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CTA101 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04026100
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : October 31, 2019
Nanjing Bioheng Biotech Co., Ltd.
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

Brief Summary:
This is a single-center, non-randomized and dose-escalation study to evaluate the safety and efficacy of CTA101 in relapsed or refractory diffuse large B-cell lymphoma patients.

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Biological: CTA101 Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Clinical Trial of CTA101 UCART Cells Injection in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
Estimated Study Start Date : December 1, 2019
Estimated Primary Completion Date : August 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arm Intervention/treatment
Experimental: CTA101 Biological: CTA101
Universal CD19-directed CAR-T cells by a single infusion intravenously will be given in escalating doses. Subjects will been distributed into low dose (0.2×10^6), medium dose (2×10^6), and high dose (3×10^6).

Primary Outcome Measures :
  1. Dose-limiting toxicity(DLT) [ Time Frame: Baseline up to 35 days after T cell infusion ]
    Adverse events assessed according to NCI-CTCAE v4.03 criteria

Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: 4 weeks, 12 weeks, 6 months, 12 months, 18 months and 24 months ]
    Assessment of overall response rate for weeks 4, 12, months 6, 12, 18 and 24 in accordance with Lugano 2014 (overall response rate,OR)

  2. Disease control rate (DCR) [ Time Frame: 12 weeks, 6 months, 12 months, 18 months and 24 months ]
    Assessment of overall response rate for weeks 12, months 6, 12, 18 and 24 in accordance with Lugano 2014(disease control rate,DCR)

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Histologically confirmed diagnosis of DLBCL per WHO Classification Criteria for Lymphocytic Tumors 2016, including DLBCL and PMBCL transformed from follicular lymphoma;
  2. Relapsed or refractory DLBCL (meeting one of the following conditions):

    1. Recurrence, progression or stable disease (SD) after treatment with second-line or above second-line chemotherapy regimens;
    2. Recurrence or progression after autologous hematopoietic stem cell transplantation;
  3. At least one measurable lesion must be ≥ 1.5cm in the longest diameter;
  4. Male or female aged 18-70 years;
  5. Estimated survival time ≥ 12 weeks;
  6. Serum albumin ≥ 30g/L, total bilirubin ≤ 25.7umol/L, creatinine ≤ 132.6umol/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) <3 times of upper limit of normal;
  7. Absolute neutrophil count ≥ 1.0*10^9/L, platelet count ≥ 50*10^9/L;
  8. ECOG performance status 0 to 1;
  9. Echocardiographic diagnosis shows left ventricular ejection fraction (LVEF) ≥ 50%;
  10. No active infection in the lungs;
  11. Latest treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatment) must have been completed at least 2 weeks prior to screening;
  12. All women of child-bearing potential must have a negative blood or urine pregnancy test at screening, and agree to take medically acceptable contraception measures while on study treatment;
  13. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.

Exclusion Criteria:

  1. History of hypersensitivity to any component of cell product;
  2. Prior treatment with any CAR T cell product or other genetically-modified T cell therapies;
  3. Recurrence after allogeneic hematopoietic stem cell transplantation;
  4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis), or currently receiving antibiotic therapy by intravenous drip. However, prophylactic antibiotic, antiviral and antifungal treatments are allowed;
  5. HBV DNA copy number detected by PCR in patients with active hepatitis B is > 1000 at screening (if HBsAg positive, routine antiviral therapy is required after enrollment), as well as CMV, hepatitis C, syphilis and HIV infection;
  6. Patients with New York Heart Associate (NYHA) Class III/IV cardiac insufficiency (see Appendix 1);
  7. Patients with Corrected QT interval(QTc)>450 msecs (Fridericia formula);
  8. Patients with a history of epilepsy;
  9. Intracranial extranodal lesions (tumor cells in cerebrospinal fluid, and/or MRI shows intracranial lymphoma invasion);
  10. Extensive invasions of gastrointestinal lymphoma (lesions involving the muscular layer, serosa and subserosa, excluding lesions confined to the mucosa and submucosa);
  11. History of other primary cancer, except for the following conditions:

    1. Cured non-melanoma after resection, such as basal cell carcinoma of the skin
    2. Cured carcinoma in situ, such as cervical cancer, bladder cancer or breast cancer
  12. Patients with autoimmune diseases requiring treatment, patients with immunodeficiency or requiring immunosuppressive therapy;
  13. Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids;
  14. Women pregnant or lactating, with a pregnancy plan within 6 months, fertile but unable to take medically acceptable contraception measures;
  15. Patients who have participated in any other clinical studies within 2 weeks prior to screening;
  16. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04026100

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Contact: Jianyong Li, Ph.D. 025-83718836

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China, Jiangsu
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Nanjing Bioheng Biotech Co., Ltd.
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Responsible Party: The First Affiliated Hospital with Nanjing Medical University Identifier: NCT04026100    
Other Study ID Numbers: JSPH-CTA101
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: October 31, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin