XLCART001 Treatment in Relapsed/Refractory/High-risk B-cell Malignancy Subjects

NCT03598179 | Unknown Phase 2

• 1 other identifier: JSPH-CART001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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

Lymphoma, B-Cell; Leukemia, B-cell

Outcome Measures

Primary Outcomes (4)

• Overall response rate

  Overall response rate (ORR) = complete response (CR) rate + partial response (PR) rate, ORR will be assessed at weeks 12.

  12 weeks

• Overall Survival

  from the time of enrollment to death from any cause or the date of the last follow-up visit

  6 months,1 year, 2 years

• Progression-free Survival

  the time from enrollment to disease progression, death from any cause, or the date of the last follow-up visit

  12 weeks,6 months,1 year, 2 years

• Event-free Survival

  the time from enrollment to any events, or the date of the last follow-up visit

  12 weeks,6 months,1 year, 2 years

Secondary Outcomes (3)

• Dose-limiting toxicity (DLT)

  28 days

• Number of CAR-T cells

  Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years

• Duration of CAR-T cells

  Day 1, Day 4, Day 7, Day 10, Day 14, Day 21, Day 28, 8 weeks, 12 weeks, 6 months, 1 years, 2 years

Interventions

chimeric antigen receptor T cells BIOLOGICAL

Dose CAR+ cells/kg B-cell lymphoma 4×10\^6 Acute lymphocytic leukemia 2×10\^6 Chronic lymphocytic leukemia 10×10\^6

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

Department of Haematology, the First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital

Nanjin, Jiangsu, 210029, China

Location

Related Publications (1)

• Ernst 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 DERIVED

MeSH Terms

Conditions

Lymphoma, B-Cell; Leukemia, B-Cell

Interventions

Immunotherapy, Adoptive

Condition Hierarchy (Ancestors)

Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Lymphoid; Leukemia; Hematologic Diseases

Intervention Hierarchy (Ancestors)

Adoptive Transfer; Immunization, Passive; Immunization; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 26, 2018
• Study Start: June 1, 2018
• Primary Completion: December 30, 2019
• Study Completion: July 1, 2020
• Last Updated: August 7, 2019

Record last verified: 2019-08

Locations

CN (1)