6
Phoenix, Arizona 85054
United StatesActive - Recruiting
Research 2
Stanford, California 94305
United StatesSite Not Available
Research Site 5
Stanford, California 94305
United StatesActive - Recruiting
Research Site 3
Boston, Massachusetts 02114
United StatesActive - Recruiting
Research Site 2
Bronx, New York 10467
United StatesActive - Recruiting
Research Site 5
Bronx, New York 10467
United StatesSite Not Available
Research Site 4
New York, New York 10065
United StatesActive - Recruiting
Research Site 1
Houston, Texas 77030
United StatesActive - Recruiting

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