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B-cell LymphomaEarly Phase 1NCT05015972

UCAR-T for CD19+ Refractory/Relapsed B Hematologic Malignancies

A Early Phase 1 study testing CTA30X UCAR-T injection in people with B-cell Lymphoma, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China at 1 site in China.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This is a single arm, open-label, single-center prospective study to determinethe safety and efficacy of CTA30X UCAR-T cells in patients diagnosed with CD19+ refractory/relapsed B Hematologic Malignancies Read more about this study

Who is it for?
Ages 3 to 70 years
Conditions the study is for
B-cell Lymphoma
What is being tested?
CTA30X UCAR-T injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteChina
Study dates
20 Aug 2021to 31 Dec 2023
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

  • Age ≥3 and < 70 years old, gender is not limited;
  • Patients with a histologic diagnosis of CD19+ B-ALL according to the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Lymphoblastic Leukemia (2016.v1);
  • Meet the R/R CD19+ B-ALL diagnosis, including any of the following conditions:
  • No CR after standard chemotherapy; B) CR was induced for the first time, but the duration of CR was less than 12 months; C) R/R CD19+ B-ALL that failed after the first or repeated remedial therapy; D) 2 or more recurrences;
  • Number of primary cells (primary + juvenile) in bone marrow, > 5% (morphology) and/or > 1% (flow cytometry);
  • Philadelphia chromosomal negative (PH -) subjects;Philadelphia chromosomal positive (pH +) subjects who either cannot tolerate or do not respond to either of the TKI treatments;
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  • Age ≥18 years old and < 70 years old, regardless of gender;
  • According to the 2016 WHO classification criteria for lymphocytic tumors, the histological diagnosis included: DLBCL (NOS);Subjects with follicular lymphoma, chronic lymphocytic leukemia/small lymphocytic lymphoma transformation, and PMBCL and high-grade B-cell lymphoma;
  • Relapsed or refractory B-NHL (meets one of the following conditions) :
  • Subjects have no remission or recurrence after receiving second-line chemotherapy regimen or above; B) primary drug resistance; C) Subjects relapse after autologous hematopoietic stem cell transplantation;
  • According to Lugano 2014 criteria, there should be at least one evaluable tumor focus;
  • Common standards for ALL and NHL:
  • Serum total bilirubin ≤51 umol/L, serum ALT and AST ≤ 3 times of the upper limit of the normal range, serum creatinine ≤176.8 umol /L;
  • Echocardiography showed left ventricular ejection fraction (LVEF) ≥50%;
  • Subjects have no active pulmonary infection, and oxygen saturation of suction finger vein is ≥92%;
  • The estimated survival time is more than 3 months;
  • ECOG score 0-2;
  • Subjects or their legal guardians participate in this study voluntarily and sign the informed consent.

Who cannot join

  • Extramedullary lesions, except those with effectively controlled CNSL (CNS-1);(All patients only)
  • A lymphoblastic crisis of chronic myeloid leukemia, Burkitt's leukemia/lymphoma, was diagnosed according to WHO classification;(All patients only)
  • having a genetic syndrome such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome;(All patients only)
  • Extranodal intracranial lesions (tumor cells in CSF and/or intracranial lymphoma shown on MRI);(For patients with NHL only)
  • subjects with extensive gastrointestinal lymphoma invasion;(For patients with NHL only)
  • Subjects received radiotherapy, chemotherapy and monoclonal antibody treatment within 1 week before screening;
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  • Have a history of allergy to any one ingredient in cell products;
  • Prior use of any CAR T cell product or other genetically modified T cell therapy
  • Subjects with cardiac dysfunction grade III or IV according to the New York Heart Association (NYHA) cardiac function classification standards;
  • Myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris or other clinically serious heart disease within 12 months of enrollment;
  • Severe primary or secondary hypertension of grade 3 or higher (WHO Hypertension Guidelines, 1999);
  • Patients with prolonged QT interval indicated by ECG and previous severe heart disease such as severe arrhythmia;
  • Previous history of craniocerebral trauma, disturbance of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.
  • Severe active infection (except simple urinary tract infection and bacterial pharyngitis);
  • Subject has a history of other primary cancers except for:
  • Non-melanoma cured by excision, such as basal cell carcinoma of the skin; B. Cervical carcinoma in situ, local prostate cancer, and ductal carcinoma in situ with disease-free survival ≥2 years after adequate treatment;
  • Subjects with autoimmune diseases requiring treatment or subjects requiring immunosuppressive therapy;
  • Patients with graft-versus-host disease (GVHD) and/or requiring immunosuppressive therapy;
  • Live vaccine inoculation within 4 weeks before screening;
  • Subjects have a history of alcohol, drug abuse or mental illness;
  • During screening, if the subjects were HBV surface antigen positive, they were tested by active hepatitis B PCR. If HBV DNA copy number > 1000, they were excluded; if HBV DNA copy number ≤1000, routine antiviral treatment was required after enlistment).Hepatitis C, syphilis antibody positive, syphilis virus DNA test exceeded the upper limit of normal value and CMV virus DNA test exceeded the upper limit of normal value;
  • Subjects who were receiving systemic steroid therapy prior to screening and were determined by the investigator to require long-term systemic steroid therapy during the treatment period (other than inhalation or topical use);
  • Screening participants who had participated in other clinical trials within the previous 2 weeks;
  • Pregnant and lactating women and fertile subjects who are unable to take effective contraceptive measures (both male and female);
  • Any situation that the investigator believes may increase the risk to the subject or interfere with the outcome of the study.

Trial locations and contacts

1 site in 1 country.

China1 site

  • No.212 Daguan Road, Xishan District

    Kunming, Yunnan

Other trials in China

About this study

Official title: A Study of CTA30X UCAR-T Cell Injection in the Treatment of Patients With r/r CD19+ B Hematologic Malignancies

This is a single arm, open-label, single-center prospective study to determinethe safety and efficacy of CTA30X UCAR-T cells in patients diagnosed with CD19+ refractory/relapsed B Hematologic Malignancies

Read the detailed description

The main aim of the study is to determine the safety and efficacy of CTA30X UCAR-T in R/R B Hematologic Malignancies. CTA30X UCAR-T is an allogeneic chimeric antigenreceptor T-cell (CAR-T) therapy that targets CD19 and B-cell Hematologic Malignancies. The study will include 72 subjects to receive CTA30X UCAR-T singleinfusion.

Conditions
B-cell Lymphoma
Being tested
CTA30X UCAR-T injection
Keywords
UCAR-T, allogeneic, CD19, B-ALL, B-NHL
Medical subject headings
Lymphoma, B-Cell

What participants receive

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

  • CTA30X UCAR-T injectionBiological

    CTA30X UCAR-T injection is an allogeneic CAR-Ttargeted CD19 . A single infusion of CART cells will be administered intravenously.

Study groups in NCT05015972
Study groupRoleWhat they receive
CTA30X UCAR-T treatmentExperimentalCD19+ R/R B Hematologic Malignancies patients be treated with a single dose of CTA30X UCAR-T cells. Total dose of(5-30)*10E6/kg cells will be administered at Day 0
Receives: Biological: CTA30X UCAR-T injection

What is being measured

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

  1. Dose limiting toxicity

    CRS lasting ≥7 days G3 or ≥G4 after CTA30X infusion;

    Measured: Up to 24 weeks after CAR-T infusion

  2. Incidence of AE after CAR-T infusion

    Incidence of adverse events after CTA30X UCAR-T infusion

    Measured: Up to 4 weeks after the infusion of CAR-T cells

Secondary outcomes (7)

  1. ORR rate

    Overall response rate (ORR=CR+CRi) after CTA30X UCAR-T infusion

    Measured: 1month, 3months after CTA30X UCAR-T infusion

  2. MRD-ORR

    The overall response rate was MRD negative within 3 months after treatment

    Measured: within 3months after CTA30X UCAR-T infusion

  3. BOR

    The best overall response within 3 months after treatment

    Measured: within 3months after CTA30X UCAR-T infusion

  4. DOR

    Duration of remission

    Measured: From the onset of a tumor from the first assessment of CR or PR up to 1 year

  5. ORR

    ORR=CR+CRi

    Measured: 6month, 12months、 18months and24months after CTA30X UCAR-T infusion

  6. EFS

    Event-free survival

    Measured: 6month, 12months、 18months and24months after CTA30X UCAR-T infusion

  7. OS

    Overall survival

    Measured: 6month, 12months、 18months and24months after CTA30X UCAR-T infusion

Timeline

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

  1. First posted23 Aug 2021
  2. Study start20 Aug 2021 (estimated)
  3. Primary completion30 Jun 2023 (estimated)
  4. Study completion31 Dec 2023 (estimated)

Why it stopped: No proper participant is found.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05015972
Sponsor's protocol ID
CTA30X
Status last verified
Nov 2022
First submitted
21 Apr 2021
Last updated
29 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing CTA30X UCAR-T injection in people with B-cell Lymphoma, run by 920th Hospital of Joint Logistics Support Force of People's Liberation Army of China 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 18 inclusion and 25 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: withdrawn, as of the sponsor's last update on 29 Nov 2022. 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 was withdrawn before enrolling participants, so there are no results.

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 (time frame: Up to 24 weeks after CAR-T 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 NCT05015972.

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 29 Nov 2022.

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