Supercharged immune cells take on tough T-Cell cancers
NCT ID NCT07137481
First seen Jun 27, 2026 · Last updated Aug 21, 2026 · Updated 6 times
Summary
This Phase 2 trial tests a new treatment for aggressive T-cell blood cancers. Patients receive specially engineered natural killer (NK) cells from donated cord blood, along with chemotherapy, to try to keep the cancer in remission. The study will enroll 70 adults aged 18-80 whose tumors express a protein called CD5. The main goals are to check safety and see how long patients stay cancer-free.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- engineered natural killer (NK) cells (CD5 CAR IL-15 NK cells) plus chemotherapy drugs (fludarabine, cyclophosphamide, rituximab)
- What this could lead to
- If successful, this could offer a new consolidation therapy to keep aggressive T-cell cancers in remission longer after initial treatment.
- What could go wrong
- This is a Phase 2 trial with only 70 participants, so results are preliminary. The therapy involves strong chemotherapy and engineered cells, which may cause serious side effects like infections or organ damage.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Feb 2027
An estimate. Start dates often move.
- Expected to finish
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Jul 2032
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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 80 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. 18-80 years of age 2. Patients with hematological malignancies with an expression of CD5 in the tumor sample of ≥ 30% measured by immunohistochemistry or flow cytometry. 3. Patients must meet disease-specific eligibility criteria. a. Patients with a history of T-lymphoid malignancies, defined as T cell acute lymphoblastic leukemia/lymphoma (T-ALL/T-LBL), T-PLL, Peripheral T-cell lymphoma (PTCL-NOS), Hepatosplenic gamma/delta NHL, AITL, Alk negative/ DUSP22 negative ALCL, or other subtypes of T cell NHL with indication for autologous or allogeneic transplant in CR-1 Patients with T-ALL and T-PLL who are in morphologic remission but flow MRD positive are eligible. 4. Patients should be at least 1 week from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least three days prior to administration of lymphodepleting chemotherapy. 5. Localized radiotherapy to one or more disease sites is allowed. 6. Karnofsky Performance Scale \> 50%. 7. Adequate organ function: 1. Renal: Serum creatinine ≤ 2.0 ULN or estimated Glomerular Filtration Rate (eGFR using the CKI-EPI equation) ≥ 30 ml/min/1.73 m2. 2. Hepatic: ALT/AST ≤ 3.0 x ULN or ≤ 5 x ULN if documented liver involvement with disease, Total bilirubin ≤ 2.0 ULN, except in subjects with Gilbert's Syndrome in whom total bilirubin must be ≤ 3.0 mg/dL. No history of liver cirrhosis. 3. Cardiac: Cardiac ejection fraction ≥ 40%, no clinically significant pericardial effusion as determined by an ECHO or MUGA, and no uncontrolled arrhythmias or symptomatic cardiac disease. 4. Pulmonary: No clinically significant lung involvement, per PI discretion, pleural effusion, baseline oxygen saturation \> 92% on room air. 8. Ability to understand and the willingness to sign a written informed consent document. 9. Weight ≥40 kg. 10. English and non-English-speaking patients are eligible. 11. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (Refer to Pregnancy Assessment Policy MD Anderson Institutional Policy # CLN1114). This includes all female patients, between the onset of menses (as early as 8 years of age) and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following: * Postmenopausal (no menses in greater than or equal to 12 consecutive months). * History of hysterectomy or bilateral salpingo-oophorectomy. * Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy). * History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 3 months after completion of study therapy. 12. Signed consent to long-term follow-up protocol PA17-0483. Exclusion Criteria: 1. Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females. 2. Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI. 3. Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy. 4. Active hepatitis B or C. 5. HIV with detectable viral load. 6. Presence of active neurological disorder(s). 7. Active autoimmune disease within 12 months of enrollment 8. Active cerebral or meningeal involvement by the malignancy 9. Active (defined as requiring therapy) acute or chronic GVHD. 10. Any other malignancy known to be active, except for treated cervical intra-epithelial neoplasia and non-melanoma skin cancer. 11. Presence of any other serious medical condition that may endanger the patient at the investigator criteria. 12. Major surgery \<4 weeks prior to first dose of study drug 13. Allogeneic SCT or DLI \<12 weeks prior to first dose of study drug. Recipients of an allogeneic SCT patients should have discontinued all forms of immunosuppression at least 8 weeks prior to enrollment in the study. 14. Concomitant use of other investigational agents. 15. Concomitant use of other anti-cancer agents. 16. Patients receiving systemic steroid therapy at the time of NK cell infusion (physiological substitutive doses are allowed) or have received ATG or lymphocyte immune globulin within 14 days or alemtuzumab within 3 months of enrollment. 17. Patients receiving immunosuppressive therapy. 18. Patients with diminished mental capacity will not be enrolled in the study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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The University of Texas M. D. Anderson Cancer Center
Houston, Texas, 77030, United States
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