Clinical trial · Interventional
AHSCT Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
NCT05740891CI-TRIAL-00064206unknownPhase 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)
Clinical Study on the Safety and Effectiveness of Autologous Hematopoietic Stem Cell Transplantation Combined With CAR-T Cells in the Treatment of Refractory and Relapsed Multiple Myeloma
Conditions
Conditions (1)
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 | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BCMA CAR-T cells injection | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment Group
- description
- Refractory and relapsed multiple myeloma
- interventionNames
- Drug: BCMA CAR-T cells injection
Primary outcomes (2)
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- Baseline up to 28 days after BCMA CAR T-cells infusion
- description
- Adverse events assessed according to NCI-CTCAE v5.0 criteria
- measure
- Incidence of treatment-emergent adverse events (TEAEs)
- timeFrame
- 24 months after cell infusion
- description
- Incidence of treatment-emergent adverse events \[Safety and Tolerability\]
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 1、BCMA positive accompanied by refractory/relapsed and resistance; * 2、Patients with the tumor load is high and cannot be transplanted directly, before transplantation. Reduce the load through CAR-T treatment to prepare for transplantation; * 3、Patient relapses after transplantation,donor lymphocyte infusion Invalid. The donor cells in the recipient body can be used or the donor cells can be collected directly.Prepare CAR-T to prevent recurrence and induce relapsing; * 4、Repeated MRD (+) refractory drug resistant cases; * 5、Male or female, 30-75 years old; * 6、Anticipated survival time more than 12 weeks * 7、Transplant subjects, regardless of their previous treatment, are eligible for inclusion after relapse; * 8、Patients had a negative urine pregnancy test before the start of administration and agreed to take effective contraceptive measures during the test period until the last follow-up; * 9、Those who voluntarily participate in the trial and sign the informed consent form Exclusion Criteria: * 1、Patients with the history of epilepsy or other CNS disease; * 2、Patients with prolonged QT interval time or severe heart disease; * 3、Pregnant or breastfeeding; * 4、Active infection with no cure; * 5、Patients with active hepatitis B or C infection; * 6、Previously treated with any genetic therapy; * 7、The proiferation rate is less than 5 times response to CD3/CD28 co-stimulation signal; * 8、Serum creatinine \> 2.5mg/dl or ALT / AST \> 3 times ULN or bilirubin \> 2.0mg/dl; * 9、Those who suffer from other uncontrolled diseases are not suitable to join the study; * 10、HIV infection; * 11、Any situation that the researchers believe may increase the risk of patients or interfere with the test results.
References
Publications (0)
Data not yet available
No reference posted for this study.