Clinical trial · Interventional
Immunotherapy With CD19 CAR T-cells in Patients With Relapsed or Refractory CD19+ Leukemia and Lymphoma
- 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)
B cell malignancies comprise a heterogeneous group of neoplasms including a vast majority of non-Hodgkin's lymphomas (NHL), lymphoblastic leukemias (ALL) and chronic lymphocytic leukemias (CLL). Current treatments for B cell malignancies include chemotherapy, radiation therapy, bone marrow transplantation, and peripheral blood stem cell transplantation. Despite these treatment modalities, most patients will remain incurable. Welgenaleucel (UWC19) is a CD19-directed genetically-modified autologous immunotherapy. This study is designed to evaluate safety and feasibility of administering Welgenaleucel (UWC19) transduced with anti-CD19 lentiviral vector to patients with advanced refractory hematologic malignancies, including DLBCL and ALL.
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 |
|---|---|---|---|
| Lymphoma Leukemia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Welgenaleucel | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Welgenaleucel (UWC19)
- description
- The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form：injection Dosage: 100mL in total Frequency:the first day, the second day, the third day Duration:total three times
- interventionNames
- Genetic: Welgenaleucel
Primary outcomes (1)
- measure
- The adverse events associated with CAR T cell product infusions are assessed.
- timeFrame
- 30 days
- description
- The type, frequency, severity, and duration of adverse events will be summarized
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * CD19+ leukemia or lymphoma patients with no available curative treatment options who have limited prognosis with currently available therapies * Absolute lymphocyte count, ALC )≧600/μl * HIV, HTLV, Syphilis negative * GPT ≦200 U/L * Cr ≦221 umol/L * Adequate venous access for apheresis, and no other contraindications for leukapheresis. * Voluntary informed consent is given. Exclusion Criteria: * Body weight \< 20Kg * Pregnant women. * Uncontrolled active infection. * Active hepatitis B or hepatitis C infection. * Concurrent use of systemic steroids. Recent or current use of inhaled steroids is not exclusionary. * Previously treatment with any gene or cell therapy products. * Any uncontrolled active medical disorder that would preclude participation as outlined. * Expected survival\< 12 weeks * Received investigational drug or device within 30 days pre-trial; * Patients with any other serious diseases considered by the investigator(s) not in the condition to enter the trial.
References
Publications (0)
Data not yet available