Status:
UNKNOWN
CTA101 in the Treatment of Relapsed or Refractory Diffuse Large B-cell Lymphoma
Lead Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Collaborating Sponsors:
Nanjing Bioheng Biotech Co., Ltd.
Conditions:
Diffuse Large B-cell Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
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.
Eligibility Criteria
Inclusion
- Histologically confirmed diagnosis of DLBCL per WHO Classification Criteria for Lymphocytic Tumors 2016, including DLBCL and PMBCL transformed from follicular lymphoma;
- Relapsed or refractory DLBCL (meeting one of the following conditions):
- Recurrence, progression or stable disease (SD) after treatment with second-line or above second-line chemotherapy regimens;
- Recurrence or progression after autologous hematopoietic stem cell transplantation;
- At least one measurable lesion must be ≥ 1.5cm in the longest diameter;
- Male or female aged 18-70 years;
- Estimated survival time ≥ 12 weeks;
- 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;
- Absolute neutrophil count ≥ 1.0\*10\^9/L, platelet count ≥ 50\*10\^9/L;
- ECOG performance status 0 to 1;
- Echocardiographic diagnosis shows left ventricular ejection fraction (LVEF) ≥ 50%;
- No active infection in the lungs;
- Latest treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatment) must have been completed at least 2 weeks prior to screening;
- 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;
- Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion
- History of hypersensitivity to any component of cell product;
- Prior treatment with any CAR T cell product or other genetically-modified T cell therapies;
- Recurrence after allogeneic hematopoietic stem cell transplantation;
- 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;
- 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;
- Patients with New York Heart Associate (NYHA) Class III/IV cardiac insufficiency (see Appendix 1);
- Patients with Corrected QT interval(QTc)\>450 msecs (Fridericia formula);
- Patients with a history of epilepsy;
- Intracranial extranodal lesions (tumor cells in cerebrospinal fluid, and/or MRI shows intracranial lymphoma invasion);
- Extensive invasions of gastrointestinal lymphoma (lesions involving the muscular layer, serosa and subserosa, excluding lesions confined to the mucosa and submucosa);
- History of other primary cancer, except for the following conditions:
- Cured non-melanoma after resection, such as basal cell carcinoma of the skin
- Cured carcinoma in situ, such as cervical cancer, bladder cancer or breast cancer
- Patients with autoimmune diseases requiring treatment, patients with immunodeficiency or requiring immunosuppressive therapy;
- Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids;
- Women pregnant or lactating, with a pregnancy plan within 6 months, fertile but unable to take medically acceptable contraception measures;
- Patients who have participated in any other clinical studies within 2 weeks prior to screening;
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2022
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT04026100
Start Date
December 1 2019
End Date
December 31 2022
Last Update
October 31 2019
Active Locations (1)
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1
the First Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000