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CD19/70 Bi-specific CAR-T Cell Therapy

ConditionB Cell Malignancies
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age6-75
SponsorShenzhen Geno-Immune Medical Institute

About this trial

The purpose of this study is to assess the feasibility, safety and efficacy of CD19/70 bi-specific CAR-T cell therapy in patients with CD19 and/or CD70 positive B cell malignancies. Another goal of the study is to learn more about the safety and function of the anti-CD19/70 bi-specific CAR-T cells and their persistency in patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age older than 6 months.

malignant B cell surface expression of CD19 or CD70 molecules.

the KPS score over 80 points, and survival time is more than 1 month.

greater than Hgb 80 g/L.

Disqualifiers

accompanied with other active diseases and difficult to assess patient response.

bacterial, fungal, or viral infection, unable to control.

living with HIV.

active HBV or HCV infection.

Trial design

Design model

Single group

Treatments tested in this trial

  • bi-4SCAR CD19/70 T cells

    Biological/Vaccine

    Infusion of bi-4SCAR CD19/70 T cells at 10\^6 cells/kg body weight via IV

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: bi-4SCAR-CD19/70 T Cell Therapy for CD19 and/or CD70 positive B cell malignanciesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety of fourth generation bi-4SCARCD19/70 T cells in patients with B cell malignancies

Safety of fourth generation bi-4SCARCD19/70 T cells in patients with B cell malignancies using CTCAE 4 standard to evaluate the level of adverse events standard to evaluate the level of adverse events

Time frame
12 weeks

Secondary outcomes

1

Anti-tumor activity of fourth generation bi-4SCARCD19/70 T cells in patients with relapsed or refractory B cell malignancies

Scale of CAR copies (for efficacy)

Time frame
1 year
2

Anti-tumor activity of fourth generation bi-4SCARCD19/70 T cells in patients with relapsed or refractory B cell malignancies

Scale of leukemic cell burden (for efficacy)

Time frame
1 year

Other outcomes

Sponsors and contacts

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

Shenzhen Geno-Immune Medical Institute

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: