QH103 Cell Injection for the Treatment of Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

NCT ID: NCT06056752

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-27
• Study Completion Date: 2026-07-03

Brief Summary

This is a single-arm, single-center, interventional, dose-escalation clinical study designed to evaluate the safety and tolerability of QH103 Cell Injection in the treatment of patients with relapsed/refractory B-cell acute lymphoblastic leukemia.

Detailed Description

To evaluate the safety and tolerability of QH103 Cell Injection in the treatment of relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia, and to evaluate dose-limiting toxicity and maximum tolerated dose.

Conditions

B-cell Acute Lymphoblastic Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients with relapsed/refractory CD19-positive B-cell acute lymphoblastic leukemia

A conditional chemotherapy regimen of fludarabine and cyclophosphamide will be administered, followed by investigational therapy, QH103 Cells

Group Type: EXPERIMENTAL

QH103 Cell Injection

Intervention Type: BIOLOGICAL

dose escalation (3+3) : dose 1 (3×10\^8CAR+cells) ,dose 2 (1 × 10\^9 CAR+cells）,dose 3 (3 × 10\^9CAR+cells)

Fludarabine

Intervention Type: DRUG

Intravenous fludarabine on days-5\~-2,the infusion dose is adjusted according to the subject's condition

Cyclophosphamide

Intervention Type: DRUG

Intravenous cyclophosphamide on days -5\~-3, the infusion dose is adjusted according to the subject's condition

Interventions

QH103 Cell Injection

dose escalation (3+3) : dose 1 (3×10\^8CAR+cells) ,dose 2 (1 × 10\^9 CAR+cells）,dose 3 (3 × 10\^9CAR+cells)

Intervention Type: BIOLOGICAL

Fludarabine

Intravenous fludarabine on days-5\~-2,the infusion dose is adjusted according to the subject's condition

Intervention Type: DRUG

Cyclophosphamide

Intravenous cyclophosphamide on days -5\~-3, the infusion dose is adjusted according to the subject's condition

Intervention Type: DRUG

Other Intervention Names

Fludarabine Phosphate for Injection; Cyclophosphamide for Injection

Eligibility Criteria

Inclusion Criteria

1. Age ≥14 years, gender is not limited;

2. Patients with clinically diagnosed relapsed/refractory B-ALL (except those presenting with extramedullary disease only), including any of the following:

1. Failure to obtain CR after 2 cycles of standard chemotherapy;

2. First induction of CR, but duration of CR is ≤12 months;

3. Relapsed/refractory B-ALL that has failed to respond to the first or multiple salvage treatments;

4. Relapse after hematopoietic stem cell transplantation, including hematological relapse and positive micro residual disease (MRD).

3. Cytological or histological confirmation of tumor cell immunophenotyping as CD19 positive;

4. Bone marrow with a ratio of ≥5% primitive/naïve lymphocytes (morphology);

5. Expected survival time of more than 3 months;

6. Eastern Cooperative Oncology Group (ECOG) score of 0-2;

7. Vital organ function meets the following requirements: left ventricular ejection fraction ≥50% on echocardiography; serum creatinine≤1.5 × upper limit of normal range (ULN); glutamine aminotransferase, aspartate aminotransferase ≤3 times ULN, total bilirubin ≤1.5 times ULN;

8. Pregnancy tests for women of childbearing age should be negative, and both men and women should agree to use effective contraception during treatment and for the following 1 year.

Exclusion Criteria

10. No significant hereditary disease;

11. Be able to understand the requirements and matters of the trial and be willing to participate in the clinical study as required;

12. Sign the trial informed consent form.

1. with uncontrolled active central nervous system leukemia (CNSL) or a history of epilepsy, cerebrovascular disease

2. Pregnant or lactating women, or those who do not consent to the use of the drug during and within 1 year after treatment;

3. Other malignant tumors not in remission;

4. with primary immunodeficiency or autoimmune diseases requiring immunosuppressive therapy;

5. Patients who have received immune cell therapy within 6 months prior to enrollment and donor lymphocyte infusion within 6 weeks prior to enrollment.

6. Patients with confirmed positive serum anti-FMC63 and DSA reactions;

7. Patients who have participated in other clinical trials within 4 weeks prior to enrollment;

8. Uncontrolled infectious or other serious diseases, including but not limited to infections (Human Immunodeficiency Virus, acute or chronic active hepatitis B or hepatitis C), congestive heart failure, unstable angina pectoris cardiac arrhythmias, or conditions that the attending physician considers to be an unpredictable risk;

9. Uncontrollable plasma fluid, such as large pleural effusions or ascites;

10. History of stroke or intracranial hemorrhage within 3 months prior to enrollment;

11. Major surgery or trauma within 28 days prior to enrollment, or major side effects from which you have not recovered;

12. History of allergy to any of the ingredients in the cellular product;

13. Inability to understand or unwillingness to sign the informed consent form;

14. Other reasons deemed by the investigator to be unsuitable for the clinical trial.

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Anhui Provincial Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Xiaoyu Zhu

Director of Hematology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoyu Zhu, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Director of Hematology Department, Anhui Provincial Hospital

Locations

Anhui Provincial Hospital

Hefei, Anhui, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xiaoyu Zhu, Ph.D

Role: CONTACT

xiaoyuz@ustc.edu.cn

+86 15255456091

Guangyu Sun

Role: CONTACT

sunguangyu_vip@foxmail.com

+86 13956970687

Facility Contacts

Zhu Xiaoyu, Ph.D

Role: primary

xiaoyuz@ustc.edu.cn

+86 15255456091

Sun Guangyu

Role: backup

sunguangyu_vip@foxmail.com

+86 13956970687

Other Identifiers

QH10302-B-01(0)

Identifier Type: -

Identifier Source: org_study_id