Status:
RECRUITING
Exploratory Study of TRBC1/2-Targeted CAR-T Cell Therapy in Relapsed/Refractory Peripheral T-Cell Lymphoma
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsors:
Peking University Cancer Hospital & Institute
Ruijin Hospital
Conditions:
Refractory/Recurrent Peripheral T-cell Lymphoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This study aims to evaluate the safety and efficacy of TRBC1/2-directed chimeric antigen receptor T cells (TRBC1/2 CAR-T 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-T cell therapy in patients with TRBC1/2-positive T-cell lymphoma. The...
Eligibility Criteria
Inclusion
- 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:
- 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.
- 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-T 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.
- Exclusion Criteria
- 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.
- 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.
- Autoimmune disease requiring immunosuppressive therapy.
- Use of immunosuppressive agents or therapeutic doses of corticosteroids (defined as prednisone \>20 mg/day or equivalent) within 7 days prior to leukapheresis, or use of hematopoietic growth factors such as G-CSF. Physiological replacement therapy, topical, or inhaled corticosteroids are permitted.
- Receipt of chemotherapy, targeted therapy, immunotherapy, or radiotherapy within 3 days prior to leukapheresis.
- Participation in another clinical trial within 4 weeks or within 5 half-lives of the investigational product (whichever is shorter) prior to leukapheresis.
Exclusion
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT07164560
Start Date
September 1 2025
End Date
September 1 2028
Last Update
September 10 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
2nd Affiliated Hospital,School of Medicine,Zhejiang University
Hangzhou, Zhejiang, China