[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

+86 13627284963

Email address

jfzhou@tjh.tjmu.edu.cn

Condition

Relapsed/Refractory Multiple Myeloma

Treatment type

Interventional

Investigational product

IBI346

Phase

Phase 1

Sponsor

Huazhong University of Science and Technology

ClinicalTrials.gov identifier

NCT05266768

Study number

CIBI346Y002

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About the study

An open label, single-arm clinical study evaluating the safety and efficacy of IBI346 infusion in relapsed/refractory multiple myeloma

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

  1. Age 18 and above, no gender limitation.
  2. According to the multiple myeloma diagnostic criteria of the International Myeloma Working Group (IMWG), there is the initial diagnosis of multiple myeloma.
  3. Prior treatment of at least 3 lines of treatment, with at least 1 full treatment cycle for each line of treatment (unless the best recorded outcome is progressive disease (PD), according to IMWG criteria); Proteasome inhibitors and immunomodulators must be included.
  4. Documented disease progression during or within 12 months of the most recent anti-myeloma treatment.
  5. Determine the presence of measurable lesions during screening
  6. ECOG score is 0 or 1.
  7. Expected survival time ≥12 weeks.
Exclusion criteria

  1. Patients suffering from graft-versus-host disease (GVHD) or requiring immunosuppressants.
  2. Patients who received autologous hematopoietic stem cell transplantation (ASCT) or prior allogeneic hematopoietic stem cell transplantation (ALLo-HSCT) within 12 weeks prior to mononuclear cell collection.
  3. Prior BCMA targeted therapy.
  4. No unmobilized mononuclear cells can be collected for CAR T cell production.
  5. Screening subjects who were receiving systemic steroids during the previous 7 days or who were determined by the investigator to require long-term systemic steroid use during treatment (except for inhaled or topical use, except at doses < 10mg/ day).
  6. Patients with a history of hypertension that cannot be controlled by medication (blood pressure ≥140/90 mmHg).

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

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