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Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies

ConditionsRelapsed/Refractory Hematological MalignanciesLymphomaMyelomaLeukemia
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorThe Affiliated People's Hospital of Ningbo University

About this trial

The primary purpose of this study is to determine the safety and efficacy of novel autologous CAR-T cells in patients with relapsed/refractory hematological malignancies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histological diagnosis of hematological malignancies (such as lymphoma, myeloma, leukemia) refractory to, or relapsing after standard therapy.

Positive expression of specific antigens.

Eastern Cooperative Oncology Group (ECOG) performance status of 0~2.

Serum bilirubin ≤ 35 μmol/L;

Disqualifiers

History of allergy to any of the drugs involved in the protocol.

Left ventricular ejection fraction (LVEF) < 50%;

Class III or IV heart failure as defined by the New York Heart Association (NYHA).

History of another malignancy tumor.

Trial design

Design model

Single group

Treatments tested in this trial

  • Autologous CAR-T cells

    Biological/Vaccine

    D0: CAR-T cells will be infused intravenously.

  • Fludarabine

    Drug

    D-5 to D-3: Fludarabine (30 mg/m\^2/day) will be administered intravenously for 3 days.

  • Cyclophosphamide

    Drug

    D-5 to D-3: Cyclophosphamide (500 mg/m\^2/day) will be administered intravenously for 3 days.

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: Autologous CAR-T cellsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

TEAEs

Incidence and severity of Treatment Emergent Adverse Event.

Time frame
4 weeks
2

TRAEs

Incidence and severity of Treatment Related Adverse Events.

Time frame
4 weeks
3

AESIs

Incidence and severity of AEs of Special Interest.

Time frame
4 weeks

Secondary outcomes

1

Objective Response Rate (ORR) (PR+CR)

The proportion of patients with complete response(CR) or partial response(PR)

Time frame
12 months
2

Progression-Free Survival (PFS)

PFS was defined as the time from CAR-T infusion to the date of disease progression or death from any cause. Participants not meeting the criteria for progression by the analysis data cutoff date were censored at their last evaluable disease assessment date.

Time frame
12 months
3

Overall survival (OS)

OS was defined as the time from CAR-T infusion to the date of death. Participants who did not die by the analysis data cutoff date were censored at their last contact date.

Time frame
12 months

Other outcomes

Sponsors and contacts

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

The Affiliated People's Hospital of Ningbo University

Lead sponsor

UTC Therapeutics Inc.

Collaborator

Source ClinicalTrials.gov
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