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B-Cell Lymphoblastic Leukemia/LymphomaPhase 1/2NCT06503094

CD19 & CD20 Bispecific CAR T Cells for Relapsed / Refractory B Cell Hematological Tumors

A Phase 1/2 study testing CD19&CD20 bispecific CAR-T cells in people with B-Cell Lymphoblastic Leukemia/Lymphoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is a multi-center, open, prospective single-arm clinical study of patients with relapsed / refractory B cell hematological tumors to evaluate the safety and efficacy of CD19 \& CD20 bispecific CAR-T cells in relapsed / refractory B cell hematological tumors while collecting pharmacokinetics and… Read more about this study

Who is it for?
Ages 14 to 75 years
Conditions the study is for
B-Cell Lymphoblastic Leukemia/Lymphoma
What is being tested?
CD19&CD20 bispecific CAR-T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteChina
Study dates
14 Jan 2024to 18 Jun 2026
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 14 to 75 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Fully understand and voluntarily sign the informed consent form, and be willing and able to comply with the visit, treatment protocol, laboratory tests, and other study requirements specified in the flow sheet;
  • CD 19 + / CD 20 + B cell hematological tumor was confirmed by pathological and histological examination, and the patient met the following criteria for relapsed or refractory B cell hematological tumor:
  • Refractory / relapsed B lymphocytic leukemia (1 of the following 4 items can be met):
  • i . Recurrence within 6 months of first remission; ii. Primary refractory without complete remission after 2 cycles of standard chemotherapy regimen; iii. No complete remission or recurrence after first-line or multiline salvage chemotherapy; iv. Not eligible for HSCT conditions, abandonment of HSCT, or relapse after HSCT due to conditional limitations.
  • Refractory / relapsed B-cell lymphoma (meet the following item 1 of the first 4 items plus item 5):
  • i . After four courses of chemotherapy with a standard regimen, tumor shrinkage was less than 50% or disease progression; ii . CR after standard regimen chemotherapy, but relapsed within 6 months; iii.2 or more recurrences after CR; iv . Not suitable for hematopoietic stem cell transplantation, or abandoning HSCT due to conditional restrictions or relapse after hematopoietic stem cell transplantation; v . Subject must have received prior adequate treatment, including at least: a monoclonal antibody against CD 20 and combination chemotherapy containing an anthracycline drug agent.
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  • B-cell hematological tumors include the following 3 categories:
  • B-cell acute lymphoblastic leukemia (B-ALL);
  • Indolent B-cell lymphoma (CLL, FL, MZL, LPL, HCL);
  • Invasive B-cell lymphoma (DLBCL, BL, and MCL);
  • With measurable or evaluable lesions: Lymphoma patients require a single lesion 15mm or 2 or more lesions 10mm; patients with leukemia require persistent positive or positive recurrence of bone marrow MRD.
  • Subjects with the Eastern Cooperative Oncology Group (ECOG) fitness scores of 0 to 2.
  • The results of FCM or immunohistochemical detection of tumor antigen (CD 19 / CD 20) were positive.
  • The estimated survival period is more than 3 months starting from the signing of the informed consent form.

Who cannot join

  • Appearance of one of the following cardiac criteria: atrial fibrillation; myocardial infarction in the last 12 months; prolonged QT syndrome or secondary QT extension, as judged by the investigator. Echocardiography LVSF <30% or LVEF <50%; clinically significant pericardial effusion; cardiac insufficiency NYHA (New York Heart Association) III or IV (confirmed by echocardiography within 12 months of treatment).
  • Active GVHD.
  • History of severe pulmonary function impairment disease.
  • Other malignant tumors in the advanced stage.
  • Severe infection or persistent infection that cannot be effectively controlled.
  • Combined with severe autoimmune disease or innate immune deficiency.
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  • Active hepatitis (hepatitis B virus deoxyribonucleic acid [HBV-DNA 500 IU / ml and abnormal liver function] or hepatitis C antibody [HCV-Ab] positive, HCV-RNA above the lower limit of detection of the analytical method and abnormal liver function).
  • Human immunodeficiency virus (HIV) infection or syphilis infection.
  • History of severe allergies to biological products (including antibiotics).
  • There are central nervous system disorders, such as uncontrolled epilepsy, cerebrovascular ischemia/hemorrhage, dementia, cerebellar diseases, etc..
  • Female patients are in pregnancy and lactation, or have a pregnancy plan within 12 months.
  • situations where the investigator may increase the risk or interfere with the test results.

Trial locations and contacts

1 site in 1 country.

Mei Heng, M.D., Ph.D contact

027-8572600

hmei@hust.edu.cn

Yun Kang contact

17362995329

cloudykang@hust.edu.cn

China1 site, 1 recruiting

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, Hubei, 430022

    Mei Heng, M.D., Ph.D, hmei@hust.edu.cn

    Recruiting

Other trials in China

About this study

Official title: The Safety and Efficacy of CD19 & CD20 Bispecific CAR T Cells in Treating Relapsed / Refractory B Cell Hematological Tumors

This study is a multi-center, open, prospective single-arm clinical study of patients with relapsed / refractory B cell hematological tumors to evaluate the safety and efficacy of CD19 \& CD20 bispecific CAR-T cells in relapsed / refractory B cell hematological tumors while collecting pharmacokinetics and pharmacodynamics indicators of CAR-T cells.

Read the detailed description

Since 2010, CAR-T ( chimeric antigen receptor T cell) therapy has shown good results in tumor treatment and has achieved positive clinical therapeutic effects in hematological tumors. The structure of the dual-target CAR-T of CD19 \& CD20 is designed with a 4-1BB costimulatory domain and an antigenic recognition region with a tandem structural sequence to recognize CD20 or CD19 by a single structure. CD19 \& CD20 bispecific CAR-T cells can identify CD 19 or CD 20 with the advantage that the single target CAR-T does not have, reducing the possibility of target loss. The structure has been optimized to enhance the safety to treat B cell-derived hematological tumors (at least CD19 positive or CD20 positive).

Being tested
CD19&CD20 bispecific CAR-T cells
Keywords
CAR-T, dual-target, Relapsed / Refractory B Cell Hematological Tumors
Medical subject headings
Burkitt Lymphoma, Lymphoma, Recurrence

What participants receive

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

  • CD19&CD20 bispecific CAR-T cellsDrug

    Each patient will receive CD19\&CD20 bispecificCAR-T cells by intravenous infusion on day 0.

Study groups in NCT06503094
Study groupRoleWhat they receive
Effective of CD19&CD20 bispecific CAR-T cellsExperimentalThe infusion dose range of cells in this trial is recommended: 2 to 6 10^6 And CAR-T cells / kg.
Receives: Drug: CD19&CD20 bispecific CAR-T cells

What is being measured

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

  1. Overall response rate (ORR) of administering CD19&CD20 dual-target CAR-T cells In the treatment of relapsed/refractory B-cell hematologic tumors

    Disease overall response rate (ORR) will be assessed from CAR-T cell infusion to death or last follow-up (censored).

    Measured: within 3 years after infusion

  2. Incidence of Treatment-related Adverse Events

    Therapy-related adverse events (AE), including severe adverse events (SAE) and laboratory outliers with clinical significance, will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0).

    Measured: within 3 years after infusion

  3. Complete response rate (CR) of administering CD19&CD20 dual-target CAR-T cells In the treatment of relapsed/refractory B-cell hematologic tumors

    CR will be assessed from CAR-T cell infusion to death or last follow-up (censored).

    Measured: within 3 years after infusion

  4. Partial response rate (PR) of administering CD19&CD20 dual-target CAR-T cells In the treatment of relapsed/refractory B-cell hematologic tumors

    PR will be assessed from CAR-T cell infusion to death or last follow-up.

    Measured: within 3 year after infusion

Secondary outcomes (3)

  1. Overall survival (OS) of administering CD19&CD20 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell hematologic tumors

    OS will be assessed from CAR-T cell infusion to death or last follow-up (censored).

    Measured: within 3 years after infusion

  2. Progress-free survival (PFS) of administering CD19&CD20 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell hematologic tumors

    PFS will be assessed from CAR-T cell infusion to death or last follow-up (censored).

    Measured: within 3 years after infusion

  3. Event-free survival (EFS) of administering CD19&CD20 dual-target CAR-T cells in the treatment of relapsed/refractory B-cell hematologic tumors

    EFS will be assessed from CAR-T cell infusion to death or last follow-up (censored).

    Measured: within 3 years after infusion

Timeline

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

  1. First posted16 Jul 2024
  2. Study start14 Jan 2024
  3. Primary completion18 Dec 2025 (estimated)
  4. Study completion18 Jun 2026 (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
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06503094
Sponsor's protocol ID
CD19 & CD20 bispecific CAR T
Status last verified
Jul 2024
First submitted
17 Jun 2024
Last updated
16 Jul 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lee DW, Kochenderfer JN, Stetler-Stevenson M, Cui YK, Delbrook C, Feldman SA, Fry TJ, Orentas R, Sabatino M, Shah NN, Steinberg SM, Stroncek D, Tschernia N, Yuan C, Zhang H, Zhang L, Rosenberg SA, Wayne AS, Mackall CL. T cells expressing CD19 chimeric antigen receptors for acute lymphoblastic leukaemia in children and young adults: a phase 1 dose-escalation trial. Lancet. 2015 Feb 7;385(9967):517-528. doi: 10.1016/S0140-6736(14)61403-3. Epub 2014 Oct 13.

    PubMed 25319501

  • Ali SA, Shi V, Maric I, Wang M, Stroncek DF, Rose JJ, Brudno JN, Stetler-Stevenson M, Feldman SA, Hansen BG, Fellowes VS, Hakim FT, Gress RE, Kochenderfer JN. T cells expressing an anti-B-cell maturation antigen chimeric antigen receptor cause remissions of multiple myeloma. Blood. 2016 Sep 29;128(13):1688-700. doi: 10.1182/blood-2016-04-711903. Epub 2016 Jul 13.

    PubMed 27412889

  • Khalil DN, Smith EL, Brentjens RJ, Wolchok JD. The future of cancer treatment: immunomodulation, CARs and combination immunotherapy. Nat Rev Clin Oncol. 2016 May;13(5):273-90. doi: 10.1038/nrclinonc.2016.25. Epub 2016 Mar 15.

    PubMed 26977780

  • Maude SL, Frey N, Shaw PA, Aplenc R, Barrett DM, Bunin NJ, Chew A, Gonzalez VE, Zheng Z, Lacey SF, Mahnke YD, Melenhorst JJ, Rheingold SR, Shen A, Teachey DT, Levine BL, June CH, Porter DL, Grupp SA. Chimeric antigen receptor T cells for sustained remissions in leukemia. N Engl J Med. 2014 Oct 16;371(16):1507-17. doi: 10.1056/NEJMoa1407222.

    PubMed 25317870

  • Cohen AD, Garfall AL, Stadtmauer EA, Melenhorst JJ, Lacey SF, Lancaster E, Vogl DT, Weiss BM, Dengel K, Nelson A, Plesa G, Chen F, Davis MM, Hwang WT, Young RM, Brogdon JL, Isaacs R, Pruteanu-Malinici I, Siegel DL, Levine BL, June CH, Milone MC. B cell maturation antigen-specific CAR T cells are clinically active in multiple myeloma. J Clin Invest. 2019 Mar 21;129(6):2210-2221. doi: 10.1172/JCI126397.

    PubMed 30896447

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CD19&CD20 bispecific CAR-T cells in people with B-Cell Lymphoblastic Leukemia/Lymphoma, run by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology 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 14 inclusion and 12 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 16 Jul 2024. 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 Mei Heng, M.D., Ph.D (027-8572600, hmei@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall response rate (ORR) of administering CD19&CD20 dual-target CAR-T cells In the treatment of relapsed/refractory B-cell hematologic tumors (time frame: within 3 years after infusion). The study lists 4 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 NCT06503094, which also lists 5 linked publications.

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 16 Jul 2024.

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