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Recruiting NCT04603872

CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Hematological Malignancies

Early Phase I Interventional Multiple Myeloma in Relapse Multiple Myeloma, Refractory Acute Lymphoblastic Leukemia, in Relapse Acute Lymphocytic Leukaemia Refractory

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CD19/BCMA Targeted CAR T-cells and dasatinib, CD19/BCMA Targeted CAR T-cells.
Who it may be relevant to
Registry conditions: Multiple Myeloma in Relapse, Multiple Myeloma, Refractory, Acute Lymphoblastic Leukemia, in Relapse, Acute Lymphocytic Leukaemia Refractory. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Clinical Trial for the Safety and Efficacy of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma

Overview

A Study of CD19/BCMA-targeted CAR-T Cells Combined With Dasatinib for Patients With Relapsed and/or Refractory B-cell Acute Lymphoblastic Leukemia, B-cell Non-Hodgkin's Lymphoma and Multiple Myeloma.

Detailed description

This is a double-arm, single-center study. This study is indicated for relapsed and/or refractory B-cell acute lymphoblastic leukemia, B-cell non-Hodgkin's lymphoma and multiple myeloma, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 120 patients will be enrolled for this trial. Primary objective is to explore the safety.

Interventions

  • Drug CD19/BCMA Targeted CAR T-cells and dasatinib
    Each subject receive CS1 Targeted CAR T-cells by intravenous infusion, and the dasatinib was combined according to the presumed regimens.
  • Drug CD19/BCMA Targeted CAR T-cells
    Each subject receive CS1 Targeted CAR T-cells by intravenous infusion.

Primary outcome measures

  • Dose-limiting toxicity (DLT) [Time frame: Baseline up to 28 days after CAR T-cells infusion]
  • Incidence of treatment-emergent adverse events (TEAEs) [Time frame: Up to 2 years after CAR T-cells infusion]
Secondary outcome measures (11)
  • B-cell acute lymphocytic leukemia(B-ALL), Overall response rate (ORR) [Time frame: At Month 1, 3, 6, 12, 18 and 24]
  • B-ALL, Overall survival (OS) [Time frame: Up to 2 years after CAR-T cells infusion]
  • B-ALL, Event-free survival (EFS) [Time frame: Up to 2 years after CAR-T cells infusion]
  • B cell non-hodgkin's lymphoma (B-NHL), Overall response rate (ORR) [Time frame: At Week 4, 12, and Month 6, 12, 18, 24]
  • B-NHL, disease control rate (DCR) [Time frame: At Week 12 and Month 6, 12, 18, 24]
  • Multiple myeloma (MM), Overall response rate (ORR) [Time frame: At Day 28]
  • MM, Overall survival (OS) [Time frame: At Month 6, 12, 24]
  • Quality of life [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]
  • Activities of Daily Living (ADL) score [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]
  • Instrumental Activities of Daily Living (IADL) score [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]
  • Hospital Anxiety and Depression Scale (HADS) score [Time frame: At Baseline, Month 1, 3, 6, 9 and 12]

Eligibility criteria

Inclusion criteria

  • Histologically confirmed diagnosis of CD19+ ALL, CD19+ NHL, or BCMA+ MM per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2020.v2);
  • Relapsed or refractory B cell hematological malignancies (meeting one of the following conditions):
  • CR not achieved after standardized chemotherapy;
  • CR achieved following the first induction, but CR duration is less than 12 months;
  • Ineffectively after first or multiple remedial treatments;
  • 2 or more relapses;
  • Relapse after hematopoietic stem cell transplantation;
  • Extramedullary leisions which were ineffective to radiotherapy or chemotherapy;
  • Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
  • Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
  • No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
  • Estimated survival time ≥ 12 weeks;
  • ECOG performance status 0 to 2;
  • Women of childbearing age had negative pregnancy test during screening period and before administration, and agreed to take effective contraceptive measures at least one year after infusion.
  • Patients volunteer to participate in the study and sign the informed consent.

Exclusion criteria

Subjects with any of the following exclusion criteria were not eligible for this trial:

  • History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular, hemorrhagic diseases;
  • Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
  • Pregnant (or lactating) women;
  • Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
  • Active infection of hepatitis B virus or hepatitis C virus;
  • Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;
  • Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
  • Creatinine >2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin >2.0 mg/dl;
  • Other uncontrolled diseases that were not suitable for this trial;
  • Patients with HIV infection;
  • Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 1 center
  • The First Hospital of Zhejiang Medical Colleage Zhejiang University — Hangzhou

Identifiers

NCT: NCT04603872 · DASA001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗