Health TrialsbyHealthPanel

CD19-BAFF CAR-T Cells Therapy for Patients With Relapsed / Refractory B-cell ALL and B-cell NHL

ConditionsAcute Lymphoblastic Leukemia,B-CellNon-hodgkin Lymphoma,B Cell
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorZhejiang University

About this trial

Clinical Trial for the safety and efficacy of CD19-BAFF CAR-T cells therapy for refractory/relapsed B-cell acute lymphoblastic leukemia and B-cell non-Hodgkin lymphoma.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1. Gender unlimited，18< Age;

2. Patients diagnosed with B-cell acute lymphoblastic leukemia through histological or immunophenotyping tests; The clear diagnosis of B-cell non Hodgkin's lymphoma by cellular or histopathological examination mainly includes diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma

CR not achieved after standardized chemotherapy;

CR achieved following the first induction, but CR duration is less than 12 months;

Disqualifiers

1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;

2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;

3. Pregnant/lactating women, or male or female patients with fertility who are unwilling to take effective contraceptive measures during the study period or at least 6 months after the last cell infusion

4. Patients with HIV infection;

Trial design

Design model

Single group

Treatments tested in this trial

  • CD19-BAFF Targeted CAR T-cells

    Biological/Vaccine

    Each subject receive CD19-BAFF Targeted CAR T-cells by intravenous infusion

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Administration of CD19-BAFF 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
Up to 28 years after Treatment
2

Incidence of treatment-emergent adverse events (TEAEs)

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

Time frame
Up to 2 years after Treatment

Secondary outcomes

1

Overall response rate ,ORR

The proportion of patients with CR (complete response) /CRi (complete response with incomplete blood cell recovery) and PR (partial response).

Time frame
Up to 12 weeks after CAR-T infusion
2

Duration of remission ,DOR

The time from CR/CRi and PR to disease relapsed or death due to disease progression after CAR-T infusion

Time frame
Up to 1 years after CAR-T infusion
3

Event-free survival, EFS

The time from first achieving CR/CRi to relapse or death

Time frame
Up to 1 years after CAR-T infusion
4

Overall survival, OS

The time from CAR-T infusion to death due to any cause

Time frame
Up to 1 years after CAR-T infusion

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
Apply now