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

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Brief Title

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

Official Title

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

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.
    

Detailed Description

      This study is indicated for r/r CD19+ B-ALL, the selection of dose levels and the number of
      subjects are based on clinical trial of similar foreign product, whose primary objective was
      to explore the safety, main consideration was dose-related safety.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Dose-limiting toxicity(DLT)

Secondary Outcome

 MRD negative overall response rate (MRD- ORR)

Condition

Acute Lymphoblastic Leukemia

Intervention

CTA101

Study Arms / Comparison Groups

 CTA101
Description:  Dose escalation follows the accelerated titration and the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Biological

Estimated Enrollment

15

Start Date

December 10, 2019

Completion Date

June 2022

Primary Completion Date

November 2021

Eligibility Criteria

        Inclusion Criteria:

          1. Male or female aged 3-70 years old;

          2. Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive
             Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia
             (2016.v1);

          3. Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):

               1. CR not achieved after standardized chemotherapy;

               2. CR achieved following the first induction, but CR duration is ≤ 12 months;

               3. Ineffectively after first or multiple remedial treatments;

               4. 2 or more recurrences;

          4. The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is﹥5%;

          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;

          6. 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;

          7. Echocardiogram (ECHO) shows left ventricular ejection fraction (LVEF) ≥ 50%;

          8. No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;

          9. Latest treatment (radiotherapy, chemotherapy, monoclonal antibody therapy or other
             treatment) must have been completed at least 2 weeks prior to screening;

         10. Estimated survival time ≥ 3 months;

         11. ECOG performance status 0 to 1;

         12. 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. Patients with extramedullary lesions;

          4. Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's
             leukemia/ lymphoma per WHO Classification Criteria;

          5. Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman
             syndrome or any other known bone marrow failure syndrome;

          6. Patients with New York Heart Associate (NYHA) Class III/IV cardiac insufficiency;

          7. Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or
             other severe cardiac diseases within 12 months of enrollment;

          8. Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension
             Guidelines, 1999);

          9. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular
             ischemia, and cerebrovascular hemorrhagic diseases;

         10. 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;

         11. Prior treatment with TKIs (Ph+ ALL) 1 week prior to enrollment;

         12. 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;

         13. 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;

         14. 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. Cervical cancer in situ, localized prostate cancer, ductal cancer in situ with
                  disease-free survival ≥ 2 years after adequate treatment;

         15. Patients with autoimmune diseases requiring treatment, patients with immunodeficiency
             or requiring immunosuppressive therapy;

         16. Patients with graft-versus-host disease (GVHD);

         17. If HBsAg positive at screening, HBV DNA copy number detected by PCR in patients with
             active hepatitis B > 1000 (if HBV DNA copy number≤1000, routine antiviral therapy is
             required after enrollment), as well as CMV, hepatitis C, syphilis and HIV infection;

         18. Concurrent therapy with systemic steroids within 1 week prior to screening, except for
             the patients recently or currently receiving inhaled steroids;

         19. Women pregnant or lactating, with a pregnancy plan within 6 months, fertile but unable
             to take medically acceptable contraception measures.
      

Gender

All

Ages

3 Years - 70 Years

Accepts Healthy Volunteers

No

Contacts

, 15950688971, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT04154709

Organization ID

XYFY2019-KL135-02


Responsible Party

Sponsor-Investigator

Study Sponsor

Kai Lin Xu; Jun Nian Zheng

Collaborators

 Nanjing Bioheng Biotech Co., Ltd.

Study Sponsor

, , 


Verification Date

January 2020