Clinical trial · Interventional
CAR T Cells Targeting CD30 Positive Lymphomas (4SCAR30273)
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Relapsed and Refractory CD30 Positive Lymphomas
- 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)
Currently, a majority of lymphomas cannot be cured by standard chemo-radiotherapy. Cluster of differentiation antigen 30 (CD30) is expressed in many lymphoma subtypes, such as Hodgkin lymphoma (HL) and anaplastic large cell lymphoma (ALCL). CD30 represents a very attractive target for chimeric antigen receptor (CAR)-based immune cell therapy. This study will evaluate a novel 4th generation CD30 CAR engineered with a self-withdrawal mechanism (FKBP-iCasp9) for both efficacy and safety evaluation in lymphoma patients.
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 |
|---|---|---|---|
| Lymphomas | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anti-CD30 CAR T cells | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CAR T cells
- description
- Autologous 4th generation anti-CD30 CAR T cells
- interventionNames
- Genetic: Anti-CD30 CAR T cells
Primary outcomes (1)
- measure
- Number of patients with adverse events.
- timeFrame
- 2 years.
- description
- Determine the toxicity profile of the 4th generation CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
Secondary outcomes (3)
- measure
- Survival time of Anti-CD30 CAR T cells in vivo.
- timeFrame
- 2 years.
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Relapsed or refractory CD30(+) lymphoma patients proved by immuno-histochemistry (IHC) or Flow-cytometry. * Not eligible for autologous stem-cell transplantation (ASCT) or relapsed after ASCT. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Age≥18. * Pulse oximetry of \> 90% on room air. * Adequate hepatic function, defined as alanine transaminase (ALT) \<3 x upper limit of normal (ULN), aspartate aminotransferase (AST) \<3 x ULN; serum bilirubin and alkaline phosphatase \<2 x ULN. * Adequate renal function, defined as serum creatinine \<2.0mg/dl. * Adequate heart function with LVEF≥50% * Hb≥80g/L * Measurable disease can be identified. * Life expectancy ≥3 months. * Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 1 year after the study is concluded. The male partner should use a condom. * Patients must sign an informed consent. Exclusion Criteria: * Uncontrolled active infection. * Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV). * HIV positive * Pregnant or lactating. * Currently enrolled in another clinical trial. * Concurrent use of systemic steroids.
References
Publications (0)
Data not yet available