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Relapsed and RefractoryPhase 1/2NCT04626908

Clinical Study of Targeting CD19 and CD22 Chimeric Antigen Receptor T Lymphocytes in the Treatment of Recurrent or Refractory B Cell Non-Hodgkin Lymphoma

A Phase 1/2 study testing GC022F CAR-T cells in people with Relapsed and Refractory and Lymphoid Hematological Malignancies, 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Clinical Study of Targeting CD19 and CD22 Chimeric Antigen Receptor T Lymphocytes in the Treatment of Recurrent or Refractory B Cell Non-Hodgkin Lymphoma Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
GC022F CAR-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
20 Nov 2020to 30 Jun 2023
Phase
Phase 1/2
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, 18-75 years old (including the threshold value);
  • Histologically confirmed as diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma (TFL), or primary mediastinal B-cell lymphoma (PMBCL) :
  • Refractory B-NHL: PD was the optimal response to standard first-line treatment (those with intolerance to first-line treatment were not included in this study); Or SD after at least 4 courses of first-line treatment, and the DURATION of SD shall not exceed 6 months after the last treatment; Or the subjects' best response to the last treatment of second-line or above treatment is PD, or SD after at least 2 courses of second-line or above treatment, and the SD maintenance time is not more than 6 months; Or:
  • Relapsed B-NHL: after standard systemic treatment and complete remission after second-line treatment, the disease recurred as certified by histopathology, or the recurrence as confirmed by histopathology within 1 year after autologous hematopoietic stem cell transplantation (not limited by previous treatment methods);
  • Patients with INVERt follicular lymphoma must receive chemotherapy prior to transformation and meet the above definition of recurrent or refractory after transformation;
  • according to Lugano treatment response standard (2014 version), there should be at least one evaluable tumor lesion: the longest diameter of the injunctional lesion was > 1.5cm, and the longest diameter of the injunctional lesion was b> 1.0cm;
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  • Positive expression of CD19 and CD22 in biopsy sections of tumor tissues;
  • Patients who have failed or relapsed after single-target CAR-T therapy may also be enrolled.
  • Prior to the study, the approved anti-B-NHL treatment, such as systemic chemotherapy, general radiotherapy and immunotherapy, has been completed for at least 2 weeks;
  • ECOG≤1；
  • Expected survival ≥3 months;
  • Absolute count of neutrophils ≥ 1×109/L;
  • Platelet count ≥50×109/L;
  • Absolute lymphocyte count ≥1×108/L;
  • Adequate organ function reserve:
  • ALANINE aminotransferase and aspartate aminotransferase ≤ 2.5× UNL (upper limit of normal value);
  • Creatinine clearance rate (Cockcroft-Gault method) ≥60 mL/min;
  • Serum total bilirubin ≤1.5× UNL;
  • The left ventricular ejection fraction (LVEF) of the subject was diagnosed by echocardiography ≥50%, and no clinically significant pericardial effusion was observed, and no clinically significant ecg abnormalities were observed;
  • under natural indoor air environment, the basic oxygen saturation of > is 92%;
  • Vein access required for collection can be established, and there are no contraindications for leukocyte collection;
  • Women of childbearing age had negative pregnancy test during screening period and before administration, and agreed to take effective contraceptive measures at least one year after infusion; male subjects with fertile partners must agree to use effective barrier contraceptive method at least one year after infusion and avoid sperm donation;
  • Voluntary signing of informed consent.

Who cannot join

  • Other tumors (except cured non melanoma skin cancer, cervical cancer in situ, superficial bladder cancer, breast ductal carcinoma in situ, or other malignant tumors with complete remission for more than 5 years);
  • Persons with severe mental disorders;
  • A history of hereditary diseases such as Fanconi anemia, Schrader syndrome, Costerman syndrome, or any other known bone marrow failure syndrome;
  • A history of allogeneic stem cell transplantation;
  • Heart disease with grade III-IV heart failure [New York Heart Association (NYHA) classification] or myocardial infarction, cardiac angioplasty or stenting, unstable angina pectoris, or other clinically significant cardiac conditions within the year prior to enrollment;
  • The presence of any indwelling catheter or drainage tube (e.g., percutaneous nephrostomy tube, bile drainage tube or pleural/peritoneal/pericardial catheter), allowing the use of a dedicated central venous catheter;
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  • Subjects with a history of CNS lymphoma, cerebrospinal fluid malignant cells or brain metastasis;
  • A history or disease of the central nervous system, such as seizure disorder, cerebral ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease involving CNS;
  • The results of any of the following virology-ELISA tests were positive: HIV antibody, HCV antibody, TPPA, hepatitis B surface antigen;
  • There were active infections requiring systematic treatment within 2 weeks before single collection;
  • Persons with a known severe allergic reaction to cyclophosphamide or fludarabine, or with an allergic constitution;
  • A history of an autoimmune disease (e.g., Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus) that has caused injury to the terminal organs or requires systemic immunosuppressive/disease-modulating drugs within the past 2 years;
  • Pulmonary fibrosis is present;
  • Has received treatment in another clinical trial within 4 weeks prior to participation in this trial, or the date of signing of the informed consent is within 5 half-lives (whichever is longer) of the last medication used in the last other clinical trial;
  • Poor compliance due to physiological, family, social, geographical and other factors, unable to comply with the research program and follow-up plan;
  • The presence of a comorbiditie requiring systemic corticosteroid therapy (≥5 mg/ day of prednisone or equivalent dose of other corticosteroids) or other immunosuppressive agents within 6 months of study treatment was determined by the investigator;
  • Lactating women who do not want to stop breastfeeding;
  • Any other condition that the researcher considers inappropriate to be included in the study.

Trial locations and contacts

1 site in 1 country.

He Huang, MD contact

86-13605714822

hehuangyu@126.com

Yongxian Hu, MD contact

86-15957162012

huyongxian2000@aliyun.com

China1 site

  • The first affiliated hospital of medical college of zhejiang university

    Hangzhou, Zhejiang, 310003

    He Huang, MD, 86-13605714822, hehuangyu@126.com

Other trials in China

About this study

Clinical Study of Targeting CD19 and CD22 Chimeric Antigen Receptor T Lymphocytes in the Treatment of Recurrent or Refractory B Cell Non-Hodgkin Lymphoma

Read the detailed description

This is a single-arm, single-center, open clinical study to evaluate the safety and efficacy of GC022F injection in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma.

Being tested
GC022F CAR-T cells
Keywords
lymphoid hematological malignancies, CAR-T cell therapy, CD19, CD22
Medical subject headings
Recurrence

What participants receive

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

  • GC022F CAR-T cellsDrug

    Also called GC022F CAR-T cells injection

    Each subject receive GC022F CAR-T cells by intravenous infusion

Study groups in NCT04626908
Study groupRoleWhat they receive
Administration of GC022F CAR-T cellsExperimentalEach subject receive GC022F CAR T-cells by intravenous infusion
Receives: Drug: GC022F CAR-T cells

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    Proportion of patients with dose limiting toxicity (DLT) after cell infusion

    Measured: Within 28 days after cell infusion

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

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

    Measured: 24 months after cell infusion

Secondary outcomes (4)

  1. Overall response rate(ORR)

    Assessment of ORR (ORR = CR + CRi ) at Month 1,3,6,12,18and 24

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

  2. Progression-free survival (PFS)

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

    Measured: Month 6,12,18and 24

  3. Overall survival (OS)

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

    Measured: Month 6,12,18and 24

  4. Duration of response(DOR)

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

    Measured: Month 6,12,18and 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 Nov 2020
  2. Study start20 Nov 2020 (estimated)
  3. Primary completion30 Jun 2022 (estimated)
  4. Study completion30 Jun 2023 (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
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04626908
Sponsor's protocol ID
GC022F-ZhejiangU
Status last verified
Nov 2020
First submitted
3 Nov 2020
Last updated
13 Nov 2020
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 Phase 1/2 study testing GC022F CAR-T cells in people with Relapsed and Refractory and Lymphoid Hematological Malignancies, 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 23 inclusion and 18 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 13 Nov 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Contact He Huang, MD (86-13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: Within 28 days after cell 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 NCT04626908.

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 13 Nov 2020.

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