Clinical trial · Interventional
Anti-CD19/BCMA Bispecific CAR-T Cell Therapy for R/R MM
Clinical Study of Anti-CD19/BCMA Bispecific Chimeric Antigen Receptors (CARs) T Cell Therapy for Relapsed and Refractory Multiple Myeloma
NCT03706547CI-TRIAL-00035300unknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this clinical trial is to study the feasibility and efficacy of anti-CD19/BCMA bispecific chimeric antigen receptors (CARs) T cell therapy for relapsed and refractory multiple myeloma.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma in Relapse | Multiple Myeloma | CURATED_BROADER | 0.78 |
| Multiple Myeloma Progression | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| anti-CD19/BCMA CAR-T cells | Biological | — | UNRESOLVED |
| Cyclophosphamide | Drug | Cyclophosphamide | ALIAS |
| Fludarabine | Drug | Fludarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- anti-CD19/BCMA CAR-T cells
- description
- 1. Chemotherapy with a classic combination with fludarabine and cyclophosphamide; 2. Administration with anti-CD19/BCMA CAR-T cells in the BCMA-positive multiple myeloma patients.
- interventionNames
- Biological: anti-CD19/BCMA CAR-T cells
- Drug: Fludarabine
- Drug: Cyclophosphamide
Primary outcomes (1)
- measure
- Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
- timeFrame
- 6 months
- description
- Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 4.0
Secondary outcomes (2)
- measure
- Overall remission rate defined by the standard response criteria for myeloma for each arm
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Expected survival \> 12 weeks * Diagnosis of Multiple Myeloma by IMWG updated criteria (2014) * Pathology demonstrated that BCMA-poitive malignant plasma cells exited in bone marrow or plamacytoma * Exited measurable lesions and in accordance with one of the following test indicators: serum M protein≥1 g/dl; urine M protein≥200 mg/24h; serum free light chain≥10 mg/dl; diagnosis of plasmacytoma by biopsy * The criteria for relapsed and refractory multiple myeloma: patients previously received at least 3 different prior treatment regimens for multiple myeloma, including protein inhibitors (eg: Bortezomib), and immunomodulator (eg: Revlimid), and have disease progression in the past 60 days * At least 90 days after stem cell transplantation * Clinical performance status of ECOG score 0-2 * Creatinine≤2.0 mg/dl * Bilirubin≤2.0 mg/dl * The ALT/AST value is lower than 2.5-fold of normal value * Accessible to intravenous injection, and no white blood cell collection contraindications * Sexually active patients must be willing to utilize one of the more effective birth control methods for 30 days after the CTL infusion. Male partner should use a condom * 5mg/day dose of Prednisone or other equivalent steroid hormone drugs (eg: Dexamethasone) were not used for two weeks before apheresis and CAR-T infusion * Able to understand and sign the Informed Consent Document. Exclusion Criteria: * Patients with symptoms of central nervous system * Patients with second malignancies in addition to multiple myeloma * Active hepatitis B or C, HIV infections * Any other active diseases could affect the enrollment of this trial * Long term use of immunosuppressive agents after organ transplantation, except currently receiving or recently received glucocorticoid treatment * Patients with organ failure * Women of child-bearing potential who are pregnant or breastfeeding during therapy, or have a planned pregnancy with 2 months after therapy * A history of mental illness and poorly controlled * Women of child-bearing potential who are not willing to practice birth control from the time of enrollment on this study and for 2 months after receiving the preparative regimen. Women of child bearing potential must have a negative serum or urine pregnancy test performed within 48 hours before infusion * Patients who are accounted by researchers to be not appropriate for this test * Subjects suffering disease affects the understanding of informed consent or complying with study protocol
References
Publications (30)
- BACKGROUNDSiegel RL, Miller KD, Jemal A. Cancer statistics, 2018. CA Cancer J Clin. 2018 Jan;68(1):7-30. doi: 10.3322/caac.21442. Epub 2018 Jan 4. PMID 29313949
- BACKGROUNDChild JA, Morgan GJ, Davies FE, Owen RG, Bell SE, Hawkins K, Brown J, Drayson MT, Selby PJ; Medical Research Council Adult Leukaemia Working Party. High-dose chemotherapy with hematopoietic stem-cell rescue for multiple myeloma. N Engl J Med. 2003 May 8;348(19):1875-83. doi: 10.1056/NEJMoa022340. PMID 12736280
- BACKGROUNDHari PN, McCarthy PL. Multiple myeloma: future directions in autologous transplantation and novel agents. Biol Blood Marrow Transplant. 2013 Jan;19(1 Suppl):S20-5. doi: 10.1016/j.bbmt.2012.11.002. No abstract available. PMID 23290439
- BACKGROUNDBruno B, Rotta M, Patriarca F, Mordini N, Allione B, Carnevale-Schianca F, Giaccone L, Sorasio R, Omede P, Baldi I, Bringhen S, Massaia M, Aglietta M, Levis A, Gallamini A, Fanin R, Palumbo A, Storb R, Ciccone G, Boccadoro M. A comparison of allografting with autografting for newly diagnosed myeloma. N Engl J Med. 2007 Mar 15;356(11):1110-20. doi: 10.1056/NEJMoa065464. PMID 17360989
- BACKGROUNDHideshima T, Podar K, Chauhan D, Ishitsuka K, Mitsiades C, Tai YT, Hamasaki M, Raje N, Hideshima H, Schreiner G, Nguyen AN, Navas T, Munshi NC, Richardson PG, Higgins LS, Anderson KC. p38 MAPK inhibition enhances PS-341 (bortezomib)-induced cytotoxicity against multiple myeloma cells. Oncogene. 2004 Nov 18;23(54):8766-76. doi: 10.1038/sj.onc.1208118. PMID 15480425
- BACKGROUNDShringarpure R, Catley L, Bhole D, Burger R, Podar K, Tai YT, Kessler B, Galardy P, Ploegh H, Tassone P, Hideshima T, Mitsiades C, Munshi NC, Chauhan D, Anderson KC. Gene expression analysis of B-lymphoma cells resistant and sensitive to bortezomib. Br J Haematol. 2006 Jul;134(2):145-56. doi: 10.1111/j.1365-2141.2006.06132.x. PMID 16846475