CAR-T-19 Cells for Patients With CD19+ Relapse/Refractory B-ALL

NCT05270772 | Unknown Phase 1 DMC

• 1 other identifier: CT19-ALL-02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-arm, open-label phase I study to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19 cells for patients with CD19+ relapse/refractory B-ALL under the age of 25.

Conditions

CD19+ Relapse/Refractory B-ALL

Keywords

B-ALL; CAR-T

Outcome Measures

Primary Outcomes (3)

• Dose limiting toxicity (DLT)

  DLT within 28 days (±3 days) after CAR-T-19 infusion.

  up to 2 years

• Maximum tolerated dose (MTD)

  The maximum dose of DLT occurred in ≤1/6 of the subjects within 28 days (±3 days) after CAR-T-19 infusion.

  up to 2 years

• Adverse events

  Percentage of subjects with adverse events.

  up to 2 years

Secondary Outcomes (5)

• Overall recovery rate (ORR)

  up to 2 years

• MRD-Negative Rate

  up to 2 years

• Duration of Response (DOR)

  up to 2 years

• Progression-free Survival (PFS)

  up to 2 years

• Overall survival (OS)

  up to 2 years

Study Arms (1)

CAR-T-19 Cells

EXPERIMENTAL

The patients with CD19+ relapse or refractory B-ALL will receive a single infusion of autologous CAR-T-19 cells, with the escalated dose ranging from 0.5×10\^6/kg to 5.0×10\^6/kg CAR+ cells.

Biological: CAR-T-19 Cells

Interventions

CAR-T-19 Cells BIOLOGICAL

T cells were isolated from the PBMC of patients, transduced with lentivirus, expanded in vitro, and infused into patients. The escalated doses include 0.5×10\^6/kg,1.5×10\^6/kg, 5.0×10\^6/kg CAR+ cells.

CAR-T-19 Cells

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with relapse/refractory B-ALL.
• Tumor cells from bone marrow or peripheral blood are measured CD19+ with 3 months before enrollment.
• Karnofsky Score ≥ 70 or Lansky Score ≥ 50.
• Patients who have a life expectancy of at least 12 weeks.
• Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures.

You may not qualify if:

• Patients with extramedullary relapse (EMR).
• Patients with genetic diseases, Burkitt lymphoma and leukemia or other malignancies.
• Patients positive for any of the following: HbsAg, HBV-DNA, HCV-Ab, HCV-RNA, HIV-Ab, TP-Ab, EBV-DNA or CMV-DNA.
• Patients with other uncontrolled infection.
• Patients who received anti-CD19 / anti-CD3 therapy, or any other anti-CD19 therapy.
• Patients with active Grade II-IV GVHD within 3 months prior to screening.
• Tumor cells are detected in cerebrospinal fluid.
• Patients who received HSCT within 3 months prior to screening.
• Anticipated other clinical trials within 4 weeks before this trial
• Pregnant or lactating women.
• Any condition that would, in the investigator's judgment, make it unsuitable for the donors to be enrolled.

Sponsors & Collaborators

• Chinese PLA General Hospital: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

Study Officials

• Daihong Liu

  Chinese PLA General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daihong Liu

CONTACT

+8613681171597; daihongrm@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 26, 2022
• First Posted: March 8, 2022
• Study Start: February 25, 2021
• Primary Completion: July 15, 2022
• Study Completion: September 16, 2024
• Last Updated: March 8, 2022

Record last verified: 2022-01

Locations

CN (1)