Clinical trial · Interventional
XLCART001 Treatment in Relapsed/Refractory/High-risk B-cell Malignancy Subjects
A Single-center, Open Study Evaluating Efficacy and Safety of XLCART001(CD-19) Treatment in Relapsed/Refractory/High-risk B-cell Malignancy Subjects
NCT03598179CI-TRIAL-00039921unknownPhase 2ClinicalTrials.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 trial is a single arm, single-center, non-randomized clinical trial which is designed to evaluate the efficacy and safety of XLCART001 in treatment of relapsed/refractory/high-risk B-cell malignancy subjects
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia, B-cell | Leukemia | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, B-Cell | B-Cell Malignant Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| chimeric antigen receptor T cells | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Overall response rate
- timeFrame
- 12 weeks
- description
- Overall response rate (ORR) = complete response (CR) rate + partial response (PR) rate, ORR will be assessed at weeks 12.
- measure
- Overall Survival
- timeFrame
- 6 months,1 year, 2 years
- description
- from the time of enrollment to death from any cause or the date of the last follow-up visit
- measure
- Progression-free Survival
- timeFrame
- 12 weeks,6 months,1 year, 2 years
- description
- the time from enrollment to disease progression, death from any cause, or the date of the last follow-up visit
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥18 years, male and female, * Confirmed as CD19-positive B cell lymphoma/leukemia by immunohistochemistry or flow cytometry * No effective treatment * Patients must have a measurable or evaluable disease at the time of enrollment. * Adequate organ system function including: * ALT/AST \< 3 upper limit of normal; Total Bilirubin \< 2.5 upper limit of normal * Creatinine \< 2 upper limit of normal * Oxygen saturation ≥ 95% * Left ventricular ejection fraction ≥ 40% * Number of neutrophil ≥ 0.75×10\^9/L, number of platelet ≥ 50×10\^9/L * At least 4 weeks from receiving previous treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatments) * No contraindications of peripheral blood apheresis * Female subjects in childbearing age, their serum or urine pregnancy test must be negative. All patients must agree to take effective contraceptive measures during the trial measures * ECOG score 0-2, expected survival ≥ 12 weeks Exclusion Criteria: * Women who are pregnant or lactating. Patients have breeding intent in 12 months or cannot take effective contraceptive measures during the trial measures * Uncontrollable active infection within four week. Prophylactic antibiotic, antiviral and antifungal treatment is permissible. Active hepatitis B or hepatitis C virus infection, as well as acquired, congenital immune deficiency diseases, including but not limited to HIV-infected persons * Subjects with any autoimmune disease or any immune deficiency disease * Have a history of allergy to antibodies or cellular products * Participated in any other clinical trial within four weeks * Used of systemic steroids within four weeks (using inhaled steroids or ≤ 20mg/d prednison are exceptions) * Have mental diseases * Have history of drug addiction * The investigators believe that any increase in the risk of the subject or interference with the results of the trial
References
Publications (1)
- DERIVEDErnst M, Oeser A, Besiroglu B, Caro-Valenzuela J, Abd El Aziz M, Monsef I, Borchmann P, Estcourt LJ, Skoetz N, Goldkuhle M. Chimeric antigen receptor (CAR) T-cell therapy for people with relapsed or refractory diffuse large B-cell lymphoma. Cochrane Database Syst Rev. 2021 Sep 13;9(9):CD013365. doi: 10.1002/14651858.CD013365.pub2. PMID 34515338