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

NCT04026100 | Unknown Phase 1

• 1 other identifier: JSPH-CTA101
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Diffuse Large B-cell Lymphoma

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity（DLT）

  Adverse events assessed according to NCI-CTCAE v4.03 criteria

  Baseline up to 35 days after T cell infusion

Secondary Outcomes (2)

• Overall response rate (ORR)

  4 weeks, 12 weeks, 6 months, 12 months, 18 months and 24 months

• Disease control rate (DCR)

  12 weeks, 6 months, 12 months, 18 months and 24 months

Study Arms (1)

CTA101

EXPERIMENTAL

Biological: CTA101

Interventions

CTA101 BIOLOGICAL

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).

CTA101

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Nanjing Bioheng Biotech Co., Ltd.: collaborator

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Lymphoma, Large B-Cell, Diffuse

Condition Hierarchy (Ancestors)

Lymphoma, B-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Jianyong Li, Ph.D.

CONTACT

025-83718836; lijianyonglm@126.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2019
• First Posted: July 19, 2019
• Study Start: December 1, 2019
• Primary Completion: August 31, 2022
• Study Completion: December 31, 2022
• Last Updated: October 31, 2019

Record last verified: 2019-10

Locations

CN (1)