Clinical trial · Interventional
CD30 CAR-T in the Treatment of CD30 Positive Lymphoma
Clinical Study on the Safety and Efficacy of Chimeric Antigen Receptor Gene Modified T Cells Targeting CD30 in the Treatment of CD30 Positive Relapsed/Refractory Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 29, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260929-000001
Why stopped (as posted): Because of changes in domestic regulations, we need to complete the local filing process first before continuing the research.
Summary
Brief summary (as posted)
The is a prospective, open-label, dose-climbing multicenter clinical study assessing the efficacy and safety of CD30 CAR-T in the treatment of r/r CD30+ lymphoma. Plan to recruit 15 subjects with r/r CD30+ lymphoma。
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| B Cell Lymphoma | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
| CD30+ Peripheral T-cell Lymphoma | — | UNRESOLVED | — |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chimeric antigen receptor gene modified T cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- low-dose group
- description
- Subjects received a single low-dose CD30 CAR-T therapy
- interventionNames
- Drug: chimeric antigen receptor gene modified T cells
- type
- EXPERIMENTAL
- label
- medium-dose group
- description
- Subjects received a single medium-dose CD30 CAR-T therapy
- interventionNames
- Drug: chimeric antigen receptor gene modified T cells
- type
- EXPERIMENTAL
- label
- High-dose group
- description
- Subjects received a single high-dose CD30 CAR-T therapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Age≥18 years and ≤65years,female and male; * CD30+ recurrent/refractory malignant hematological malignancies, experienced recurrence (disease progression after treatment remission) or refractory (previous systemic treatment did not achieve CR) after ≥ 2-line systemic treatment; * CD30 expression \>10% by immunohistochemistry; * At least 1 measurable lesion can be measured according to theLugano 2014 evaluation criteria; * The estimated survival time ≥3 months; * ECOG performance status 0-2,KPS\>60%; * Sufficient organ function:ALT,AST≤2.5×ULN,patients with liver invasion can be relaxed to ≤ 5 x ULN;serum total bilirubin\<34 μmol/L;creatinine clearance rate\>30 mL/min;EF≥40%;No pericardial effusion and obvious arrhythmia;SpO2≥92%; * ALC ≥0.5×109/L,PLT\>30×109/L,Hb\>80 g/L and subjects had apheresis venous access and no contraindications for blood cell separation; * MRI showed no central involvement of lymphoma; * Patients with fertility must be willing to be able to use reliable contraceptive measures ; * The subject or legal guardian can understand and voluntarily sign the written informed consent. Exclusion Criteria: * Lymphoma-associated hemophagic cell syndrome; * Pregnant or lactating women, and women who have a pregnancy plan within six months; * Hepatitis B(HBsAg、HBsAb、HBeAg、HBeAb、HBcAb),Hepatitis C(Anti-HCV),Anti-HIV Ⅰ/Ⅱ and anti-TP positive(Hepatitis B DNA test is negative except); * Suffered from other malignant tumors, except for for skin basal cell carcinoma, skin squamous cell carcinoma and cervical carcinoma in situ undergoing the radical treatment; * Received Anti-CD30 Ab therapy within 4 weeks before enrollment; * Unresolved \> Grade 1 non-hematologic toxicity associated with any prior treatments; * Active uncontrolled bleeding or a known bleeding diathesis; * Autologous hematopoietic stem cell transplantation was performed within 6 weeks; * Uncontrollable active bacterial or fungal infection; * Known allergy to the study drug and its components; * Suffer from active autoimmune diseases that require systemic treatment ; * Persons with mental or mental illness who cannot cooperate with treatment and efficacy evaluation; * Participated in other clinical studies within 1 months prior to this study; * History of allogeneic hematopoietic stem cell transplantation; * patients with any condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject.
References
Publications (0)
Data not yet available