Engineered immune cells take on tough blood cancers in early trial
NCT ID NCT06492304
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a new treatment called CTX131 for adults with certain blood cancers (T-cell lymphoma, B-cell lymphoma, or acute myeloid leukemia) that had returned or stopped responding to standard therapy. CTX131 uses a patient's own immune cells, modified with CRISPR gene editing, to target and attack cancer cells. The main goals were to check the treatment's safety and see if it could shrink or eliminate tumors. The trial involved 12 participants across multiple hospitals.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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12 people
The number who actually took part.
- Started
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Aug 2024
- Finished
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Mar 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 100 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 Myeloid Leukemia (AML) T cell lymphoma, including Stage ≥IIB Mycosis fungoides (MF)/ Sézary syndrome (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 T cell leukemia/lymphoma (ATLL) of leukemic, lymphomatous, and chronic unfavorable subtypes), (ALK)- ALCL after at least 1 prior line of therapy, ALK+ Anaplastic large cell lymphoma (ALCL) after at least 2 prior lines of therapy B cell lymphoma, including Diffuse large B cell lymphoma (DLBCL)-NOS, transformed marginal zone lymphoma(MZL), transformed FL, high-grade BCL with MYC and BCL2 and/or BCL6 rearrangements, Follicular lymphoma (FL) grade 3b, after at least 2 prior lines of therapy including an anti- CD20 monoclonal antibody and an anthracycline containing regimen Mantle cell lymphoma (MCL) after up to 5 prior lines of therapy which 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 line of AML therapy. APL, BCR-ABL positive leukemia, and AML secondary to prior therapy or 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) from enrollment through at least 12 months after last CTX131 infusion 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 reversible encephalopathy syndrome with prior therapy, or another condition that in opinion of investigator 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., monoclonal antibody) within 30 days prior to CTX131 infusion or with a non-biological anticancer drug within 14 days prior to CTX131 infusion. Mogamulizumab treatment is prohibited 50 days prior to CTX131 infusion. 7. Diagnosis with another invasive malignancy in the last 5 years with the exception of non- melanoma skin cancer and malignancies deemed by the investigator and medical monitor to be of low likelihood for recurrence 8. Primary immunodeficiency disorder or active autoimmune disease requiring steroids and/or other immunosuppressive therapy. 9. Prior solid organ or allogeneic BM transplantation, except for AML cohorts if at least 3 months since allogeneic HSCT, not receiving immunosuppressive therapy or donor lymphocyte infusion post SCT in the 2 weeks prior to lymphodepletion, and have no clinically active GvHD 10. Treatment with CD19-targeting CAR-T within 6 months prior to CTX131 infusion
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Research Site 1
Houston, Texas, 77030, United States
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Research Site 2
The Bronx, New York, 10467, United States
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Research Site 3
Boston, Massachusetts, 02114, United States
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Research Site 4
New York, New York, 10065, United States
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Research Site 5
Stanford, California, 94305, United States
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Research Site 6
Phoenix, Arizona, 85054, United States
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Research Site 7
East Melbourne, Victoria, 3002, Australia
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Other studies related to the condition(s) this trial covers.
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- Can a new drug pair beat standard chemotherapy for tough AML?
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