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

ConditionsMultiple Myeloma in RelapseMultiple Myeloma, RefractoryAcute Lymphoblastic Leukemia, in RelapseAcute Lymphocytic Leukaemia RefractoryNon-Hodgkin's Lymphoma, RelapsedNon-Hodgkin's Lymphoma Refractory
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorZhejiang University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed diagnosis of CD19+ ALL, CD19+ NHL, or BCMA+ MM per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines (2020.v2);

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;

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • CD19/BCMA Targeted CAR T-cells and dasatinib

    Drug

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

  • CD19/BCMA Targeted CAR T-cells

    Drug

    Each subject receive CS1 Targeted CAR T-cells by intravenous infusion.

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Administration of CD19/BCMA Targeted CAR T-cells and dasatinibExperimental treatment 1 intervention
Group B: Administration of CD19/BCMA Targeted CAR T-cellsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Adverse events assessed according to NCI-CTCAE v5.0 criteria

Time frame
Baseline up to 28 days after CAR T-cells infusion
2

Incidence of treatment-emergent adverse events (TEAEs)

Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

Time frame
Up to 2 years after CAR T-cells infusion

Secondary outcomes

1

B-cell acute lymphocytic leukemia(B-ALL), Overall response rate (ORR)

Assessment of ORR (ORR = CR + CRi) at Month 6, 12, 18 and 24

Time frame
At Month 1, 3, 6, 12, 18 and 24
2

B-ALL, Overall survival (OS)

From the first infusion of CAR-T cells to death or the last visit

Time frame
Up to 2 years after CAR-T cells infusion
3

B-ALL, Event-free survival (EFS)

From the first infusion of CAR-T cells to the occurrence of any event, including death, relapse orgene relapse, disease progression (any one occurs first), and the last visit

Time frame
Up to 2 years after CAR-T cells infusion
4

B cell non-hodgkin's lymphoma (B-NHL), Overall response rate (ORR)

Assessment of ORR (ORR = CR + PR) per Lugano 2014 criteria

Time frame
At Week 4, 12, and Month 6, 12, 18, 24

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhejiang University

Lead sponsor

Yake Biotechnology Ltd.

Collaborator

Source ClinicalTrials.gov
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