Refractory/Recurrent Peripheral T-cell LymphomaPhase 1NCT07164560
Exploratory Study of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 for Relapsed/Refractory T-Cell Lymphoma
A Phase 1 study testing Anti-TRBC1 CAR-T cells in people with Refractory/Recurrent Peripheral T-cell Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study aims to evaluate the safety and efficacy of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 (TRBC1/2 CAR-NK cells) in patients with refractory or relapsed peripheral T-cell lymphoma (PTCL). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Refractory/Recurrent Peripheral T-cell Lymphoma
- What is being tested?
- Anti-TRBC1 CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 1 Apr 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- According to the 2016 WHO classification of lymphoid neoplasms, patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) must meet the following criteria to be eligible for enrollment:
- Voluntarily agree to participate in this study and provide signed informed consent.
- Age 18 to 75 years, male or female.
- Diagnosis of relapsed/refractory PTCL, defined as failure of ≥1 prior line of therapy. Eligible histologic subtypes include (but are not limited to):
- Angioimmunoblastic T-cell lymphoma (AITL) Anaplastic large cell lymphoma (ALCL) Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)
- Estimated life expectancy ≥12 weeks.
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- TRBC1/2-positive tumor tissue (≥20% by immunohistochemistry) OR TCR gene rearrangement confirmed by PCR or NGS.
- ECOG performance status of 0-2.
- Adequate organ function as defined below:
- ALT and AST ≤ 2.5 × upper limit of normal (ULN) Creatinine clearance (Cockcroft-Gault) ≥ 60 mL/min Total bilirubin ≤ 1.5 × ULN Left ventricular ejection fraction (LVEF) ≥ 50% Baseline oxygen saturation > 92% on room air
- Hematology:
- Phase Ia: ANC > 1500/mm³, platelets > 75 × 10⁹/L, hemoglobin > 9 g/dL Phase Ib: ANC > 1000/mm³, platelets > 50 × 10⁹/L, hemoglobin > 8 g/dL
- ≥3 months since prior autologous hematopoietic stem cell transplantation.
- Prior CAR-NK therapy targeting a different antigen is permitted if lack of efficacy was confirmed after ≥3 months of evaluation, or if complete remission (CR) was achieved but relapse occurred.
- Women of childbearing potential must have a negative pregnancy test prior to enrollment. All patients (male and female) must agree to use effective contraception during the study.
- Presence of at least one measurable lesion.
- All approved prior anti-tumor therapies (including systemic chemotherapy, total body irradiation, or immunotherapy) must have been completed ≥3 weeks before study drug administration; for non-chemotherapy targeted agents, a washout period of ≥2 weeks is required.
Who cannot join
- Patients meeting any of the following criteria will be excluded from this study:
- History of allergy to any component of the cell product.
- History of another malignancy that has not achieved remission.
- Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- Receipt of gene therapy within the past 3 months.
- Uncontrolled systemic active infection (with the exception of simple urinary tract infection or bacterial pharyngitis). Prophylactic use of antibiotics, antivirals, or antifungal agents is permitted.
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- Active hepatitis B infection (HBsAg positive; however, patients with HBV-DNA <10³ copies/mL are not excluded), active hepatitis C virus infection (including carriers), syphilis, or other acquired or congenital immunodeficiency diseases, including but not limited to HIV infection.
- New York Heart Association (NYHA) Class III or IV heart failure.
- Unresolved toxicity from prior anti-tumor therapy (defined as CTCAE v5.0 Grade >1, with the exception of fatigue, anorexia, and alopecia).
- Evidence of central nervous system (CNS) involvement at screening, or clinically significant CNS disease such as a history of seizures or other CNS disorders.
- Prior exposure to any agent specifically targeting TRBC1/2.
- Lactating women who are unwilling to discontinue breastfeeding.
- Any other condition that, in the opinion of the investigator, may increase patient risk or interfere with the study results.
- People who test positive for COVID-19 or influenza A virus.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital,School of Medicine,Zhejiang University
Hangzhou, Zhejiang
Wenbin Qian, +87-57189713672, qianwb@zju.edu.cn
About this study
Official title: Clinical Study of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 for Relapsed/Refractory T-Cell Lymphoma
This study aims to evaluate the safety and efficacy of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 (TRBC1/2 CAR-NK cells) in patients with refractory or relapsed peripheral T-cell lymphoma (PTCL).
Read the detailed description
This is a multicenter, open-label, single-arm, phase I clinical trial designed to evaluate the safety and efficacy of TRBC1/2 CAR-NK cell therapy in patients with TRBC1/2-positive T-cell lymphoma.
The study will be conducted in two parts:
Phase I (Dose Escalation):
A dose-escalation study will be carried out following the conventional "3+3" design, with one dose level administered via intravenous infusion. Each cohort will enroll 3 to 6 patients. After the initial infusion, patients will be observed for at least 28 days for safety evaluation, followed by long-term follow-up of up to 2 years post-infusion.
Phase II (Dose Expansion):
Based on safety, in vivo expansion and persistence of TRBC1/2 CAR-NK cells, and preliminary efficacy results from Phase I, the recommended dose and administration schedule will be determined. Approximately 30 eligible patients will then be enrolled to further assess safety and efficacy at the selected dose. Following the first infusion of TRBC1/2 CAR-NK cells, patients will continue in long-term follow-up for up to 2 years.
- Being tested
- Anti-TRBC1 CAR-T cells
- Keywords
- Refractory/recurrent, Peripheral T-cell lymphoma, TRBC1/2 CAR-NK
- Medical subject headings
- Lymphoma, T-Cell, Peripheral, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-TRBC1 CAR-T cellsBiological
Umbilical cord blood-derived NK cells transduced with lentiviral vector express anti-TRBC1 CAR
| Study group | Role | What they receive |
|---|---|---|
| CB TRBC1/2 CAR-NK | Experimental | Not described Receives: Biological: Anti-TRBC1 CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicity (DLTs)
To evaluate the safety, tolerability, and determine the recommended dosage of peripheral blood-derived Anti-TRBC1/2 CAR-T Cell Therapy for refractory/relapsed peripheral T-cell lymphoma.
Measured: Up to 28 days
Secondary outcomes (1)
Complete response rate (CR)
To determine the anti-tumor effectivity of PB TRBC1/2 CAR-T
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start1 Apr 2026 (estimated)
- Primary completion1 Jan 2029 (estimated)
- Study completion1 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Refractory/Recurrent Peripheral T-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164560
- Sponsor's protocol ID
- 2025-0638
- Status last verified
- Mar 2026
- First submitted
- 2 Sep 2025
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 for Relapsed/Refractory T-Cell Lymphoma
- ClinicalTrials.gov ID
- NCT07164560
- Acronym / sponsor ID
- 2025-0638
- Keywords
- Refractory/recurrent, Peripheral T-cell lymphoma, TRBC1/2 CAR-NK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Jan 2029 (estimated)
- Study completion
- 1 Apr 2029 (estimated)
- First posted
- 10 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to evaluate the safety and efficacy of Umbilical Cord Blood-Derived CAR-NK Cell Therapy Targeting TRBC1/2 (TRBC1/2 CAR-NK cells) in patients with refractory or relapsed peripheral T-cell lymphoma (PTCL).
Detailed description
This is a multicenter, open-label, single-arm, phase I clinical trial designed to evaluate the safety and efficacy of TRBC1/2 CAR-NK cell therapy in patients with TRBC1/2-positive T-cell lymphoma.
The study will be conducted in two parts:
Phase I (Dose Escalation):
A dose-escalation study will be carried out following the conventional "3+3" design, with one dose level administered via intravenous infusion. Each cohort will enroll 3 to 6 patients. After the initial infusion, patients will be observed for at least 28 days for safety evaluation, followed by long-term follow-up of up to 2 years post-infusion.
Phase II (Dose Expansion):
Based on safety, in vivo expansion and persistence of TRBC1/2 CAR-NK cells, and preliminary efficacy results from Phase I, the recommended dose and administration schedule will be determined. Approximately 30 eligible patients will then be enrolled to further assess safety and efficacy at the selected dose. Following the first infusion of TRBC1/2 CAR-NK cells, patients will continue in long-term follow-up for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CB TRBC1/2 CAR-NK | Experimental | Biological: Anti-TRBC1 CAR-T cells |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- According to the 2016 WHO classification of lymphoid neoplasms, patients with relapsed/refractory peripheral T-cell lymphoma (PTCL) must meet the following criteria to be eligible for enrollment:
- Voluntarily agree to participate in this study and provide signed informed consent.
- Age 18 to 75 years, male or female.
- Diagnosis of relapsed/refractory PTCL, defined as failure of ≥1 prior line of therapy. Eligible histologic subtypes include (but are not limited to):
- Angioimmunoblastic T-cell lymphoma (AITL) Anaplastic large cell lymphoma (ALCL) Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)
Key exclusion criteria (14 listed)
- History of allergy to any component of the cell product.
- History of another malignancy that has not achieved remission.
- Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
- Receipt of gene therapy within the past 3 months.
- Uncontrolled systemic active infection (with the exception of simple urinary tract infection or bacterial pharyngitis). Prophylactic use of antibiotics, antivirals, or antifungal agents is permitted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti-TRBC1 CAR-T cellsUmbilical cord blood-derived NK cells transduced with lentiviral vector express anti-TRBC1 CAR | Biological | CB TRBC1/2 CAR-NK |
Primary outcome
Incidence of dose limiting toxicity (DLTs)
Time frame: Up to 28 days
To evaluate the safety, tolerability, and determine the recommended dosage of peripheral blood-derived Anti-TRBC1/2 CAR-T Cell Therapy for refractory/relapsed peripheral T-cell lymphoma.
1 secondary outcome
Complete response rate (CR)
Time frame: 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Anti-TRBC1 CAR-T cells in people with Refractory/Recurrent Peripheral T-cell Lymphoma, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenbin Qian, professor (87-57189713672, Qianwb@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicity (DLTs) (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.