NCT04194931

Humanized CAR-T Cells of Anti-BCAM and Anti-CD19 Against Relapsed and Refractory Multiple Myeloma

Status unknown Phase 1 Last updated 11 December 2019

What this trial tests

Phase 1 trial testing Autologous BCMA CAR-T cells and CD19 CAR-T cells in Relapsed or Refractory Multiple Myeloma in 20 participants. Status unknown.

Timeline

1 December 2019

Primary endpoint
31 December 2020

31 December 2020

Quick facts

Lead sponsor	The First Affiliated Hospital of Nanchang University
Phase	Phase 1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	1 December 2019
Primary completion	31 December 2020
Estimated completion	31 December 2020
Sites	1 location across China

Drugs / interventions tested

• Autologous BCMA CAR-T cells and CD19 CAR-T cells — full drug profile →

Conditions studied

• Relapsed or Refractory Multiple Myeloma — all drugs for Relapsed or Refractory Multiple Myeloma →

Sponsor

The First Affiliated Hospital of Nanchang University

Who can join

Adults 18 to 70, any sex, with Relapsed or Refractory Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a single arm, open-label, single center study to evaluate the safety and efficacy of BCMA/CD19 CAR-T cells in patients with BCMA+，CD19+ relapsed or refractory multiple myeloma.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Patient selection for CAR T or BiTE therapy in multiple myeloma: Which treatment for each patient?
   Kegyes D, Constantinescu C, Vrancken L, Rasche L, et al · · 2022 · cited 53× · PMID 35672793 · DOI 10.1186/s13045-022-01296-2
2. Minimal Residual Disease in Multiple Myeloma: Current Landscape and Future Applications With Immunotherapeutic Approaches.
   Kostopoulos IV, Ntanasis-Stathopoulos I, Gavriatopoulou M, Tsitsilonis OE, et al · · 2020 · cited 42× · PMID 32537439 · DOI 10.3389/fonc.2020.00860
3. Next-generation chimeric antigen receptors for T- and natural killer-cell therapies against cancer.
   Li Y, Rezvani K, Rafei H. · · 2023 · cited 29× · PMID 37548050 · DOI 10.1111/imr.13255
4. Promising Antigens for the New Frontier of Targeted Immunotherapy in Multiple Myeloma.
   Cho SF, Xing L, Anderson KC, Tai YT. · · 2021 · cited 28× · PMID 34885245 · DOI 10.3390/cancers13236136
5. Infusion and delivery strategies to maximize the efficacy of CAR-T cell immunotherapy for cancers.
   Gu X, Zhang Y, Zhou W, Wang F, et al · · 2024 · cited 21× · PMID 39061100 · DOI 10.1186/s40164-024-00542-2
6. Emerging therapies for relapsed/refractory multiple myeloma: CAR-T and beyond.
   Su CT, Ye JC. · · 2021 · cited 21× · PMID 34301270 · DOI 10.1186/s13045-021-01109-y
7. CAR T-Cells in Multiple Myeloma Are Ready for Prime Time.
   Rodríguez-Otero P, Prósper F, Alfonso A, Paiva B, et al · · 2020 · cited 20× · PMID 33172026 · DOI 10.3390/jcm9113577
8. Adoptive Cellular Therapy for Multiple Myeloma Using CAR- and TCR-Transgenic T Cells: Response and Resistance.
   Füchsl F, Krackhardt AM. · · 2022 · cited 16× · PMID 35159220 · DOI 10.3390/cells11030410