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

• Sponsor: Chinese PLA General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05270772
• Collaborator: (none)
• Enrollment: 9
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 42.7
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
CD19+ Relapse/Refractory B-ALL	Biological: CAR-T-19 Cells	Phase 1

Detailed Description

B-cell acute lymphoblastic leukemia (B-ALL) accounting for 85% of all ALL cases, is a common hematological malignancy in children and adults. CD19 is a widely expressed antigen in both normal B cells and B cells-derived leukemia and lymphomas. This is a single-arm, open-label phase I study of CAR-T-19 (anti CD19 scFv chimeric antigen receptor T) cells for patients with CD19-positive relapse/refractory B-ALL under the age of 25.

Primary endpoint is to determine the safety, tolerability, and recommended dose (RD) of CAR-T-19. Secondary endpoints measure ORR, OS and others.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 9 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Single-arm, Open-label Phase I Study of CAR-T-19 (Anti CD19 scFv Chimeric Antigen Receptor T) Cells for Patients With CD19-positive Recurrent or Refractory B-cell Acute Lymphoblastic Leukemia Under The Age of 25
• Actual Study Start Date: Feb 25, 2021
• Anticipated Primary Completion Date: Jul 15, 2022
• Anticipated Study Completion Date: Sep 16, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: CAR-T-19 Cells 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; 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.

Outcome Measures

Primary Outcome Measures

1. Dose limiting toxicity (DLT) [up to 2 years]

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

2. Maximum tolerated dose (MTD) [up to 2 years]

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

3. Adverse events [up to 2 years]

   Percentage of subjects with adverse events.

Secondary Outcome Measures

1. Overall recovery rate (ORR) [up to 2 years]

   Percentage of subjects who achieved complete response (CR) and incomplete hematologic recovery (CRi) for the first time at Day 28 and Day 90 after CAR-T-19 infusion.

2. MRD-Negative Rate [up to 2 years]

   Percentage of subjects with MRD-negative CR and incomplete blood and MRD-negative CRi for the first time at Day 28 and Day 90 after CAR-T-19 infusion.

3. Duration of Response (DOR) [up to 2 years]

   The time from achieving CR and CRi for the first time to recurrence or death from any cause

4. Progression-free Survival (PFS) [up to 2 years]

   The time from CAR-T-19 infusion to recurrence, progression or death from any cause, whichever occurs first.

5. Overall survival (OS) [up to 2 years]

   The time from CAR-T-19 infusion to death from any cause.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 25 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chinese PLA General Hospital	Beijing	Beijing	China	100853

Sponsors and Collaborators

• Chinese PLA General Hospital

Investigators

• Principal Investigator: Daihong Liu, Chinese PLA General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Daihong Liu, Director, Chinese PLA General Hospital
• ClinicalTrials.gov Identifier: NCT05270772
• Other Study ID Numbers: CT19-ALL-02
• First Posted: Mar 8, 2022
• Last Update Posted: Mar 8, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Daihong Liu, Director, Chinese PLA General Hospital: B-ALL; CAR-T
• Additional relevant MeSH terms: Recurrence

Study Results

No Results Posted as of Mar 8, 2022