Clinical trial · Interventional
CD147-CAR T Cells for Relapsed/Refractory T Cell Non-Hodgkin's Lymphoma
A Pioneering Study on the Safety and Efficacy of CD147-Chimeric Antigen Receptor (CAR) T Cells in Patients With Relapsed or Refractory T-cell Non-Hodgkin's Lymphoma
NCT05013372CI-TRIAL-00060021unknownEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The safety and preliminary effectiveness of CD147-CAR T cells in patients with relapsed or refractory T cell non-Hodgkin's lymphoma will be investigated in this pioneering study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| T-cell Non-Hodgkin's Lymphoma | T-Cell Non-Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CD147- CAR T cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Dose-escalation
- description
- Dose -1:0.1×10E+6/kg Dose 1:0.25×10E+6/kg Dose 2:0.5×10E+6/kg Dose 3:1.0×10E+6/kg Dose 4:2.0×10E+6/kg
- interventionNames
- Drug: CD147- CAR T cells
Primary outcomes (5)
- measure
- Maximum tolerated dose (MTD)
- timeFrame
- within 12 months
- description
- The highest dose that does not cause unacceptable side effects.
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- within 12 months
- description
- Side effects serious enough to prevent an increase in dose.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria:
* The subject must meet all of the following criteria:
1. 18-65 years old;
2. Relapsed or refractory T-NHLs, including peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS), angioimmunoblastic T-cell lymphoma (AITL), ALK-positive ALCL, ALK-negative Image result for anaplastic large cell lymphoma (ALCL), enteropathy-related T-cell lymphoma, hepatosplenic T-cell lymphoma, etc.;
3. Previously received ≥2 lines of treatment without a complete response;
4. Immunohistochemical detection of tumor cells CD147 positive;
5. ECOG score 0-2;
6. The collection of mononuclear cells can be performed upon the judgment of the researcher;
7. No contraindications for allogeneic hematopoietic stem cell transplantation (AlloHCT);
8. Have donors for AlloHCT;
9. Agree for sequential treatment of AlloHCT;
10. Without serious organ dysfunction in 2 weeks before CAR-T infusion:
1. Heart: without arrhythmia, LVEF≥50%, and without pericardial effusion; without heart failure (NYHA class III or IV) within12 months before CAR-T infusion; without myocardial infarction within 12 months before CAR-T infusion; without long-QT syndrome or secondary QT interval prolongation;
2. Liver: ALT\<2 times the upper limit of normal (ULN) and TBIL\<1.5 times ULN, without active hepatitis;
3. APTT and PT\<1.5 times ULN;
4. Kidney: Serum creatinine \<1.5 mg/dl; or if the serum creatinine exceeds the upper limit, eGFR (CKD-EPI formula) needs to be \> 50 ml/min;
5. Fingertip blood oxygen saturation ≥ 92%.
11. Estimated survival ≥ 3 months;
12. Sexually active patients must be willing to use an effective method of birth control during the study period and within 6 months after the study ending, and male partners should use condoms;
13. The patient is willing to join this clinical trial and sign an informed consent.
Exclusion Criteria:
* Anyone who has one or more of the following:
1. A history of other malignancies with a disease-free period \< 5 years (except for cured basal cell carcinoma of the skin, cured cervical carcinoma in situ, and gastrointestinal tumors proven to be cured by endoscopic mucosal resection);
2. Those who have received allogeneic hematopoietic stem cell transplantation or organ transplantation;
3. Patients with bone marrow involvement;
4. Those who are allergic to the biological agents in CAR-T cell product ;
5. Pregnant or breastfeeding;
6. Active bacterial, fungal or viral infection;
7. Receiving systemic hormone therapy 1 week before participating in the clinical trial;
8. Have received other gene therapy before;
9. HBV or HCV infection or carrier is defined as: HBsAg positive or HBV-DNA positive; anti-HCV positive and HCV-RNA positive;
10. Active HIV infection;
11. Clinical diagnosis of virus infection or uncontrolled virus activation, including cytomegalovirus (CMV), adenovirus (ADV), BK virus or human herpesvirus 6 (HHV-6), etc.;
12. Central nervous system lymphoma (CNSL) is defined as the presence of ≥5 tumor cells/ ul in cerebrospinal fluid (CSF) or MRI suggested CNSL; any other CNS diseases, such as uncontrolled epilepsy, cerebral ischemia/hemorrhage, dementia, cerebellar disease or any autoimmune disease involving the central nervous system, or received treatment for central nervous system or brain metastasis (radiotherapy, surgery or other treatments);
13. Imaging determined lung infection;
14. Inappropriate to participate in the trial with investigators' decision.References
Publications (0)
Data not yet available
No reference posted for this study.