Last reviewed · How we verify

NCT03711864

Safety and Efficacy of IM21 Car-t Cells in Patients With Recurrent or Refractory BCMA Positive Multiple Myeloma

Status unknown Phase 1 Last updated 30 September 2020
What this trial tests

Phase 1 trial testing IM21 CAR-T cells in Multiple Myeloma in 15 participants. Status unknown.

Timeline
25 February 2019
Primary endpoint
10 October 2021
20 December 2021

Quick facts

Lead sponsorPeking Union Medical College Hospital
PhasePhase 1
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment15
Start date25 February 2019
Primary completion10 October 2021
Estimated completion20 December 2021
Sites1 location across China

Drugs / interventions tested

Conditions studied

Sponsor

Peking Union Medical College Hospital

Who can join

Adults 18 to 80, any sex, with Multiple Myeloma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In patients with multiple myeloma with recurrent or refractory BCMA, CAR-T cell infusion was performed after screening, blood collection and pretreatment. Starting dose for 5 x 10\^5 / kg, 1 x 10\^6 doses sequentially. If dose-limiting toxicity is not observed in 3 patients in a dose group, the next dose group test can be performed; If more than 2/3 of patients (2 cases, included) in a dose group had DLT, dose-escalation was not performed. If 1 case of DLT (1/3) appears in the first 3 patients of a dose group, 3 patients need to be added to the dose group (at this time, there are 6 patients in the group).

Publications & conference data

3 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. 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
  3. Gene Modified CAR-T Cellular Therapy for Hematologic Malignancies.
    Lin WY, Wang HH, Chen YW, Lin CF, et al · · 2020 · cited 13× · PMID 33212810 · DOI 10.3390/ijms21228655

Verify or expand the search:

Other trials of IM21 CAR-T cells

Trials testing the same drug.

Other recruiting trials for Multiple Myeloma

Currently open trials in the same condition.

Other Peking Union Medical College Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03711864.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing