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Acute Lymphoblastic LeukemiaEarly Phase 1NCT04689204

A Study of CTA30X Cell Injection in Patients With Relapsed or Refractory CD19-positive B-line Hematological Malignancies

A Early Phase 1 study testing CTA30X in people with Acute Lymphoblastic Leukemia and Non-hodgkin Lymphoma, run by He Huang at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

A study of CTA30X cell injection in the treatment of relapsed or refractory CD19-positive B-line hematological malignancies Read more about this study

Who is it for?
Ages 3 to 70 years
What is being tested?
CTA30X
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
1 siteChina
Study dates
29 Dec 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 and <70 years old;
  • 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;
  • Ineffective after first or multiple remedial treatments;
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  • 2 or more recurrences;
  • The number of primordial cells (lymphoblast and prolymphocyte) in bone marrow is >5% (morphology) and/or >1% (Flow cytometry);
  • Philadelphia-chromosome-negative (Ph-) patients; or Philadelphiachromosome-positive (Ph+) patients who cannot tolerate TKI treatments or do not respond to 2 TKI treatments;
  • Male or female aged ≥ 18 and <70 years old;
  • Histologically confirmed diagnosis per WHO Classification Criteria for Lymphocytic Tumors 2016, including DLBCL(NOS), follicular lymphoma, Chronic lymphoblastic leukemia/small lymphoblastic lymphoma transforms DLBCL, PMBCL and high grade B cell lymphoma;
  • Relapsed or refractory DLBCL (meeting one of the following conditions):
  • No remission or recurrence after receiving second-line or above chemotherapy;
  • Primary drug resistance;
  • Recurrence after autologous hematopoietic stem cell transplantation
  • Applicable standards for ALL and NHL:
  • Total bilirubin ≤ 51umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8umol/L;
  • Echocardiogram shows left ventricular ejection fraction (LVEF) ≥ 50%;
  • No active infection in the lungs, blood oxygen saturation by sucking air is ≥92%;
  • Estimated survival time ≥ 3 months;
  • ECOG performance status 0 to 2;

Who cannot join

  • Patients with extramedullary lesions, except those with CNSL (CNS-1) under effective control (for ALL patients only);
  • Confirmed diagnosis of lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/lymphoma per WHO Classification Criteria (for ALL patients only);
  • Patients with hereditary syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome (for ALL patients only);
  • Patients with intracranial extralateral lesions (cerebrospinal fluid tumor cells and/or intracranial lymphoma invasion shown by MRI) (for NHL patients only);
  • Extensive involvement of gastrointestinal lymphoma (for NHL patients only);
  • Radiotherapy, chemotherapy and monoclonal antibody within 1 week before screening;
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  • Have a history of allergy to any of the components in the cell products;
  • Prior treatment with any CAR T cell product or other genetically-modified T cell therapies;
  • According to the New York heart association (NYHA) cardiac function classification criteria, Subjects with grade III or IV cardiac insufficiency;
  • 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;
  • Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis).
  • 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;
  • Patients with autoimmune diseases requiring treatment, patients with immunodeficiency or requiring immunosuppressive therapy;
  • Patients with graft-versus-host disease (GVHD);
  • 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 infection;
  • Patients who have participated in any other clinical studies within 2 weeks prior to screening;
  • Pregnant and breast-feeding women and the subjects who are fertile and unable to take effective contraceptive measures (regardless of the gender);
  • Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital，College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: A Study of CTA30X Cell Injection in the Treatment of Relapsed or Refractory CD19-positive B-line Hematological Malignancies

A study of CTA30X cell injection in the treatment of relapsed or refractory CD19-positive B-line hematological malignancies

Read the detailed description

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD19+ B-line hematological malignancy: B-ALL and B-NHL. the selection of dose levels and the number of subjects are based on clinical tiral of similar foreign products. 3 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
CTA30X
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.

  • CTA30XDrug

    Also called CTA30X cell injection

    CTA30X cell injection by intravenous infusion

Study groups in NCT04689204
Study groupRoleWhat they receive
Administration of CTA30XExperimentalDose escalation follows the standard 3+3 dose escalation design. A total of 3 dose levels are set for subjects.
Receives: Drug: CTA30X

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 CTA30X infusion

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

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

    Measured: Up to 2 years after CTA30X infusion

Secondary outcomes (5)

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

    Assessment of ORR (ORR = CR + CRi ) at Month 1 and 3

    Measured: Month 1 and 3

  2. B-ALL, MRD negative overall response rate (MRD- ORR)

    Assessment of MRD negative overall response rate (MRD- ORR) at 3 months after CTA30X infusion

    Measured: 3 months

  3. B-ALL, ORR

    Assessment of ORR at Month 6, 12, 18 and 24

    Measured: Month 6, 12, 18 and 24

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

    From the first infusion of CTA30X to the occurrence of any event, including death, relapse or gene relapse, disease progression (any one occurs first), and the last visit

    Measured: Month 6, 12, 18 and 24

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

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

    Measured: weeks 4, 12, months 6, 12, 18 and 24

Timeline

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

  1. First posted30 Dec 2020
  2. Study start29 Dec 2020
  3. Primary completion29 Dec 2022
  4. Study completion31 May 2024

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
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04689204
Sponsor's protocol ID
BHCT-CTA30X-01
Status last verified
Jan 2025
First submitted
25 Dec 2020
Last updated
24 Jan 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CTA30X in people with Acute Lymphoblastic Leukemia and Non-hodgkin 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 21 inclusion and 23 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: finished, as of the sponsor's last update on 24 Jan 2025. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. 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 CTA30X 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 NCT04689204.

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 24 Jan 2025.

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