CD19 & CD22 Bispecific CAR T Cells in the Treatment of Relapsed/Refractory B Cell Hematologic Tumors
NCT ID: NCT06735495
Last Updated: 2024-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
80 participants
INTERVENTIONAL
2024-11-04
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Effective of CD19&CD22 bispecific CAR-T cells
The infusion dose range of cells in this trial is recommended: 1 to 2 10\^6 And CAR-T cells / kg.
CD19&CD22 bispecific CAR-T cells
Each patient will receive CD19\&CD22 bispecific CAR-T cells by intravenous infusion on day 0
Interventions
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CD19&CD22 bispecific CAR-T cells
Each patient will receive CD19\&CD22 bispecific CAR-T cells by intravenous infusion on day 0
Eligibility Criteria
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Inclusion Criteria
1. 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.
2. 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.
2.The results of FCM or immunohistochemical detection of tumor antigen (CD 19 / CD 22) were positive.
3.The estimated survival period is more than 3 months starting from the signing of the informed consent form.
4.Good organ function,Meet the following requirements：
1. HGB≥70g/L(transfusible)
2. Liver and kidney function: creatinine ≤1.5XULN: total bilirubin ≤1.5XULN:ALT and AST≤2.5X ULN
3. Cardiopulmonary function: left ventricular ejection fraction \>50%; Blood oxygen saturation \>90%;
5.Subjects with the Eastern Cooperative Oncology Group (ECOG) fitness scores of 0 to 2.
Exclusion Criteria
2. History of severe pulmonary function impairment disease.
3. Other malignant tumors in the advanced stage.
4. Severe infection or persistent infection that cannot be effectively controlled.
5. Combined with severe autoimmune disease or innate immune deficiency.
6. 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).
7. Human immunodeficiency virus (HIV) infection or syphilis infection.
8. History of severe allergies to biological products (including antibiotics).
9. Acute graft-versus-host response (GVHD) allogeneic hematopoietic stem remained one month after immunosuppressant discontinuation.
10. Patients who have other serious physical or mental illnesses or abnormalities in laboratory tests that may increase the risk of participating in the clinical trial or interfere with the study results, and who are deemed unsuitable for participation in the clinical trial by the investigator
3 Years
75 Years
ALL
No
Sponsors
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Hebei Taihe Chunyu Biotechnology Co., Ltd
INDUSTRY
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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MEI HENG
Proferssor, Cheif Doctor
Principal Investigators
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Heng Mei, M.D., Ph.D
Role: PRINCIPAL_INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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Mei Heng, M.D., Ph.D
Role: primary
References
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Frank MJ, Baird JH, Kramer AM, Srinagesh HK, Patel S, Brown AK, Oak JS, Younes SF, Natkunam Y, Hamilton MP, Su YJ, Agarwal N, Chinnasamy H, Egeler E, Mavroukakis S, Feldman SA, Sahaf B, Mackall CL, Muffly L, Miklos DB; CARdinal-22 Investigator group. CD22-directed CAR T-cell therapy for large B-cell lymphomas progressing after CD19-directed CAR T-cell therapy: a dose-finding phase 1 study. Lancet. 2024 Jul 27;404(10450):353-363. doi: 10.1016/S0140-6736(24)00746-3. Epub 2024 Jul 9.
Spiegel JY, Patel S, Muffly L, Hossain NM, Oak J, Baird JH, Frank MJ, Shiraz P, Sahaf B, Craig J, Iglesias M, Younes S, Natkunam Y, Ozawa MG, Yang E, Tamaresis J, Chinnasamy H, Ehlinger Z, Reynolds W, Lynn R, Rotiroti MC, Gkitsas N, Arai S, Johnston L, Lowsky R, Majzner RG, Meyer E, Negrin RS, Rezvani AR, Sidana S, Shizuru J, Weng WK, Mullins C, Jacob A, Kirsch I, Bazzano M, Zhou J, Mackay S, Bornheimer SJ, Schultz L, Ramakrishna S, Davis KL, Kong KA, Shah NN, Qin H, Fry T, Feldman S, Mackall CL, Miklos DB. CAR T cells with dual targeting of CD19 and CD22 in adult patients with recurrent or refractory B cell malignancies: a phase 1 trial. Nat Med. 2021 Aug;27(8):1419-1431. doi: 10.1038/s41591-021-01436-0. Epub 2021 Jul 26.
Fry TJ, Shah NN, Orentas RJ, Stetler-Stevenson M, Yuan CM, Ramakrishna S, Wolters P, Martin S, Delbrook C, Yates B, Shalabi H, Fountaine TJ, Shern JF, Majzner RG, Stroncek DF, Sabatino M, Feng Y, Dimitrov DS, Zhang L, Nguyen S, Qin H, Dropulic B, Lee DW, Mackall CL. CD22-targeted CAR T cells induce remission in B-ALL that is naive or resistant to CD19-targeted CAR immunotherapy. Nat Med. 2018 Jan;24(1):20-28. doi: 10.1038/nm.4441. Epub 2017 Nov 20.
Cordoba S, Onuoha S, Thomas S, Pignataro DS, Hough R, Ghorashian S, Vora A, Bonney D, Veys P, Rao K, Lucchini G, Chiesa R, Chu J, Clark L, Fung MM, Smith K, Peticone C, Al-Hajj M, Baldan V, Ferrari M, Srivastava S, Jha R, Arce Vargas F, Duffy K, Day W, Virgo P, Wheeler L, Hancock J, Farzaneh F, Domning S, Zhang Y, Khokhar NZ, Peddareddigari VGR, Wynn R, Pule M, Amrolia PJ. CAR T cells with dual targeting of CD19 and CD22 in pediatric and young adult patients with relapsed or refractory B cell acute lymphoblastic leukemia: a phase 1 trial. Nat Med. 2021 Oct;27(10):1797-1805. doi: 10.1038/s41591-021-01497-1. Epub 2021 Oct 12.
Dual CD19/CD22 CAR T Cells Show Feasibility in Pediatric/Young Adult B-ALL. Cancer Discov. 2021 Dec 1;11(12):2958. doi: 10.1158/2159-8290.CD-RW2021-150.
Other Identifiers
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CD19 & CD22 bispecific CAR T
Identifier Type: -
Identifier Source: org_study_id