C-CAR011 Treatment in Subjects With ALL After HSCT

Not Applicable

• Conditions: Acute Lymphoblastic Leukemia(ALL)
• Interventions: Biological: C-CAR011

• Registration Number: NCT03327285
• Lead Sponsor: Peking University People's Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2017-08-17
• Study First Submitted QC: 2017-10-29
• Study First Posted: 2017-10-31
• Study Start: 2018-03-01
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-30
• Last Update Posted: 2020-10-01
• Primary Completion: 2021-02-28
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
C-CAR011	C-CAR011	The amount of cells received：1.0-5.0×10\^6 CAR+T cells/kg

Primary Outcome Measures

Name	Time	Method
TEAEs	2 months	TEAEs evaluated after C-CAR011 infusion
GVHD	2 months	GVHD evaluated after C-CAR011 infusion

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking University Institute of Hematology; 🇨🇳 Beijing, Beijing, China