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Autologous Bedside CD19 CAR T-cell Therapy for B-ALL

ConditionB-Cell Acute Lymphoblastic Leukemia, Adult
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorThe General Hospital of Western Theater Command

About this trial

The purpose of this clinical trial is to learn if autologous bedside CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat B-cell acute lymphoblastic leukemia (B-ALL) in adults. It will also learn about the safety and efficacy of the autologous bedside CD19 CAR-T cell product.

The main questions it aims to answer are:

1. What adverse events occur and the incidence rate of dose-limiting toxicities (DLTs) within 28 days and CAR-T-related adverse events (AEs) after the autologous CD19 CAR-T cell infusion for B-ALL? 2. Which dose level is the optimal biological dose (OBD)? 3. What is the rate of minimal residual disease (MRD) negativity, complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), duration of response (DOR), and overall survival (OS)?

Participants will:

1. Receive autologous bedside CD19 CAR T-cell therapy on Day 0. 2. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. 3. Visit the clinic at Day 7, Day 14, Day 28, then monthly for up to 12 months after CAR-T cells infusion, with continued long-term follow-up for safety and persistence.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 to 70 years inclusive at the time of signing informed consent.

Documented diagnosis of B-cell acute lymphoblastic leukemia (B-ALL) according to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology for Acute Lymphoblastic Leukemia (2018, Version 1) or World Health Organization (WHO) classification criteria.

CD19 expression confirmed by flow cytometry, immunohistochemistry, or pathology on bone marrow, peripheral blood, or tissue specimens. For patients for whom current sampling is not clinically feasible, results from testing performed within 60 days prior to informed consent may be acceptable, as determined by the investigator.

Life expectancy ≥12 weeks in the opinion of the investigator.

Disqualifiers

Active central nervous system (CNS) involvement by B-ALL, defined as CNS-2 or CNS-3 status according to standard criteria.

History of another malignancy within 2 years prior to screening, except for adequately treated basal cell or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.

Patients who previously received CAR-T cell therapy and experienced Grade ≥4 cytokine release syndrome (CRS) or neurotoxicity are specifically excluded.

Treatment with any investigational or approved anti-B-ALL therapeutic agent within 5 half-lives prior to enrollment (excluding supportive care medications).

Trial design

Design model

Single group

Treatments tested in this trial

  • CD19 CAR T cells

    Drug

    intravenous injection of CD19 CAR-T cells

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: CAR T-cell treatmentExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

the incidence rate of CAR-T-related adverse events

Incidence of adverse events(AEs) after infusion, The number, frequency, severity, and laboratory findings of all treatment-related adverse events/serious adverse events are included. Description, time, classification, and outcome of AE events resulted from the investigational medical product, delivery method, or emergency measures will be recorded in the case report form.

Time frame
Up to 28 days after injection
2

The incidence rate of Dose limited toxicity (DLTs)

Dose limited toxicity(DLT) was defined as the occurrence of any of the following adverse events within 28 days of the infusion of CAR-T cells after optimal supportive treatment, which were discussed with the investigator and determined to be associated or likely to be associated with the infusion. Any DTLs within 28 days after CAR-T infusion will be recorded in time, including severity, occurrence time, duration, treatment methods and prognosis.

Time frame
Up to 28 days after infusion

Secondary outcomes

1

the rate of minimal residual disease (MRD) negativity

Time frame
up to 1 year after CAR-T cells infusion
2

overall response rate (ORR)

ORR includes complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), or complete Remission with Partial Hematologic Recovery (CRh).

Time frame
up to 1 year after CAR-T cells infusiion
3

Duration of Response (DOR)

Time frame
up to 1 year after CAR-T cells infusion
4

overall survival (OS)

Time frame
up to 1 year after CAR-T infusion

Other outcomes

1

Area Under the Plasma Concentration Versus Time Curve (AUC) 0-90 days of CAR-T cells

Area under the curve of CAR-T cells in peripheral blood over 90 days

Time frame
up to 90 days after CAR-T cells infusion

Sponsors and contacts

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

The General Hospital of Western Theater Command

Lead sponsor

Chengdu Ucello Biotechnology Co., Ltd.

Collaborator

Source ClinicalTrials.gov

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