A Study of CT-RD06 Cell Injection in Patients With Relapsed or Refractory CD19+ B-cell Hematological Malignancy

NCT04226989 | Unknown Early Phase 1 DMC

• 1 other identifier: BHCT-CT-RD06-03
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

A study of CT-RD06 cell injection in patients with relapsed or refractory CD19+ B-cell hematological malignancy.

Conditions

Acute Lymphoblastic Leukemia; Non-Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (2)

• Dose-limiting toxicity (DLT)

  Adverse events assessed according to NCI-CTCAE v5.0 criteria

  Baseline up to 28 days after CT-RD06 infusion

• Incidence of treatment-emergent adverse events (TEAEs)

  Incidence of treatment-emergent adverse events \[Safety and Tolerability\]

  Up to 2 years after CT-RD06 infusion

Secondary Outcomes (5)

• B-cell acute lymphocytic leukemia(B-ALL), Overall response rate (ORR)

  At Month 1, 3, 6, 12, 18 and 24

• B-ALL, Overall survival (OS)

  Up to 2 years after CT-RD06 infusion

• B-ALL, Event-free survival (EFS)

  Up to 2 years after CT-RD06 infusion

• B cell non-hodgkin's lymphoma (B-NHL), Overall response rate (ORR)

  At Week 4, 12, and Month 6, 12, 18, 24

• B-NHL, disease control rate (DCR)

  At Week 12 and Month 6, 12, 18, 24

Study Arms (1)

Administration of CT-RD06

EXPERIMENTAL

Dose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.

Biological: CT-RD06

Interventions

CT-RD06 BIOLOGICAL

CT-RD06 cell injection by intravenous infusion

Also known as: CT-RD06 CAR-T cell injection

Administration of CT-RD06

Eligibility Criteria

• Age: 3 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 3-70 years;
• Histologically confirmed diagnosis of CD19+ B-ALL per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
• Relapsed or refractory CD19+ B-ALL (meeting one of the following conditions):
• CR not achieved after standardized chemotherapy;
• CR achieved following the first induction, but CR duration is ≤ 12 months;
• Ineffectively after first or multiple remedial treatments;
• or more relapses;
• The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is﹥5% (by morphology), and/or﹥1% (by flow cytometry);
• Philadelphia-chromosome-negative (Ph-) patients; or Philadelphia-chromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
• Male or female aged 18-70 years;
• Histologically confirmed diagnosis of DLBCL (NOS), FL, DLBCL transformed from CLL/SLL, PMBCL, and HGBCL per the WHO Classification Criteria for Lymphoma (2016);
• Relapsed or refractory B-NHL (meeting one of the following conditions):
• No response or relapse after second-line or above chemotherapy regimens;
• Primary drug resistance;
• Relapse after auto-HSCT;

You may not qualify if:

• Extramedullary lesions, except that CNSL (CNS-1) has been effectively controlled;
• Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/ lymphoma per WHO Classification Criteria;
• Hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome;
• Extranodal lesions in the brain (tumor cells in CSF, and/or MRI shows invasion of intracranial lymphoma);
• Extensive invasion of gastrointestinal lymphoma;
• History of hypersensitivity to any component of cell product;
• Prior treatment with any CAR T cell product or other genetically-modified T cell therapies;
• Prior treatment with radiotherapy, chemotherapy or mAb 1 week prior to apheresis;
• New York Heart Associate (NYHA) Class III/IV cardiac insufficiency (see Appendix 1);
• Myocardial infarction, cardioangioplasty or stenting, unstable angina pectoris, or other severe cardiac diseases within 12 months of enrollment;
• Severe primary or secondary hypertension of grade 3 or above (WHO Hypertension Guidelines, 1999);
• Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
• History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
• Severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
• Indwelling catheters in vivo (e.g. percutaneous nephrostomy, Foley catheter, bile duct catheter, or pleural/peritoneal/pericardial catheter). Ommaya storage, dedicated central venous access catheters such as Port-a-Cath or Hickman catheters are allowed;

Sponsors & Collaborators

• He Huang: lead
• Nanjing Bioheng Biotech Co., Ltd.: collaborator

Study Sites (1)

The First Hospital of Zhejiang Medical Colleage Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Lymphoma, Non-Hodgkin

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Lymphoma

Study Design

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

Study Record Dates

• First Submitted: January 8, 2020
• First Posted: January 13, 2020
• Study Start: February 5, 2020
• Primary Completion: February 5, 2022
• Study Completion: May 31, 2024
• Last Updated: February 21, 2020

Record last verified: 2020-02

Locations

CN (1)