NCT04605666CompletedPhase 2
CD19-CAR-T2 Cells for CD19 Positive B Cell Malignancies
CD19-Chimeric Antigen Receptor-T2 Cells for CD19 Positive Relapsed/Refractory B Cell Leukemia/Lymphoma
Source: ClinicalTrials.gov · Last updated 20 Aug 2024
Brief summary (registry, in English)
Chimeric antigen receptor T cells (CAR-T cells) has been recognized a promising treatment option for treating B cell derived malignancy. The purpose of this study is to evaluate the efficacy and safety of third-generation anti-CD19 CAR T-cells (CD19-CAR-T2 Cells) in patients with CD19+ relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (B-ALL) and B-cell Non Hodgkin Lymphoma (B-NHL).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 77 (actual)
- First submitted
- 25 Oct 2020
- Start date
- 1 May 2020
- Primary completion date
- 30 Jun 2023
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Diseases
- Chronic lymphocytic leukaemia
- NCT number
- NCT04605666
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 77
- From 1 May 2020 to the primary completion date, 30 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous treatment with investigational gene or cell therapy medicine products
- Received non-diagnostic purposes major surgery within the past 4 weeks
- Used murine biological products (except blinatumomab), unless it is proved no anti-mouse antibodies exist.
- Use of prohibited drugs:
- Steroids: Therapeutic doses of steroids must be stopped \> 72 hours prior to CD19-CAR-T2 Cells infusion
- GVHD therapies: Any drug used for GVHD must be stopped \> 4 weeks prior to CD19-CAR-T2 Cells infusion
Other illness
- Active hepatitis B , hepatitis C or HIV infection
- Uncontrolled active infection
- Any uncontrolled active medical disorder that would preclude participation as outlined.
Lab values
- Allogeneic cellular therapy: Any donor lymphocyte infusions (DLI) must be completed \> 4 weeks prior to CD19-CAR-T2 Cells infusion
Other
- Presence of grade 2-4 acute or extensive chronic GVHD
- Participated in any other clinical study within the past 4 weeks
- Pregnancy or breast-feeding women
- Any situation that may increase the risk of the test or interfere with the test results
Who the study is looking for
- Patient with relapsed and/or refractory CD19+ B-cell leukemia or lymphoma
- Eastern Cooperative Oncology Group (ECOG) performance status \<2
- ALT/ AST \<3 x normal
- Bilirubin \< 2.0 mg/dl
- Creatinine \< 2.5 mg/dl and less than 2.5x normal for age
- LVEF\< 45%
- Accept white blood cell collection
- Provide informed consent
Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nanfang Hospital, Southern Medical University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.