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Acute Lymphoblastic LeukemiaEarly Phase 1NCT04226989

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

A Early Phase 1 study testing CT-RD06 in people with Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma, run by He Huang at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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

Who is it for?
Ages 3 to 70 years
What is being tested?
CT-RD06
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
1 siteChina
Study dates
5 Feb 2020to 31 May 2024
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 3 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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;
Show all 50Show fewer
  • 2 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;
  • At least one assessable tumor lesion per Lugano 2014 criteria;
  • Common inclusion criteria for B-ALL and B-NHL:
  • Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L;
  • Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
  • No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%;
  • Estimated survival time ≥ 3 months;
  • ECOG performance status 0 to 2;
  • Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
  • 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;
  • Common exclusion criteria for B-ALL and B-NHL:
  • 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;
  • History of other primary cancer, except for the following conditions:
  • Cured non-melanoma after resection, such as basal cell carcinoma of the skin;
  • Cervical cancer in situ, localized prostate cancer, ductal cancer in situ with disease-free survival ≥ 2 years after adequate treatment;
  • Autoimmune diseases requiring treatment, immunodeficiency or patients requiring immunosuppressive therapy;
  • Prior immunizations with live vaccine 4 weeks prior to screening;
  • History of alcoholism, drug abuse or mental illness;
  • If HBsAg positive at screening, HBV DNA copy number detected by PCR in patients with active hepatitis B > 1000 (if HBV DNA copy number≤1000, routine antiviral therapy is required after enrollment), as well as CMV, hepatitis C, syphilis and HIV infection;
  • Concurrent therapy with systemic steroids within 1 week prior to screening, except for the patients recently or currently receiving inhaled steroids;
  • Patients who have participated in any other clinical studies within 2 weeks prior to screening;
  • Female pregnant or lactating, male for female fertile but unable to take medically acceptable contraception measures;
  • Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

China1 site, 1 recruiting

  • The First Hospital of Zhejiang Medical Colleage Zhejiang University

    Hangzhou, Zhejiang, 310003

    He Huang, MD, 86-13605714822, hehuangyuzj@163.com

    Jimin Shi, MD, 86-13857119907, jiminshi@126.com

    Recruiting

Other trials in China

About this study

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

Read the detailed description

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-cell hematological malignancy: B-ALL and B-NHL, the selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 2 groups of patients will be enrolled, 36 in each group. Primary objective is to explore the safety, main consideration is dose-related safety.

Being tested
CT-RD06
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CT-RD06Biological

    Also called CT-RD06 CAR-T cell injection

    CT-RD06 cell injection by intravenous infusion

Study groups in NCT04226989
Study groupRoleWhat they receive
Administration of CT-RD06ExperimentalDose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
Receives: Biological: CT-RD06

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicity (DLT)

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

    Measured: Baseline up to 28 days after CT-RD06 infusion

  2. Incidence of treatment-emergent adverse events (TEAEs)

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

    Measured: Up to 2 years after CT-RD06 infusion

Secondary outcomes (5)

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

    Assessment of ORR (ORR = CR + CRi ) at Month 6, 12, 18 and 24

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

  2. B-ALL, Overall survival (OS)

    From the first infusion of CT-RD06 to death or the last visit

    Measured: Up to 2 years after CT-RD06 infusion

  3. B-ALL, Event-free survival (EFS)

    From the first infusion of CT-RD06 to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit

    Measured: Up to 2 years after CT-RD06 infusion

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

    Assessment of ORR (ORR = CR + PR) per Lugano 2014 criteria

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

  5. B-NHL, disease control rate (DCR)

    Assessment of DCR (DCR=CR+PR+SD) per Lugano 2014 criteria

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jan 2020
  2. Study start5 Feb 2020
  3. Primary completion5 Feb 2022 (estimated)
  4. Study completion31 May 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
72 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04226989
Sponsor's protocol ID
BHCT-CT-RD06-03
Status last verified
Feb 2020
First submitted
8 Jan 2020
Last updated
21 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CT-RD06 in people with Acute Lymphoblastic Leukemia and Non-Hodgkin's Lymphoma, run by He Huang at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 50 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: Baseline up to 28 days after CT-RD06 infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04226989.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2020.

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