C-CAR011 Treatment in Subjects With ALL After HSCT

A Study Evaluating Safety and Efficacy of CBM.CD19-targeted Chimeric Antigen Receptor T Cells (C-CAR011) Treatment in Subjects With Acute Lymphoblastic Leukemia(ALL) After Hematopoietic Stem Cell Transplantation（HSCT）

This is a single-center, prospective clinical study evaluating safety and efficacy of C-CAR011 treatment in subjects with ALL after HSCT

Study Overview

• Status: Unknown
• Conditions: Acute Lymphoblastic Leukemia(ALL)
• Intervention / Treatment: Biological: C-CAR011

Detailed Description

A study evaluating safety and efficacy of CBM.CD19-targeted chimeric antigen receptor T cells (C-CAR011) treatment in subjects with acute lymphoblastic leukemia(ALL) after hematopoietic stem cell transplantation（HSCT）. The amount of cells received：1.0-5.0×10^6CAR+T cells/kg

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University Institute of Hematology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 65 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 15-65 years old, male or female.
• Volunteered to participate in this study and signed informed consent.
• Meet the two populations above.
• Histologically diagnosed as CD19+B-ALL.
• 100% T lymphocytes of donor.
• Treatment without chemotherapy and antibody therapy within 2 weeks prior to C-CAR011 therapy.
• Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion and clinically significant arrhythmias.
• Baseline oxygen saturation ≧ 92% on room air and with normal pulmonary function, no evidence of active lung infection.
• Expected survival ≧ 3 months.
• Eastern cooperative oncology group (ECOG) performance status of 0 or 1.

Exclusion Criteria:

• History of allergy to cellular products.
• Any kind of these laboratory testing: serum total bilirubin≧2.0mg/dl, serum albumin<35g/L, ALT, AST≧3×ULN, serum creatinine≧2.0mg/ dl,platelets<20×109/L.
• The subjects had active aGVHD with II-IV degrees (Glucksberg degrees) or active moderate to severe cGVHD.
• Severe uncontrolled infection (mycotic, bacterial, virus and so on).
• Any central nervous system leukemia(CNS2, CNS3) , with insensitive to intrathecal injection of or radiotherapy of head/spine; but effectively controlled cases will be eligible.
• The subjects were treated CART cells or DLI after HSCT.
• Bone marrow failure syndrome（BMF） after allogeneic hematopoietic stem cell transplantation.
• Any genetically modified T cell therapy.
• History of heavy drinking, drug taking or mental disease.
• Participated in any other clinical trial within one month prior to enrollment.
• Women who are pregnant or lactating or have breeding intent in 6 months.
• The investigators believe that any increase in the risk of the subject or interference with the results of the trial.

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: C-CAR011; The amount of cells received：1.0-5.0×10^6 CAR+T cells/kg	Biological: C-CAR011; CBM.CD19-targeted chimeric antigen receptor T cells(C-CAR011); Other Names: Anti-CD19 chimeric antigen receptor T cells (C-CAR011)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TEAEs	TEAEs evaluated after C-CAR011 infusion	2 months
GVHD	GVHD evaluated after C-CAR011 infusion	2 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrence rate	Recurrence rate	6 and 12 months
OS	Overall survival (OS) after C-CAR011 infusion	12 months
PFS	Progression free survival（PFS）after C-CAR011 infusion	12 months
Remission rate	MRD negative after C-CAR011 infusion	2 weeks to 3 months

Collaborators and Investigators

• Sponsor: Peking University People's Hospital
• Collaborators: Cellular Biomedicine Group Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): February 28, 2021
• Study Completion (Anticipated): April 30, 2021

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: October 29, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): October 1, 2020
• Last Update Submitted That Met QC Criteria: September 30, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Hematopoietic stem cell transplantation; Acute lymphoblastic leukemia; Anti-CD19 chimeric antigen receptor T-cell
• 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: 2017PHB033-01; CBMG-C2017004 (Other Identifier: CBMG)

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