Health TrialsbyHealthPanel

A Study of CAR T-Cells in Relapsed/Refractory Hematologic Malignancy

ConditionsRelapsed/refractory LymphomaRelapsed/Refractory Leukemia
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorAffiliated Hospital of Nantong University

About this trial

This study is a single-center, open-label clinical trial of single-dose of CAR T-cells in subjects with relapsed/refractory hematologic malignancy.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Voluntarily participate in the clinical study. The individual or the legal guardian fully understands the study, sign the informed consent form (ICF), and is willing and able to follow and complete all trial procedures.

Age ≥ 18 years and < 70 years.

Disease progression (PD) as assessed after first-line treatment.

Best response of SD after at least 4 cycles of first-line treatment (e.g., 4 cycles of RCHOP), with SD duration not exceeding 6 months after the last dose.

Disqualifiers

CNS-3 disease is defined as detectable tumor cells in the cerebrospinal fluid (CSF) sample with ≥ 5 WBCs/mm^3, with or without neurological changes.

CNS-2 disease is defined as detectable tumor cells in the CSF sample with < 5 WBCs/mm^3 and with neurological changes.

Brain MRI evidence shows central nervous system lymphoma. Active primary central nervous system DLBL, unless CNS involvement has been effectively treated (i.e., participants are asymptomatic) and there has been a local treatment interval of >4 weeks prior to enrollment.

Presence of active central nervous system diseases, such as epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, or any autoimmune diseases with CNS involvement.

Trial design

Design model

Single group

Treatments tested in this trial

  • anti-CD19-CAR T-cells, or anti-CD30-CAR T-cells, or anti-CD20/CD30-CAR T-cells

    Biological/Vaccine

    Each subject will be infused with single dose. A classic "3+3" dose escalation will be employed. anti-CD19-CAR T-cells Dose level 1：1x10\^5 CAR T cells/kg, Dose level 2：3x10\^5 CAR T cells/kg, Dose level 3：1x10\^6 CAR T cells/kg anti-CD30-CAR T-cells Dose level 1：3x10\^6 CAR T cells/kg, Dose level 2：6x10\^6 CAR T cells/kg, Dose level 3：1x10\^7 CAR T cells/kg anti-CD20/CD30-CAR T-cells Dose level 1：1x10\^6 CAR T cells/kg, Dose level 2：3x10\^6 CAR T cells/kg, Dose level 3：1x10\^7 CAR T cells/kg

  • Fludarabine

    Drug

    Fludarabine will be given at a dose of 25 mg/m\^2/day intravenously (IV) for 3 days prior to the infusion of CAR T-cells.

  • Cyclophosphamide

    Drug

    Cyclophosphamide will be given at a dose of 250 mg/m\^2/day intravenously (IV) for 3 days prior to the infusion of CAR T-cells.

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: Cyclophosphamide + Fludarabine + CAR T-CellsExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Evaluate safety and tolerability of CAR T-cells

Proportion of subjects experiencing dose-limiting toxicities (DLT)

Time frame
28 days after infusion of CAR T-cells
2

Evaluate the feasibility of administration of CAR T-cells

The proportion of subjects for whom the desired dose of CAR T-cells can be successfully manufactured

Time frame
12 months

Secondary outcomes

1

Adverse events

Will be assessed using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0. AEs will be summarized in terms of type (organ affected or laboratory determination), severity, time of onset, duration, probable association with the study treatment and reversibility or outcome.

Time frame
12 months
2

Incidence of cytokine release syndrome (CRS) and neurotoxicity

Will be assessed using ASTCT Criteria.

Time frame
12 months
3

Evaluate cellular kinetics and persistence of CAR T-cells

Test Copy number of CAR in peripheral blood

Time frame
28 days after CAR T infusion, after which the evaluation is at the discretion of investigator
4

Preliminary anti-tumor effect

Efficacy evaluation will be based on the National Comprehensive Cancer Network guidelines version 1. 2022 (ALL), or Lugano criteria (Lymphoma)

Time frame
12 months

Other outcomes

Sponsors and contacts

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

Affiliated Hospital of Nantong University

Lead sponsor

Shanghai First Song Biotechnology Co., LTD

Collaborator

Source ClinicalTrials.gov
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