Umbilical cord blood CAR‑NK cells targeting TRBC1/2 for relapsed or refractory peripheral T‑cell lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open‑label, single‑arm Phase I study using umbilical cord blood‑derived CAR‑NK cells directed at TRBC1/2 in patients with relapsed or refractory peripheral T‑cell lymphoma. Phase I uses a conventional 3+3 dose‑escalation design with one intravenous dose level and 28‑day safety observation, followed by long‑term follow‑up up to 2 years. If safety, in vivo expansion/persistence, and early efficacy are acceptable, a dose‑expansion cohort of about 30 patients will be enrolled to further characterize safety and preliminary efficacy. The trial requires documented TRBC1/2 positivity by IHC or TCR gene rearrangement and monitors organ function and performance status throughout.

Why it matters

Who can join: the full rules

Inclusion Criteria

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:

1. Voluntarily agree to participate in this study and provide signed informed consent.
2. Age 18 to 75 years, male or female.
3. 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)
4. Estimated life expectancy ≥12 weeks.
5. TRBC1/2-positive tumor tissue (≥20% by immunohistochemistry) OR TCR gene rearrangement confirmed by PCR or NGS.
6. ECOG performance status of 0-2.
7. 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
8. ≥3 months since prior autologous hematopoietic stem cell transplantation.
9. 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.
10. 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.
11. Presence of at least one measurable lesion.
12. 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.

Exclusion Criteria

Patients meeting any of the following criteria will be excluded from this study:

1. History of allergy to any component of the cell product.
2. History of another malignancy that has not achieved remission.
3. Prior allogeneic hematopoietic stem cell transplantation or solid organ transplantation.
4. Receipt of gene therapy within the past 3 months.
5. 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.
6. 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.
7. New York Heart Association (NYHA) Class III or IV heart failure.
8. Unresolved toxicity from prior anti-tumor therapy (defined as CTCAE v5.0 Grade \>1, with the exception of fatigue, anorexia, and alopecia).
9. Evidence of central nervous system (CNS) involvement at screening, or clinically significant CNS disease such as a history of seizures or other CNS disorders.
10. Prior exposure to any agent specifically targeting TRBC1/2.
11. Lactating women who are unwilling to discontinue breastfeeding.
12. Any other condition that, in the opinion of the investigator, may increase patient risk or interfere with the study results.
13. People who test positive for COVID-19 or influenza A virus.

Where it's running

• 2nd Affiliated Hospital,School of Medicine,Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Wenbin Qian, professor
• Email: Qianwb@zju.edu.cn
• Phone: 87-57189713672

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.