CD19-Synthetic T Cell Antigen Receptor(STAR)-T in B-cell Malignancies Patients

NCT03953599 | Completed Phase 1 DMC

• 1 other identifier: HXYT-003
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, single arm, open-lable phase I study to determine the safety and efficacy of CD19-STAR-T cells in patients with refractory and relapsed B-cell malignancies (such as NHL and ALL ).

Conditions

B Cell Malignancy

Outcome Measures

Primary Outcomes (2)

• Percentage of adverse events

  Percentage of participants with adverse events.

  6 months

• Objective Remission Rate(ORR)

  The percentage of participants who achieved complete remission (CR) and partial remission over all participants.

  6 months

Secondary Outcomes (3)

• Relapse-Free Survival(RFS )

  6 months

• Overall-Survival(OS)

  6 months

• Persistence of STAR-T cells in vivo

  6 months

Study Arms (1)

CD19-STAR-T cells

EXPERIMENTAL

CD19-STAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of STAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.

Biological: CD19-STAR-T cells

Interventions

CD19-STAR-T cells BIOLOGICAL

CD19-STAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of STAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.

CD19-STAR-T cells

Eligibility Criteria

• Age: 1 Year - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Relapsed and refractory CD19 positive B-cell acute malignancies with:
• Relapsed after competed remission, could not get competed remission after at more than 1 course of chemotherapy (including MRD≥0.1%);
• MRD≥0.1% after allogeneic hematopoietic stem cell transplantation(HSCT), or recurrence after complete remission or MRD ≥ 0.1% after HSCT;
• Refractory: at least two courses of chemotherapy did not achieve complete remission or MRD ≥ 0.1%;
• Patients must have evaluable evidence of disease, including minimal residual disease (MRD);
• Ph + patients who meet the following criteria can register:Failure to tolerate TKI or TKI treatment failure, or failure to transplant;
• Ages 1 to 70 years, including boundary values;
• ECOG score 0-3 points;
• Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside.

You may not qualify if:

• patients with organ failure:
• Heart: NYHA heart function grade III or IV ;
• Liver: Grade C that achieves Child-Turcotte liver function grading;
• Kidney: kidney failure and uremia;
• Lung: symptoms of respiratory failure;
• Brain: a person with a disability;
• Active infections that are difficult to control;
• Human immunodeficiency virus (HIV) positive;
• Liver and kidney function: total bilirubin \> 5 × ULN, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \> 5 × ULN, serum creatinine clearance rate 60mL / min;
• GVHD ≥ 2 or receiving anti-GVHD treatment;
• Received allogeneic cell therapy within 4 weeks, such as donor lymphocyte infusion(DLI);
• Subject received anti-tumor treatment (chemotherapy, mAb, or hormone) for less than 1 week;
• Central nervous system leukemias that is symptomatic or uncontrolled by systemic chemotherapy and intrathecal chemotherapy (a large number of tumor cells in CSF, white blood cell count \>15WBCs/mL);
• intracranial hypertension or unconsciousness; respiratory failure; diffuse vascular internal coagulation;
• pregnant or lactating women;

Sponsors & Collaborators

• Hebei Yanda Ludaopei Hospital: lead
• China Immunotech (Beijing) Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Hebei Yanda Ludaopei Hospital

Sanhe, Hebei, 065200, China

Location

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: May 15, 2019
• First Posted: May 16, 2019
• Study Start: July 1, 2019
• Primary Completion: July 1, 2021
• Study Completion: December 31, 2021
• Last Updated: February 1, 2022

Record last verified: 2021-08

Locations

CN (1)