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A Study of CD20/CD22 Targeted CAR T-cell Therapy for Relapsed or Refractory Lymphoid Malignancies

ConditionsRelapsed and RefractoryLymphoid Hematological Malignancies
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age3-70
SponsorHe Huang

About this trial

A Study of CD20/CD22 Targeted CAR T-cell Therapy for Relapsed or Refractory Lymphoid Malignancies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female aged ≥ 3 and <70 years old;

Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);

CR not achieved after standardized chemotherapy;

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

Disqualifiers

patients with extramedullary lesions, except those with CNSL (CNS-1) under effective control (for ALL patients only);

Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/lymphoma per WHO Classification Criteria (for ALL patients only);

Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome (for ALL patients only);

Patients with intracranial extralateral lesions (cerebrospinal fluid tumor cells and/or intracranial lymphoma invasion shown by MRI) (for NHL patients only) ;

Trial design

Design model

Single group

Treatments tested in this trial

  • CD20/CD22 dual Targeted CAR T-cells

    Drug

    Each subject receive CD20/CD22 dual Targeted CAR T-cells by intravenous infusion

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Administration of CD20/CD22 dual 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 CD20/CD22 targeted 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 CD20/CD22 targeted CAR T-cells infusion

Secondary outcomes

1

B-cell acute lymphocytic leukemia (B-ALL), MRD negative overall response rate (MRD- ORR)

Assessment of MRD negative overall response rate (MRD- ORR) at 3 months after CD20/CD22 targeted CAR T-cells infusion

Time frame
3 months
2

B-ALL, Event-free survival (EFS)

From the first infusion of CD20/CD22 targeted CAR T-cells to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit

Time frame
Month 6, 12, 18 and 24
3

B-ALL, Overall response rate (ORR)

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

Time frame
Month 6, 12, 18 and 24
4

B-ALL, Overall survival (OS)

From the first infusion of CD20/CD22 targeted CAR T-cells to death or the last visit

Time frame
Month 6, 12, 18 and 24

Other outcomes

Sponsors and contacts

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

He Huang

Lead sponsor

Zhejiang University

Sponsor institution

Yake Biotechnology Ltd.

Collaborator

Source ClinicalTrials.gov
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