CD19/CD22-Dual-STAR-T for Patients With B Cell Acute Leukemia(B-ALL)

NCT04508842 | Terminated Phase 1 DMC

• 1 other identifier: HXYT-011
• Study Type: interventional
• Target: 2
• 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/CD22-Dual-STAR-T cells in patients with refractory and relapsed B cell acute leukemia .

Conditions

Refractory and Relapsed B Cell Acute Leukemia

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with adverse events.

  Percentage of participants with adverse events.

  12 months

Secondary Outcomes (2)

• Objective Remission Rate(ORR)

  12 months

• Proliferation ratio of Dual-STAR-T cells

  12 months

Study Arms (1)

CD19/CD22-Dual-STAR-T

EXPERIMENTAL

CD19/CD22-Dual-STAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of Dual-STAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 500mg/m2 for 3 days and take a rest for 2 days before infusion. Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.

Biological: CD19/CD22-Dual-STAR-T

Interventions

CD19/CD22-Dual-STAR-T BIOLOGICAL

Patients with B cell acute leukemia will be enrolled, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD22-Dual-STAR-T cells.Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.

CD19/CD22-Dual-STAR-T

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:

• Ages 1 to 70 years.
• Prelapsed and refractorys B-ALL at least with one of the following conditions:
• Could not achieve CR after 2course of chemotherapy.
• Could not achieve CR or relapse after first-line or multi-line salvage chemotherapy, or MRD≥0.1%.
• Relapse within 12 months after first remission or MRD≥0.1%.
• Relapse after achieved CR in allogeneic hematopoietic stem cell transplantation (HSCT), or MRD≥0.1%.
• For Ph + patients: Failure to tolerate TKI or TKI treatment failure could be enrolled.
• CD19 and/or CD22 positive within 3 months.
• ECOG 0-2.
• Estimated life expectancy ≥ 3 months.
• Women of childbearing age 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 12 months after discontinuation of treatment during the study period not pregnant inside.
• Patients who voluntarily sign informed consent and are willing to comply with treatment plans, visit arrangements, laboratory tests and other research procedures.

You may not qualify if:

• Active infections that are difficult to control
• HBV-DNA HCV-RNA and HIV ,either of which is positive
• Central nervous system leukemias that is symptomatic or uncontrolled by systemic chemotherapy and intrathecal chemotherapy
• Patients are receiving anti-GVHD treatment within 4 weeks of before screening.
• Performed major surgery within 4 weeks before screening.
• Patients have received chemotherapy within 7 days of screening.
• Experimental drugs were used within 4 weeks before screening.
• Received allogeneic cell therapy within 6 weeks prior to cell infusion.
• Patients have history of epilepsy or central nervous system diseases.
• Severe thyroid dysfunction
• Patients with active autoimmune disease.
• Pregnant or lactating women.
• The patient does not agree to use effective contraception during treatment and for the following 12 months;
• The researchers found that it was unsuitable for the recipients to be enrolled.

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 Officials

• Xian Zhang, PhD

  Hebei Yanda Ludaopei Hospital

  STUDY DIRECTOR

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: August 9, 2020
• First Posted: August 11, 2020
• Study Start: October 10, 2020
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: September 28, 2022

Record last verified: 2022-05

Locations

CN (1)