CAR-T therapy for relapsed or refractory multiple myeloma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2 interventional trial evaluating a CAR-T cell therapy in adults with relapsed or refractory multiple myeloma. Eligible participants have received at least three prior lines of therapy or are refractory to both an IMiD and a proteasome inhibitor, and must have measurable disease and adequate organ function. The study screens for eligibility, collects safety and efficacy data, and follows patients to assess response, durability, and tolerability of the CAR-T treatment. Enrollment is conducted at the National University of Medical Sciences, Rawalpindi. Previous studies in similar CAR-T approaches have shown potential benefits in relapsed/refractory myeloma, guiding expectations for this trial.

Why it matters

Who can join: the full rules

Inclusion Criteria

1. Male and female participants of age 18 years and above.
2. Patients with a confirmed diagnosis of multiple myeloma according to IMWG diagnostic criteria.
3. Received at least 3 prior multiple myeloma treatment lines of therapy or are double refractory to an IMiD and PI (refractory multiple myeloma as defined by IMWG consensus criteria). Note: induction with or without hematopoietic stem cell transplant and with or without maintenance therapy is considered a single line of therapy.
4. Measurable disease at Screening as per IMWG criteria.
5. ECOG Performance Status grade of 0 to 2.
6. Adequate organ function: ANC/platelets thresholds (unless cytopenias attributable to MM), LVEF ≥45%, adequate oxygenation; hepatic/renal criteria specified in Section 10.
7. Negative pregnancy test for women of childbearing potential; agreement to effective contraception.
8. Patients giving written informed consent to participate in the study after a full understanding of the implications and constraints of the study protocol.
9. Understand the content of the ICF, and voluntarily sign the ICF (If the participant is unable to sign the ICF on their own due to illiteracy, an impartial witness is needed).
10. The subject can understand the research process and is willing and able to comply with all research proposals and other requirements of the study.
11. Willing and able to adhere to the prohibitions and restrictions specified in this protocol.

Exclusion Criteria

1\. Patients who will meet any of the following criteria will not be eligible to participate in the study.

1. Prior treatment with CAR-T therapy directed at any target. Any therapy that is targeted to BCMA.
2. Known active, or prior history of central nervous system (CNS) involvement, or exhibits clinical signs of meningeal involvement of multiple myeloma.
3. Stroke or seizure within 6 months of signing the ICF.
4. Uncontrolled active infection, including uncontrolled bacterial or fungal infection; active uncontrolled HBV/HCV/HIV.
5. Clinically significant cardiac disease (e.g., NYHA III/IV, recent MI), or severe pulmonary disease.
6. Recent allogeneic HSCT with active GVHD or ongoing immunosuppression.
7. Pregnant or breast-feeding, or planning to become pregnant while enrolled in this study or within 1 year after receiving study treatment.
8. Any other circumstances that would impair the ability of the participant to receive or tolerate the planned treatment at the investigational site, to understand informed consent, or any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments.

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   Exclusion Criteria:

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Where it's running

• National University of Medical Sciences, Clinical Trial Unit
  Rawalpindi, Punjab Province, Pakistan Recruiting
• National University of Medical Sciences, Clinical Trial Unit
  Rawalpindi, Punjab Province, Pakistan Recruiting

Study contacts

• Principal investigator: Tariq Ghafoor — National University of Medical Sciences
• Study coordinator: Nadia Sial, Ph.D
• Email: nadiaharif@gmail.com
• Phone: +923315582265

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• In Vivo BCMA-CAR T Cell Therapy for Relapsed or Refractory Multiple Myeloma

  This study tests VV169, a one-time in vivo CAR-T treatment, in adults with multiple myeloma that has come back or not responded to standard therapy.

  Recruiting Phase 1 Vyriad, Inc. · Rochester, Minnesota · NCT07802717

• Off-the-shelf BCMA CAR‑T for relapsed or refractory multiple myeloma

  This trial will try a universal (allogeneic) BCMA-directed CAR‑T cell treatment for people with relapsed or refractory multiple myeloma to see if it is safe and can reduce disease.

  Recruiting Bioray Laboratories · Shanghai · NCT07248176

• NT-I7 added to BCMA CAR-T therapy for relapsed or refractory multiple myeloma

  This trial tests whether giving NT-I7 after BCMA CAR-T therapy helps boost T-cell expansion and possibly improve responses in people with relapsed or refractory multiple myeloma.

  Recruiting Phase 1 Washington University School of Medicine · St Louis, Missouri · NCT07200089

• Sequential CAR-T therapy targeting BCMA and GPRC5D for relapsed or refractory multiple myeloma

  This will try sequential CAR-T cell therapy against BCMA and GPRC5D in people with relapsed or refractory multiple myeloma to see if it is safe and helps control the disease.

  Recruiting Phase 1/2 Essen Biotech · Beijing, Beijing Municipality · NCT07032129

• Testing a new CAR T-cell therapy for patients with advanced B-cell cancers

  This study is testing a new CAR T-cell therapy to see if it can help adults with hard-to-treat B-cell cancers feel better and improve their health.

  Recruiting Phase 1 Technische Universität Dresden · Dresden · NCT05836896

• APRIL CAR-T cell therapy for relapsed multiple myeloma patients

  This study is testing a new CAR-T cell therapy for patients with relapsed multiple myeloma to see if it is safe and effective for those who haven't responded well to other treatments.

  Recruiting Early Phase 1 Zhejiang University · Hangzhou, Zhejiang · NCT04657861

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.