CD19-CAR-T Cells in Patients With R/R B-ALL

Phase I Study of the Safety and Efficacy of CD19-CAR-T Cells in Patients With Relapsed or Refractory Acute B-cell Lymphoblastic Leukemia (R/R B-ALL)

This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of autologous or donor-derived allogeneic T cells expressing CD19 chimeric antigen receptors (referred to as "CD19-CAR-T cells") in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).

Study Overview

• Status: Unknown
• Conditions: B-cell Acute Lymphoblastic Leukemia
• Intervention / Treatment: Biological: CD19-CAR-T Cells

Detailed Description

Primary objective:

To investigate the safety and efficacy of autologous or HLA-haploidentical Allo-CD19-CAR-T cells in the treatment of patients with relapsed or refractory acute B-cell lymphoblastic leukemia.

Secondary objective:

To Assess the patient's quality of life after receiving the treatment.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhongwei Xu, MD, Phd; Phone Number: +86 010-69739722; Email: willyxu001@bioceltech.com

Study Locations

• China
  • Hebei
    • Langfang, Hebei, China, 065000
      • Recruiting
      • Hebei yanda Ludaopei Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 68 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Obtain Informed Consent Form (ICF) voluntarily signed by the patient;
2. Age 3-70 years old;
3. Primary resistant or relapsed B-cell line acute lymphoblastic leukemia;
4. B cells are positive for CD19 expression;
5. Peripheral blood tumor cell load <50%; 6. KPS score >50 points;

7. Normal liver and kidney function; 8. Normal heart function; 9. Good follow-up compliance; 10. Women of childbearing age (15-49 years old) must have a pregnancy test within 7 days before treatment and have a negative result; Men and women with fertility should agree to use effective contraception to ensure that during the study period and following 3 months after treatment the women will not get pregnant.

Exclusion Criteria:

1. Patients with non-B cell acute leukemia;
2. Organ failure: Heart: Grade III and IV Liver: Class C with Child-Turcotte liver function classification Kidney: Renal failure and uremia Lung: severe respiratory failure Brain: Disabilities
3. Active infection;
4. Human immunodeficiency virus (HIV) positive;
5. Acute and chronic graft-versus-host disease (GVHD)> Level 1；
6. Pregnant or lactating women;
7. Patients do not agree to use effective contraception during the treatment period and following 3 months;
8. Patients who participated in other clinical studies at the same time;
9. The researcher believes that there are other factors that are not suitable for inclusion in or influence the subject's participation in or completion of the study;
10. Long-term use greater doses of hormones than physiological doses.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CD19-CAR-T Cells; Subjects will receive CD19-CAR-T Cells on Day 0 : 100% of total dose.	Biological: CD19-CAR-T Cells; T cells purified from the PBMC of subjects or subjects' relatives which depends on their conditions, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Objective Response Rate, ORR	The percentage of participants who achieved complete remission (CR) over all participants (CRR). The percentage of participants who achieved partial remission (PR) over all participants (PRR).	Up to Day90 after the CD19-CAR-T cell infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of CAR-T cells remaining in vivo	Measure and analyze monthly	2 years after cell infusion.
The lifetime of CAR-T cells remaining in vivo	Measure and analyze monthly	2 years after cell infusion.

Collaborators and Investigators

• Sponsor: Bioceltech Therapeutics, Ltd.
• Investigators: Principal Investigator: Peihua Lu, MD, PhD, Hebei yanda Ludaopei Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): July 20, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: June 11, 2018
• First Submitted That Met QC Criteria: June 20, 2018
• First Posted (Actual): June 29, 2018

Study Record Updates

• Last Update Posted (Actual): June 29, 2018
• Last Update Submitted That Met QC Criteria: June 20, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
• Other Study ID Numbers: BT-ALL-001-v2; ChiCTR1800016541 (Registry Identifier: Chinese Clinical Trial Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No