CTA101 UCAR-T Cell Injection for Treatment of Relapsed or Refractory CD19+ B-cell Acute Lymphoblastic Leukemia

NCT04154709 | Unknown Phase 1 DMC

• 1 other identifier: XYFY2019-KL135-02
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the safety and feasibility of CTA101 in treating patients with relapsed or refractory CD19+ B-cell acute lymphoblastic leukemia.

Conditions

Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Dose-limiting toxicity（DLT）

  Adverse events assessed according to NCI-CTCAE v5.0 criteria

  Baseline up to 28 days after T cell infusion

Secondary Outcomes (4)

• MRD negative overall response rate (MRD- ORR)

  3 months

• Overall response rate (ORR)

  Month 6, 12, 18 and 24

• Event-free survival (EFS)

  Month 6, 12, 18 and 24

• Overall survival (OS)

  Month 6, 12, 18 and 24

Study Arms (1)

CTA101

EXPERIMENTAL

Dose escalation follows the accelerated titration and the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Biological: CTA101

Interventions

CTA101 BIOLOGICAL

Universal CD19-directed CAR-T cells by a single infusion intravenously will be given in escalating doses.

CTA101

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 3-70 years old;
• Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
• Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
• CR not achieved after standardized chemotherapy;
• CR achieved following the first induction, but CR duration is ≤ 12 months;
• Ineffectively after first or multiple remedial treatments;
• or more recurrences;
• The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is﹥5%;
• Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
• Serum albumin ≥ 30g/L, total bilirubin ≤ 25.7umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8umol/L, platelet count ≥ 50\*10\^9/L;
• Echocardiogram (ECHO) shows left ventricular ejection fraction (LVEF) ≥ 50%;
• No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
• Latest treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other treatment) must have been completed at least 2 weeks prior to screening;
• Estimated survival time ≥ 3 months;
• ECOG performance status 0 to 1;

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;
• Patients with extramedullary lesions;
• Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/ lymphoma per WHO Classification Criteria;
• Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome;
• Patients with New York Heart Associate (NYHA) Class III/IV cardiac insufficiency;
• Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment;
• Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension Guidelines, 1999);
• History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
• Central nervous system leukemia (CNS2 or CNS3), resistant to intrathecal injecting of chemotherapeutic drugs, and/or undergoing skull and/or spine radiotherapy; patients with history of CNS but effectively controlled to allow enrollment;
• Prior treatment with TKIs (Ph+ ALL) 1 week prior to enrollment;
• Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis), or currently receiving antibiotic therapy by intravenous infusion, or have received antibiotic treatment by intravenous infusion within 1 week before cell infusion. However, prophylactic antibiotic, antiviral and antifungal treatments are allowed;
• Indwelling catheters in vivo (e.g. percutaneous nephrostomy, Foley catheter, bile duct catheter, or pleural/peritoneal/pericardial catheter). Ommaya storage, dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are allowed;
• History of other primary cancer, except for the following conditions:
• Cured non-melanoma after resection, such as basal cell carcinoma of the skin;

Sponsors & Collaborators

• Kai Lin Xu; Jun Nian Zheng: lead
• Nanjing Bioheng Biotech Co., Ltd.: collaborator

Study Sites (1)

Affiliated hospital of Xuzhou medical college

Xuzhou, Jiangsu, 221000, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Li Zhenyu, Ph.D

CONTACT

15950688971; lizhenyumd@163.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 INVESTIGATOR
• PI Title: President

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 6, 2019
• Study Start: December 10, 2019
• Primary Completion: November 1, 2021
• Study Completion: June 1, 2022
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)