FDA Clears IND for CT071 in RRMM and Primary Plasma Cell Leukemia

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CT071, a chimeric antigen receptor T-cell therapy candidate, had an investigational new drug application cleared by the FDA for patients with relapsed/refractory multiple myeloma and primary plasma cell leukemia.

  • An investigational new drug application was cleared by the FDA for CT071 in this indication.
  • CT071 is an autologous chimeric antigen receptor (CAR) T-cell therapy candidate being developed for the treatment of multiple myeloma (MM) and primary plasma cell leukemia (PCL).
  • A phase 1 trial evaluating CT071 is ongoing in China.

The FDA has cleared an investigational new drug application for CT071 for the treatment of patients with relapsed/refractory (R/R) MM or R/R primary PCL, according to CARsgen Therapeutics Holdings Limited.1

CT071 is an autologous CAR T-cell therapy candidate which incorporates a fully human single-chain variable fragment. The therapy works by targeting G protein-coupled receptor class C group 5 member D (GPRC5D). Due to the overexpression of GPRC5D on the surface of malignant plasma cells, as well as the limited presence of GPRC5D on normal tissues, this CAR T-cell therapy is an ideal candidate for the treatment of MM and PCL.

Manufactured with CARsgen's proprietary CARcelerate platform, CT071 yields younger, healthier, and possibly more potent CAR T cells vs conventional manufacturing as the manufacturing time is less than 2 days. The supply capacity is also enhanced with this platform, manufacturing costs are reduced, and the availability of the product and time to get it to the patient is expedited.

A phase 1 clinical trial (NCT05838131) in China is ongoing and evaluating the safety and efficacy of CT071 for the treatment of patients with RRMM or PCL.2

Male and female patients aged 18 years and older with MM who were resistant to at least 2 classes of anti-MM drugs (including at least 1 proteasome inhibitor), MM that failed at least 3 lines of therapy, secondary PCL that had received at least 1 line of therapy, and primary PCL that had progressed after treatment with at least 1 regimen will be included in the study. Patients are required to have progressive disease at the time of enrollment, have serum M-protein ≥ 5 g/L; 2. 24-hour urine M-protein ≥ 200 mg, abnormal serum free light chain (FLC) ratio and affected FLC ≥ 100 mg/L in subjects with MM who did not meet evaluable criteria for either serum or urine M-protein levels, or circulating plasma cells ≥ 5%. Patients also need to have an estimated survival of > 12 weeks, an ECOG performance status of 0-2 and adequate organ function to enroll in the study.

A negative serum pregnancy test at screening is required by all female patients of childbearing potential. They must also be willing to use a highly effective method of contraception within 1 year after receiving the trial treatment and absolutely prohibit egg donation during the trial and within 1 year after receiving the trial treatment. If sexually active with a female of childbearing potential, male patients must use a reliable form of contraception for 1 year after receiving trial treatment. Male patients are also prohibited from donating sperm during the trial and for 1 year after receiving the trial treatment.

REFERENCES:
  1. CARsgen's CT071 received IND clearance from the FDA for treating relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia. December 4, 2023. Accessed December 5, 2023. News release. CARsgen Therapeutics Holdings Limited. https://tinyurl.com/3r3wfefy
  2. Study of CT071 injection in RRMM or PPCL. Multiple Myeloma Research Foundation. Accessed December 5, 2023. https://tinyurl.com/df4hpcjb
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