Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia

NCT04684147 | Recruiting Phase 2

• 1 other identifier: HY001201
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 11

Brief Summary

The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia.

Conditions

Relapsed or Refractory Acute Lymphoblastic Leukemia

Outcome Measures

Primary Outcomes (1)

• Overall Remission Rate (ORR), which includes Complete Remission (CR) and Complete Remission with Incomplete Blood Count Recovery (CRi) as determined by Independent Review Committee (IRC).

  The Investigators' evaluation results of ORR will be subjected to sensitivity analysis.

  At 3 months after infusion

Secondary Outcomes (14)

• Overall Remission Rate (ORR) with minimal residual disease (MRD) negative bone marrow as determined by IRC and Investigators.

  3 months

• Overall Remission Rate (ORR) as determined by IRC and Investigators.

  28 days

• Overall Remission Rate (ORR) with minimal residual disease (MRD) negative bone marrow as determined by IRC and Investigators.

  28 days

• Relapse Free Survival (RFS) as determined by IRC and Investigators.

  2 years

• Event free survival (EFS) as determined by IRC and Investigators.

  2 years

Study Arms (1)

Single dose of CNCT19

EXPERIMENTAL

A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by investigational treatment, CNCT19.

Biological: single dose of CNCT19

Interventions

single dose of CNCT19 BIOLOGICAL

Dose: 0.5 x 10\^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide

Single dose of CNCT19

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent is signed by the subject.
• Age 18 to 65.
• Relapsed or refractory acute lymphoblastic leukemia (ALL). (1) Relapse within 12 months of first remission; (2)a. Without remission after more than 6 weeks of induction chemotherapy or without remission after 2 cycles of induction chemotherapy regimen; c. 2nd or greater Bone Marrow (BM) relapse OR; d. First relapse after chemotherapy, without remission after at least 1 rescue treatment; e. Any BM relapse after autologous or allogeneic stem cell transplantation (SCT).
• Documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood within 3 months of study entry.
• Patients with Philadelphia chromosome positive (Ph+) ALL are eligible if they are intolerant to or have failed 2 generation of tyrosine kinase inhibitor therapy (TKI); no TKI salvage treatments if the patient has a T315I mutation.
• Bone marrow with ≥ 5% lymphoblasts by morphologic assessment at screening.
• Eastern cooperative oncology group (ECOG) performance status of 0 to 1.
• Adequate organ function defined as:
• aspartate aminotransferase (AST) ≤ 3 upper limit of normal (ULN);
• Serum alanine aminotransferase (ALT) ≤ 3 upper limit of normal (ULN);
• Total bilirubin ≤ 2 ULN, except in individuals with Gilbert's syndrome; Note: Patients with Gilbert's syndrome that bilirubin ≤ 3 ULN and direct bilirubin ≤ 1.5 ULN will be eligible;
• A serum creatinine≤ 1.5 ULN or Creatine removal rate ≥ 60mL/min (Cockcroft and Gault）;
• Must have a minimum level of pulmonary reserve as ≤ Grade 1 dyspnea and oxygen saturation \> 91% on room air;
• International normalized ratio (INR) ≤ 1.5 ULN and activated partial thromboplastin time (APTT) ≤ 1.5 ULN.
• Vascular conditions for apheresis.

You may not qualify if:

• Active Central Nervous System (CNS) involvement by malignancy.
• Isolated extra-medullary disease relapse.
• Patients who received chemotherapy within 2 weeks before CNCT19 infusion. The following situations are excluded:
• Lymphodepleting Chemotherapy prescribed by the protocol;
• Tyrosine kinase inhibitors (TKI) and hydroxyurea must be stopped \> 72 hours prior to CNCT19 infusion;
• The following drugs must be stopped \> 1 week prior to CNCT19 infusion: 6-mercaptopurine, 6-thioguanine, methotrexate (\<25 mg / m2), cytosine arabinoside (\<100 mg / m2 / d), vincristine, asparaginase;
• CNS prophylaxis treatment must be stopped \> 1 week prior to CNCT19 infusion;
• Pegylated-asparaginase must be stopped \> 4 weeks prior to CNCT19 infusion.
• Radiotherapy before CNCT19 infusion:
• Non-CNS site of radiation completed \< 2 weeks prior to CNCT19 Infusion; CNS directed radiation completed \< 8 weeks prior to CNCT19 infusion.
• Therapeutic systemic doses of steroids were stopped \< 72 hours prior to CNCT19 infusion. However, the following physiological replacement doses of steroids are allowed: \< 10 mg/day hydrocortisone or equivalent.
• Has received anthracycline/anthraquinone drug treatment exceeding the maximum cumulative dose recommended by the guidelines, estimated by investigators before screening, as follows:
• Doxorubicin: 550mg/m2 (radiotherapy or combined medication, \<(radiotherapy or combined medication, \<350\~400 mg/m2);
• Epirubicin: 900\~1000 mg/m2 (Adriamycin used, \<800 mg/m2);
• Pirarubicin: 950 mg/m2;

Sponsors & Collaborators

• Juventas Cell Therapy Ltd.: lead

Study Sites (11)

Beijing Boren Hospital

Beijing, Beijing Municipality, 100000, China

RECRUITING

Xinqiao Hospital of TMMU

Chongqing, Chongqing Municipality, 400000, China

RECRUITING

Nanfang Hospital

Guangzhou, Guangdong, China

RECRUITING

Yanda hospital, Hebei medical university

Sanhe, Hebei, 065200, China

NOT YET RECRUITING

Henan Cancer Hospital

Zhengzhou, Henan, 450000, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

The affiliated hospital of Xuzhou medical university

Xuzhou, Jiangsu, 221006, China

RECRUITING

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, 200000, China

RECRUITING

West China Hospital，Sichuan University

Chengdu, Sichuan, 610000, China

RECRUITING

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

The First Affiliated Hospital, Zhejiang University school of Medicine

Hangzhou, Zhejiang, 310000, China

RECRUITING

Related Publications (2)

• Wang Y, Lv L, Song Y, Wei X, Zhou H, Liu Q, Xu K, Yan D, Zhang C, Liu S, Jin J, Mei H, Niu T, Liang A, Gu R, Ren J, Feng Y, Jin W, Zhou Y, Deng Y, Wang J. Inaticabtagene autoleucel in adult relapsed or refractory B-cell acute lymphoblastic leukemia. Blood Adv. 2025 Feb 25;9(4):836-843. doi: 10.1182/bloodadvances.2024014182.

  PMID: 39626300 DERIVED

• Shi Z, Zhu Y, Zhang J, Chen B. Monoclonal antibodies: new chance in the management of B-cell acute lymphoblastic leukemia. Hematology. 2022 Dec;27(1):642-652. doi: 10.1080/16078454.2022.2074704.

  PMID: 35622074 DERIVED

MeSH Terms

Conditions

Recurrence; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Jianxiang Wang, Dr.

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yan Zhou

CONTACT

+86-15010390127; zhouyan@juventas.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2020
• First Posted: December 24, 2020
• Study Start: December 24, 2020
• Primary Completion: September 22, 2022
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

CN (11)